Evaluation of the Kolcaba’s comfort theory combined ERAS care in patients with nasal deformities: study protocol of a randomized controlled trial

Evaluation of the Kolcaba’s comfort theory combined ERAS care in patients with nasal deformities: study protocol of a randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Evaluation of the Kolcaba’s comfort theory combined ERAS care in patients with nasal deformities: study protocol of a randomized controlled trial Yue Wang, Qianlin Zeng, Qi Zhang, Yu Tian, Yunping Fan, Yueqi Sun, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3847261/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Patients with nasal deformities (ND) in the perioperative period face a multitude of physical and psychological issues. This study aims to develop and assess the efficacy of specialized nursing interventions based on Kolcaba's Comfort Theory in conjunction with Enhanced Recovery After Surgery (KCT-ERAS) tailored for ND patients. Methods and analysis: The research team formulated a nursing intervention protocol through a systematic review of literature and expert consultation. This protocol will be evaluated via a randomized controlled trial. ND patients admitted to a single medical facility within a specific timeframe will be randomly allocated into two groups in a 1:1 ratio. The KCT-ERAS group will receive comprehensive nursing interventions, including preoperative care (environmental preparation, health education, psychological counseling, shared decision-making, dietary management, and adaptation training), intraoperative temperature and fluid management, and postoperative care (early mobilization and feeding, pain management, and specialized nasal nursing). In contrast, the control group will receive standard nursing care. Primary outcomes include the length of hospitalization (LOH), comfort levels, and nursing satisfaction. Secondary outcomes are complications, anxiety levels, sleep quality, specialty quality of life (SQOF), pain intensity, and dry mouth. Discussion This study establishes a scientifically-backed perioperative care protocol for ND patients based on evidence-based medicine. The KCT-ERAS model is expected to enhance recovery outcomes for patients undergoing ND corrective surgery, offering a scientifically-informed, patient-centric nursing approach during the ND perioperative period. Trial registration: It has been approved by China Clinical Trial Registry on December 7, 2023 (No. ChiCTR2300078407). Figures Figure 1 Figure 2 Introduction Nasal deformity (ND), a complex anatomical abnormality, is highly prevalent among otolaryngology patients 1 . It involves deviations in the nasal bone, upper and lower lateral cartilages, and the septum from the face's midsagittal plane 2 . Due to both aesthetic and functional concerns, patients with nasal deformities often seek to improve their condition through corrective surgery 3,4 . However, this surgery is associated with various stress reactions and complications, including breathing difficulties, pain, sleep disturbances, crusting, nasal bleeding, swallowing difficulties, and adhesions 5 . Additionally, studies have indicated that ND patients frequently encounter psychological issues post-surgery 6 . Research has revealed that targeted nursing interventions can effectively alleviate these concerns. Strategies such as shortening preoperative fasting, implementing early postoperative feeding 7 , providing detailed health education and psychological guidance, and offering specialized care can significantly reduce nasal complications and patient discomfort 8 . Therefore, effective nursing interventions are crucial for postoperative recovery in the perioperative period, yet there is a notable gap in systematic nursing care studies specifically for ND corrective surgery in this critical timeframe. Currently, Enhanced recovery after surgery (ERAS) concept has been established as an effective approach and a key factor in perioperative care for various surgeries 9 . ERAS is an evidence-based approach, involving a multidisciplinary collaboration among anesthesia, nursing, and surgical teams. Its goal is to optimize perioperative measures and processes, leading to reduced complications and promoting early patient recovery 10 . However, the focus of ERAS predominantly lies on objective measures such as length of hospitalization (LOH), associated complications, and hospital costs. Importantly, the subjective comfort experience during treatment is increasingly recognized as crucial for clinical outcomes and patient safety 11 . This aspect aligns well with the application of Kolcaba's Comfort Theory (KCT) 12 , which concentrates on four dimensions of patient care physical, psycho-spiritual, sociocultural, and environmental to achieve a state of health characterized by relaxation, satisfaction, and freedom from anxiety and pain 13 . Studies have shown that the KCT-ERAS combined model, when applied to patients undergoing laparoscopic cholecystectomy, can reduce stress reactions, alleviate psychological disorders, improve psychological states, and accelerate disease treatment 14 . Consequently, there is a growing trend in employing the Kolcaba's Comfort Theory in conjunction with Enhanced Recovery After Surgery(KCT-ERAS)combined nursing model across various surgical procedures. The unique physiological, aesthetic, functional, and anatomical characteristics of the nasal cavity significantly affect the perioperative comfort of patients with ND. Implementing tailored nursing measures to mitigate adverse reactions and enhance comfort is essential for improving their quality of life. Therefore, this study aims to scientifically develop specific nursing protocols based on the KCT-ERAS concept, addressing the perioperative health challenges faced by patients undergoing ND correction surgery. Methods This study is divided into two stages: Stage 1: Development of the KCT-ERAS Model Nursing Protocol (Fig. 1 ) Theme Research themes were identified based on clinical problem significance, innovation, and feasibility. The protocol was designed in accordance with standards and specifications for developing Chinese clinical practice guidelines 15 . Team : A multidisciplinary research team was established, comprising otorhinolaryngologists, anesthesiologists, ENT head nurses, supervisor nurses, and anesthesia nurses. Responsibilities were divided: the otolaryngologist managed the overall patient treatment plan and surgery; the head nurse oversaw nursing care plan design, organized expert interviews, and adjusted plans based on feedback; the supervisor nurse developed individualized care plans and coordinated patient communication; the anesthesiologist and anesthesia nurse managed intraoperative pain, temperature, and fluid balance; an additional nurse, not involved in interventions, collected patient outcomes; and the head nurse and supervising physician ensured quality control and safety of the protocol. Program The program included an extensive literature review and clinical experience to address specific nursing needs for ND perioperative correction surgery 3,16,17 . Two rounds of online expert consultations refined the nursing protocol, focusing on accuracy of outcome measures and assessment timing. Proposal Clinical guidelines for ND were finalized based on expert opinion, statistical analysis, and research meetings. Ethical approval was sought from the Medical Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University, followed by clinical study registration. KCT-ERAS Group Management Protocol (Fig. 2 ) The protocol focusing on physiological, psychological, social, and environmental interventions to enhance patient comfort during all surgical phases. Preoperative phase Environment Management: The ward temperature should be maintained at 22-25 degrees Celsius to ensure patient comfort. Mixed lighting is recommended to meet a standard of 100–300 lx, balancing both light and darkness appropriately. Noise levels should be limited to 45dB during daytime and 40dB at night to create a tranquil environment. Additionally, playing soft music at suitable times can significantly aid in alleviating patient anxiety 19-20 . Psychological Support: More than 45 minutes of dedicated communication will be provided, encompassing a comprehensive assessment of the patient's physical and psychosocial state. Patients will actively participate in developing their individualized care plan, based on the principles of shared decision-making theory（SMD） 20 . Nurses will distribute pertinent written materials and thoroughly explain the KCT-ERAS care approach, including disease knowledge and perioperative considerations. Psychological counseling will be offered, and family members will be encouraged to provide social support to enhance treatment adherence. Skin Preparation: It is advisable to trim nasal hair with sterile scissors a day before surgery 21 and to perform nasal irrigation, especially if there's an increase in nasal secretions. Fasting Period: Patients are required to fast for solids for 6 hours and are allowed to consume carbohydrate-rich clear liquids up to a maximum volume of 400ml until 2 hours before the surgery 7,17 . Habilitation Training: Patients will be positioned either in a semi-recumbent or supine position. The charge nurse will place cotton balls in each nostril and guide the patients to open their lips in an "a" shape and inhale deeply, with the abdomen drawing in and the chest rising for a duration of 3 seconds. Subsequently, patients will be instructed to slightly close their lips in an "O" shape and exhale, allowing the chest to lower and the abdomen to relax completely. This inhalation and exhalation sequence will be repeated for one set, and after completing five sets, a rest period of 10 seconds will be observed. Patients will then take 10 ml of warm water into their mouth and slowly let it flow down with their breath, relaxing the base of the tongue during swallowing. This training for nasal congestion, swallowing, and breathing cycles will be conducted for 10 minutes each session, three times a day 22 . Respiratory Preparation: Patients are advised to quit smoking and limit excessive alcohol consumption for 4 weeks before the surgery 23 . Additionally, they should rinse their mouths with antiseptic mouth rinses such as chlorhexidine (0.2%) and Listerine, starting one day prior to the surgery and repeating this process 2-3 times a day 24 . Intraoperative phase Body Temperature Management: Maintaining the patient's body temperature at or above 36.0°C is crucial. The core temperature will be continuously monitored during surgery and for one hour postoperatively using the SpotOnTM Monitoring System. To ensure precise temperature readings, the patient's limb temperature will be regularly assessed. This will be achieved by employing an infusion warming device to heat fluids to 38℃ and using a forced-air warmer to maintain the patient's body temperature 25 . Fluid Management: The anesthesiology team will carefully control intraoperative fluid input. Infusion rates will be maintained at approximately 6–7 ml/kg/h ( 27 ), and the total volume of fluid administered will be restricted to 1.75–2.75 L/day ( 28 ). This precise management of fluid input is designed to optimize patient outcomes and minimize potential complications related to fluid balance during surgery. Postoperative phase Early Mobilization: Patients are encouraged to begin mobilization two hours post-surgery. This includes getting out of bed with appropriate measures in place to prevent falls. Initially, they should aim for a walking duration of over 30 minutes. By the second postoperative day, this duration can be increased to exceed 60 minutes, progressively enhancing their physical activity and recovery 25 . Early Eating and Drinking: Based on the findings of the referenced study 9 , early oral intake is recommended approximately 2 hours after surgery, assuming the absence of symptoms like nausea and vomiting. The initial dietary recommendation is a 200ml semi-liquid diet. Depending on gastrointestinal tolerance, the diet can be advanced to light and high-calorie foods after 4 hours. Pain Management: Pain intensity will be evaluated using the Visual Analog Scale (VAS) at specific intervals (2h, 6h, 12h, 24h, and 48h) following the surgery. Upon returning to the ward, ice will be applied to the frontal area as part of the pain management strategy. Starting 2 hours postoperatively, pain management will include the administration of non-steroidal anti-inflammatory drugs (NSAIDs), customized according to the patient's pain levels 26 . Upper Respiratory Tract Care: To alleviate congestion and reduce mucosal swelling, a cold compress will be applied postoperatively 27 . Given that nasal packing may necessitate mouth breathing, patients will be instructed to use a humidified mask to mitigate oral dryness. Additionally, nebulizer treatments with Budesonide suspension (0.5 mg/ml) will be administered as part of the care routine. Throughout the intervention process, precise assessments will be conducted at multiple time points. The effectiveness of these interventions will be systematically compared between the intervention group and the control group, ensuring a thorough evaluation of the treatment protocol. Control Group Management Protocol In the preoperative stage, the ward temperature is maintained between 18–22 degrees Celsius to ensure patient comfort. Preoperative nurses provide comprehensive education about disease knowledge and perioperative precautions during this stage. Patients are advised to fast for 8 hours and to limit water 4 hours before surgery, and nasal hair is trimmed using sterile nasal razors to maintain a hygienic environment. Transitioning to the intraoperative stage, body temperature is meticulously controlled, and routine fluid therapy is administered according to the established protocol. This ensures a stable and optimal environment during the surgery. In the postoperative stage, patients are allowed to resume oral intake 6 hours after surgery, provided they do not exhibit symptoms like nausea or vomiting. The initial diet is light, with a gradual transition to normal dietary intake as tolerated. Early mobilization is highly encouraged 6 hours after surgery to facilitate recovery. While routine analgesic use is not a standard procedure, temporary analgesics are available and administered as necessary, especially in cases where the patient experiences pain. Regarding upper respiratory care, specialized treatment is not the norm; however, nebulized treatment with budesonide suspension may be employed if deemed necessary. These protocols and measures are carefully followed to ensure a seamless and comfortable perioperative experience for patients. Stage 2: Validation of the Effectiveness and Safety of the KCT-ERAS Management Protocol Participant Recruitment This single-blind, parallel randomized controlled trial is conducted at the Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong Province, China. Patient recruitment is set to commence in January 2024, with consecutive enrollment. Eligibility criteria include a diagnosis of nasal deformity with deviated nasal septum 28 . Baseline demographic information will be collected, and eligibility confirmed before the head nurse employs computer-based randomization using SPSS software and a random number table, ensuring unbiased group allocation. Participants are required to sign informed consent forms upon admission. This study has received approval from the hospital's ethics committee. The inclusion and exclusion criteria are detailed in Table 1 . Table 1 The list of exclusion and inclusion criteria No. Inclusion criteria Exclusion criteria 1 18–60 years old Previous history of nasal deformity surgery 2 Meets the diagnostic criteria of nasal deformity with deviated septum With hypertension and other systemic diseases 3 Voluntarily participate in the study, and sign an informed consent form With mental disorders, cognitive impairment 4 Do not have coagulation disorders Pregnant or lactating women 5 Communicate normally and do not have mental disorders Patients with aphasia and deafness, unable to communicate normally Sample Size Calculation Designed as a parallel randomized controlled study, the primary outcomes include LOH, complications, and patient comfort status. Based on prior research ( 32 ), LOH is estimated at 5 days for the test group and 8 days for the control group, with standard deviations of 1.05 and 1.1, respectively. Setting the significance level (α) at 0.05 (two-tailed) and power (1-β) at 0.9, the sample size for each group (N1 = N2) is calculated to be 20 using PASS 15 software. Considering a 10% dropout rate, the total required sample size is 44 cases, expanded to approximately 50–60 cases. Assessment Procedure Primary endpoints include LOH, complications, and comfort status, while secondary endpoints are nursing satisfaction, anxiety levels, sleep quality, specialty quality of life (SQOF), pain, and dry mouth intensity. Assessments are scheduled at multiple time points: admission (T1), half an hour before surgery (T2), 2, 6, and 24 hours post-surgery (T3, T4, T5), post-nasal packing removal (T6), discharge (T7), and 1, 3, 12, 24 months post-surgery (T8, T9, T10, T11). Specific assessment tools and time points are summarized in Table 2 . Table 2 The list of assessment tools and assessment timepoints Category Assessment tools Time points T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 Primary endpoint LOH Electronic Medical Record System √ Complications Electronic Medical Record System √ Comfort Kolcaba General Comfort Questionnaire, GCQ √ √ √ √ √ √ Secondary endpoint Anxiety Zung Anxiety Self-Assessment Scale, SAS √ √ √ √ √ √ Sleep Medical Outcomes Study-Sleep Scale, MOS-SS √ √ √ √ √ √ SQOF 22-Item Sinonasal Outcome Test, SNOT-22 √ √ √ √ √ Pain Visual analog scale, VAS √ √ √ √ Dry mouth Visual analog scale, VAS √ √ √ √ Nursing satisfaction Self-made questionnaire in our hospital √ Data Collection and Management Data collection and analysis will be confidential. Objective data are sourced from the electronic medical record system. Subjective outcomes are gathered by an interviewer not involved in patient care and blinded to group assignments, using Questionnaire Star platform. Data are processed and managed in the ResMan clinical study electronic collection system by two independent researchers. Statistical Analysis LOH is calculated from admission to discharge, with complications noted in the electronic medical record system. Comfort status is assessed using the GCQ scale 29 , with scoring criteria ranging from "more comfortable" (96–100) to "extremely uncomfortable" (≤ 75). Anxiety levels are measured by the SAS scale 30 , sleep quality by the MOS-SS scale 31 , specialty quality of life by the SNOT-22 32 , and pain/dry mouth by the VAS 33 . Data are analyzed using IBM SPSS software, Version 26 (IBM, lnc, Chicago, USA). Continuous variables are expressed as means ± standard deviation or median and interquartile range, depending on distribution. Independent samples t-tests and nonparametric tests are used for variable analysis, with chi-square tests for categorical data like postoperative complications. A P value < 0.05 is considered statistically significant. Discussion ND correction surgery can induce significant physical and psychological discomfort 5,6 . The KCT-ERAS nursing protocol has been effective in enhancing physical comfort, expediting recovery, and improving emotional well-being 34 . However, there is a notable gap in high-quality, systematic KCT-ERAS nursing plans for perioperative ND care. To bridge this gap, we have developed the first systematic KCT-ERAS nursing model for ND surgery's perioperative period. This model includes personalized shared SDM plan, health education, psychological support, environmental adjustments, dietary management, and pain control, providing a comprehensive and individualized care approach. Gaining insight into the patient's psychospiritual and sociocultural perspectives is crucial for optimal care. SDM, a collaborative approach integrating medical evidence with the patient’s circumstances and values, has shown positive outcomes in thyroid and nasal surgery, reducing anxiety and improving recovery confidence and satisfaction 35,36 . The application of SDM in ND patients is particularly pertinent, considering both anatomical and aesthetic factors that are closely linked to the patient’s subjective experiences. Environmental quality is increasingly valued, with the sensory environment of the ward being a key component of patient comfort. Positive environmental modifications, like art and music, can reduce anxiety, shorten hospital stays, and improve sleep quality 37 , while reducing stressors such as light and noise 19 . The KCT-ERAS program tailors environmental adjustments to enhance physical comfort and satisfaction. Dietary management is pivotal in perioperative care. Shortened fasting periods and early resumption of diet, as shown in research 38 ., have beneficial effects such as reduced surgical stress response and improved gastrointestinal function. Our protocol adopts these principles, significantly improving patient comfort during the perioperative period. Effective pain management, transitioning from traditional postoperative pain focus to preemptive analgesia with NSAIDs, has shown to greatly improve comfort and hasten recovery. This proactive approach addresses pain before it begins, enhancing patient comfort and overall recovery outcomes. Special nursing measures tailored to ND’s perioperative period, like preoperative adaptation training, can prevent issues like dry mouth and aid in adapting to postoperative changes, thereby reducing depressive emotions post-surgery 22 . Additionally, nasal cold compresses and moist masks can alleviate facial swelling, pain, and dry mouth symptoms. Combining comfort care theory with ERAS concepts for ND perioperative care is innovative, addressing physiological, psychological, social, and environmental discomfort factors through targeted measures. This multidisciplinary, multimodal nursing process aims to improve care quality, benefiting both medical practitioners and patients. However, the study has limitations, such as the lack of a scientific Delphi survey in expert consultations, and the possibility of more comprehensive care details. Future research should refine the ND-specific nursing program and further assess the KCT-ERAS model’s specific effects. Strengths and Limitations of This Study Strengths: The protocol effectively monitors and regulates environmental factors such as light, noise, and temperature to create a comfortable setting for patients. Patient stress is significantly reduced through shared decision-making, shortened fasting periods, and proactive pain management strategies. Preoperative behavioral training is implemented to enhance patients' adaptability to nasal packing, improving their postoperative experience. Limitations: The expert consultation process lacked the robustness of a scientific Delphi survey, potentially impacting the scientific validity of the intervention measures. The care details provided in this study could have been more comprehensive. Incorporating additional adjunctive strategies might have further optimized the effectiveness of patient care. List Of Abbreviations Nasal deformity ND Enhanced recovery after surgery ERAS Kolcaba comfort theory KCT Shared decision- making SDM Length of hospitalization (LOH) LOH Specialty quality of life SQOF Visual analog scale VAS Non-steroidal anti-inflammatory drugs NSAIDs Kolcaba General Comfort Questionnaire GCQ Zung Anxiety Self-Assessment Scale SAS Medical Outcomes Study-Sleep Scale MOS-SS 22-Item Sinonasal Outcome Test SNOT-22 Declarations Ethics approval and consent to participate ： The study protocol (KY-2023-106-01) was approved by the Medical Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University on November 10, 2023. Informed consent will be obtained from all participants Consent for publication: First, written consent will be obtained from patients prior to enrollment in this study protocol. Second, the faces appearing in figure one and two of this manuscript are the author's original character images, which do not involve character likeness rights. At last, all the authors of the manuscript have given their consent to the public release of the entire contents of the manuscript. Competing interests: The authors declare no conflicts of interest. Funding: None. Author contributions: Yue Wang , study design, data collection, data acquisition, manuscript composition, quality control throughout; Qianlin Zeng , data collection, data analysis, manuscript composition; Yu Tian, Qi Zhang , study design, manuscript review; Yueqi Sun , data analysis, manuscript review; Yunping Fan , technical support, supervision; Jiaoqiong Guan , visualization, manuscript composition and quality control throughout; Yunping Deng , study design, manuscript review, project administration, quality control throughout. All authors contributed to the article and approved the submitted version. Availability of data and material ： Not applicable. References Mladina R, Cujić E, Subarić M, Vuković K. 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Joshi GP, Abdelmalak BB, Weigel WA, et al. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023;138(2):132–51. 10.1097/ALN.0000000000004381 . Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3847261","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":267814326,"identity":"23d33b82-5851-47ac-9f13-f08798d948e2","order_by":0,"name":"Yue Wang","email":"","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Yue","middleName":"","lastName":"Wang","suffix":""},{"id":267814327,"identity":"36276aec-655b-413c-99ef-cb1ba4dae543","order_by":1,"name":"Qianlin Zeng","email":"","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Qianlin","middleName":"","lastName":"Zeng","suffix":""},{"id":267814328,"identity":"b5a79ca6-28ad-440b-a533-517ccde780bf","order_by":2,"name":"Qi Zhang","email":"","orcid":"","institution":"Sichuan University","correspondingAuthor":false,"prefix":"","firstName":"Qi","middleName":"","lastName":"Zhang","suffix":""},{"id":267814329,"identity":"2e40c4d3-8589-4006-a375-f6a1a575140d","order_by":3,"name":"Yu Tian","email":"","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Yu","middleName":"","lastName":"Tian","suffix":""},{"id":267814330,"identity":"be6046b5-8047-4e07-af62-500af075f229","order_by":4,"name":"Yunping Fan","email":"","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Yunping","middleName":"","lastName":"Fan","suffix":""},{"id":267814331,"identity":"892a83d1-9ac0-4b27-ad05-88602f775360","order_by":5,"name":"Yueqi Sun","email":"","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Yueqi","middleName":"","lastName":"Sun","suffix":""},{"id":267814332,"identity":"fc65b1a2-9622-4207-812f-51d279055bf0","order_by":6,"name":"Jiaoqiong Guan","email":"","orcid":"","institution":"Sichuan University","correspondingAuthor":false,"prefix":"","firstName":"Jiaoqiong","middleName":"","lastName":"Guan","suffix":""},{"id":267814333,"identity":"4193fb1a-b925-4dd1-8159-c99525df966e","order_by":7,"name":"Yunping Deng","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9klEQVRIiWNgGAWjYDCCA1CajYGB8QGYJUGCFmYD0rSAdEkQpYXveO/h17xtd/L4pNuvVf5sq0ucP7uB8cPHHNxaJM+cS7PmbXtWzCZzpuw2b9vhxA13DjBLztyGW4vBjRwzY5DKNomctNuMbQcSN0gksDHz4tNy/w1CSyHYYTMIabnBY/wYoiX9GANvG3Niww0CWiTP5Jgxzjl3uJhNIodZmufcYeMNNxKb8fqF7/gZ4w9vyg7nyc9If/jxR1md7PwZyQc/fMSjBQjYpHgYGBIYGHgMGBjZQAKMDXjVAwHzxx9gLewPGBj+EFI8CkbBKBgFIxEAAONiWZqmolcyAAAAAElFTkSuQmCC","orcid":"","institution":"Seventh Affiliated Hospital of Sun Yat-sen University","correspondingAuthor":true,"prefix":"","firstName":"Yunping","middleName":"","lastName":"Deng","suffix":""}],"badges":[],"createdAt":"2024-01-09 04:59:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3847261/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3847261/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":49994360,"identity":"01cc78d7-bd67-4aaa-b5fb-8ab30ecb398c","added_by":"auto","created_at":"2024-01-22 19:35:46","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":239844,"visible":true,"origin":"","legend":"\u003cp\u003eDeveloping flow chart of KCT-ERAS model nursing protocol\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3847261/v1/0110ae249e96155f088b07ba.jpg"},{"id":49994959,"identity":"a97f5d04-fc27-4650-bbcd-3992d5de88f2","added_by":"auto","created_at":"2024-01-22 19:43:46","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":514704,"visible":true,"origin":"","legend":"\u003cp\u003eSchematic diagram of comparison between KCT-ERAS model and control nursing protocol\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3847261/v1/8eb6a12f234cdf4b4d67735a.jpg"},{"id":52679505,"identity":"0447d9b5-377b-4c82-9b28-8a6aa9b55aae","added_by":"auto","created_at":"2024-03-14 12:10:53","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":760491,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3847261/v1/b8fc01d0-3efd-4fac-9ae5-d51e39729634.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluation of the Kolcaba’s comfort theory combined ERAS care in patients with nasal deformities: study protocol of a randomized controlled trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eNasal deformity (ND), a complex anatomical abnormality, is highly prevalent among otolaryngology patients \u003csup\u003e1\u003c/sup\u003e. It involves deviations in the nasal bone, upper and lower lateral cartilages, and the septum from the face's midsagittal plane \u003csup\u003e2\u003c/sup\u003e. Due to both aesthetic and functional concerns, patients with nasal deformities often seek to improve their condition through corrective surgery\u003csup\u003e3,4\u003c/sup\u003e. However, this surgery is associated with various stress reactions and complications, including breathing difficulties, pain, sleep disturbances, crusting, nasal bleeding, swallowing difficulties, and adhesions\u003csup\u003e5\u003c/sup\u003e. Additionally, studies have indicated that ND patients frequently encounter psychological issues post-surgery\u003csup\u003e6\u003c/sup\u003e. Research has revealed that targeted nursing interventions can effectively alleviate these concerns. Strategies such as shortening preoperative fasting, implementing early postoperative feeding\u003csup\u003e7\u003c/sup\u003e, providing detailed health education and psychological guidance, and offering specialized care can significantly reduce nasal complications and patient discomfort\u003csup\u003e8\u003c/sup\u003e. Therefore, effective nursing interventions are crucial for postoperative recovery in the perioperative period, yet there is a notable gap in systematic nursing care studies specifically for ND corrective surgery in this critical timeframe.\u003c/p\u003e \u003cp\u003eCurrently, Enhanced recovery after surgery (ERAS) concept has been established as an effective approach and a key factor in perioperative care for various surgeries\u003csup\u003e9\u003c/sup\u003e. ERAS is an evidence-based approach, involving a multidisciplinary collaboration among anesthesia, nursing, and surgical teams. Its goal is to optimize perioperative measures and processes, leading to reduced complications and promoting early patient recovery\u003csup\u003e10\u003c/sup\u003e. However, the focus of ERAS predominantly lies on objective measures such as length of hospitalization (LOH), associated complications, and hospital costs. Importantly, the subjective comfort experience during treatment is increasingly recognized as crucial for clinical outcomes and patient safety\u003csup\u003e11\u003c/sup\u003e. This aspect aligns well with the application of Kolcaba's Comfort Theory (KCT)\u003csup\u003e12\u003c/sup\u003e, which concentrates on four dimensions of patient care physical, psycho-spiritual, sociocultural, and environmental to achieve a state of health characterized by relaxation, satisfaction, and freedom from anxiety and pain\u003csup\u003e13\u003c/sup\u003e. Studies have shown that the KCT-ERAS combined model, when applied to patients undergoing laparoscopic cholecystectomy, can reduce stress reactions, alleviate psychological disorders, improve psychological states, and accelerate disease treatment\u003csup\u003e14\u003c/sup\u003e. Consequently, there is a growing trend in employing the Kolcaba's Comfort Theory in conjunction with Enhanced Recovery After Surgery(KCT-ERAS)combined nursing model across various surgical procedures.\u003c/p\u003e \u003cp\u003eThe unique physiological, aesthetic, functional, and anatomical characteristics of the nasal cavity significantly affect the perioperative comfort of patients with ND. Implementing tailored nursing measures to mitigate adverse reactions and enhance comfort is essential for improving their quality of life. Therefore, this study aims to scientifically develop specific nursing protocols based on the KCT-ERAS concept, addressing the perioperative health challenges faced by patients undergoing ND correction surgery.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis study is divided into two stages:\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eStage 1: Development of the KCT-ERAS Model Nursing Protocol (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/h2\u003e\n \u003cp\u003e\u003cstrong\u003eTheme\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eResearch themes were identified based on clinical problem significance, innovation, and feasibility. The protocol was designed in accordance with standards and specifications for developing Chinese clinical practice guidelines\u003csup\u003e15\u003c/sup\u003e.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eTeam\u003c/strong\u003e: A multidisciplinary research team was established, comprising otorhinolaryngologists, anesthesiologists, ENT head nurses, supervisor nurses, and anesthesia nurses. Responsibilities were divided: the otolaryngologist managed the overall patient treatment plan and surgery; the head nurse oversaw nursing care plan design, organized expert interviews, and adjusted plans based on feedback; the supervisor nurse developed individualized care plans and coordinated patient communication; the anesthesiologist and anesthesia nurse managed intraoperative pain, temperature, and fluid balance; an additional nurse, not involved in interventions, collected patient outcomes; and the head nurse and supervising physician ensured quality control and safety of the protocol.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eProgram\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eThe program included an extensive literature review and clinical experience to address specific nursing needs for ND perioperative correction surgery\u003csup\u003e3,16,17\u003c/sup\u003e. Two rounds of online expert consultations refined the nursing protocol, focusing on accuracy of outcome measures and assessment timing.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eProposal\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eClinical guidelines for ND were finalized based on expert opinion, statistical analysis, and research meetings. Ethical approval was sought from the Medical Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University, followed by clinical study registration.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n \u003ch2\u003eKCT-ERAS Group Management Protocol (Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/h2\u003e\n \u003cp\u003eThe protocol focusing on physiological, psychological, social, and environmental interventions to enhance patient comfort during all surgical phases.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n \u003ch2\u003ePreoperative phase\u003c/h2\u003e\n \u003col\u003e\n \u003cli\u003eEnvironment Management: The ward temperature should be maintained at 22-25 degrees Celsius to ensure patient comfort. Mixed lighting is recommended to meet a standard of 100\u0026ndash;300 lx, balancing both light and darkness appropriately. Noise levels should be limited to 45dB during daytime and 40dB at night to create a tranquil environment. Additionally, playing soft music at suitable times can significantly aid in alleviating patient anxiety\u003csup\u003e19-20\u003c/sup\u003e.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePsychological Support: More than 45 minutes of dedicated communication will be provided, encompassing a comprehensive assessment of the patient\u0026apos;s physical and psychosocial state. Patients will actively participate in developing their individualized care plan, based on the principles of shared decision-making theory（SMD）\u003csup\u003e20\u003c/sup\u003e. Nurses will distribute pertinent written materials and thoroughly explain the KCT-ERAS care approach, including disease knowledge and perioperative considerations. Psychological counseling will be offered, and family members will be encouraged to provide social support to enhance treatment adherence.\u003c/li\u003e\n \u003cli\u003eSkin Preparation: It is advisable to trim nasal hair with sterile scissors a day before surgery\u003csup\u003e21\u003c/sup\u003e and to perform nasal irrigation, especially if there\u0026apos;s an increase in nasal secretions.\u003c/li\u003e\n \u003cli\u003e\u0026nbsp;Fasting Period: Patients are required to fast for solids for 6 hours and are allowed to consume carbohydrate-rich clear liquids up to a maximum volume of 400ml until 2 hours before the surgery\u003csup\u003e7,17\u003c/sup\u003e.\u003c/li\u003e\n \u003cli\u003eHabilitation Training: Patients will be positioned either in a semi-recumbent or supine position. The charge nurse will place cotton balls in each nostril and guide the patients to open their lips in an \u0026quot;a\u0026quot; shape and inhale deeply, with the abdomen drawing in and the chest rising for a duration of 3 seconds. Subsequently, patients will be instructed to slightly close their lips in an \u0026quot;O\u0026quot; shape and exhale, allowing the chest to lower and the abdomen to relax completely. This inhalation and exhalation sequence will be repeated for one set, and after completing five sets, a rest period of 10 seconds will be observed. Patients will then take 10 ml of warm water into their mouth and slowly let it flow down with their breath, relaxing the base of the tongue during swallowing. This training for nasal congestion, swallowing, and breathing cycles will be conducted for 10 minutes each session, three times a day\u003csup\u003e22\u003c/sup\u003e.\u003c/li\u003e\n \u003cli\u003eRespiratory Preparation: Patients are advised to quit smoking and limit excessive alcohol consumption for 4 weeks before the surgery\u003csup\u003e23\u003c/sup\u003e. Additionally, they should rinse their mouths with antiseptic mouth rinses such as chlorhexidine (0.2%) and Listerine, starting one day prior to the surgery and repeating this process 2-3 times a day\u003csup\u003e24\u003c/sup\u003e.\u003c/li\u003e\n \u003c/ol\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\n \u003ch2\u003eIntraoperative phase\u003c/h2\u003e\n \u003col\u003e\n \u003cli\u003eBody Temperature Management: Maintaining the patient\u0026apos;s body temperature at or above 36.0\u0026deg;C is crucial. The core temperature will be continuously monitored during surgery and for one hour postoperatively using the SpotOnTM Monitoring System. To ensure precise temperature readings, the patient\u0026apos;s limb temperature will be regularly assessed. This will be achieved by employing an infusion warming device to heat fluids to 38℃ and using a forced-air warmer to maintain the patient\u0026apos;s body temperature\u003csup\u003e25\u003c/sup\u003e.\u003c/li\u003e\n \u003cli\u003eFluid Management: The anesthesiology team will carefully control intraoperative fluid input. Infusion rates will be maintained at approximately 6\u0026ndash;7 ml/kg/h (\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e), and the total volume of fluid administered will be restricted to 1.75\u0026ndash;2.75 L/day (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). This precise management of fluid input is designed to optimize patient outcomes and minimize potential complications related to fluid balance during surgery.\u003c/li\u003e\n \u003c/ol\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003ePostoperative phase\u003c/h2\u003e\n \u003col\u003e\n \u003cli\u003e\n \u003cp\u003eEarly Mobilization: Patients are encouraged to begin mobilization two hours post-surgery. This includes getting out of bed with appropriate measures in place to prevent falls. Initially, they should aim for a walking duration of over 30 minutes. By the second postoperative day, this duration can be increased to exceed 60 minutes, progressively enhancing their physical activity and recovery\u003csup\u003e25\u003c/sup\u003e.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eEarly Eating and Drinking: Based on the findings of the referenced study\u003csup\u003e9\u003c/sup\u003e, early oral intake is recommended approximately 2 hours after surgery, assuming the absence of symptoms like nausea and vomiting. The initial dietary recommendation is a 200ml semi-liquid diet. Depending on gastrointestinal tolerance, the diet can be advanced to light and high-calorie foods after 4 hours.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003ePain Management: Pain intensity will be evaluated using the Visual Analog Scale (VAS) at specific intervals (2h, 6h, 12h, 24h, and 48h) following the surgery. Upon returning to the ward, ice will be applied to the frontal area as part of the pain management strategy. Starting 2 hours postoperatively, pain management will include the administration of non-steroidal anti-inflammatory drugs (NSAIDs), customized according to the patient\u0026apos;s pain levels\u003csup\u003e26\u003c/sup\u003e.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eUpper Respiratory Tract Care: To alleviate congestion and reduce mucosal swelling, a cold compress will be applied postoperatively\u003csup\u003e27\u003c/sup\u003e. Given that nasal packing may necessitate mouth breathing, patients will be instructed to use a humidified mask to mitigate oral dryness. Additionally, nebulizer treatments with Budesonide suspension (0.5 mg/ml) will be administered as part of the care routine.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n \u003cp\u003eThroughout the intervention process, precise assessments will be conducted at multiple time points. The effectiveness of these interventions will be systematically compared between the intervention group and the control group, ensuring a thorough evaluation of the treatment protocol.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eControl Group Management Protocol\u003c/h2\u003e\n \u003cp\u003eIn the preoperative stage, the ward temperature is maintained between 18\u0026ndash;22 degrees Celsius to ensure patient comfort. Preoperative nurses provide comprehensive education about disease knowledge and perioperative precautions during this stage. Patients are advised to fast for 8 hours and to limit water 4 hours before surgery, and nasal hair is trimmed using sterile nasal razors to maintain a hygienic environment.\u003c/p\u003e\n \u003cp\u003eTransitioning to the intraoperative stage, body temperature is meticulously controlled, and routine fluid therapy is administered according to the established protocol. This ensures a stable and optimal environment during the surgery.\u003c/p\u003e\n \u003cp\u003eIn the postoperative stage, patients are allowed to resume oral intake 6 hours after surgery, provided they do not exhibit symptoms like nausea or vomiting. The initial diet is light, with a gradual transition to normal dietary intake as tolerated. Early mobilization is highly encouraged 6 hours after surgery to facilitate recovery. While routine analgesic use is not a standard procedure, temporary analgesics are available and administered as necessary, especially in cases where the patient experiences pain.\u003c/p\u003e\n \u003cp\u003eRegarding upper respiratory care, specialized treatment is not the norm; however, nebulized treatment with budesonide suspension may be employed if deemed necessary. These protocols and measures are carefully followed to ensure a seamless and comfortable perioperative experience for patients.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eStage 2:\u003c/h2\u003e\n \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e\n \u003ch2\u003eValidation of the Effectiveness and Safety of the KCT-ERAS Management Protocol\u003c/h2\u003e\n \u003cdiv id=\"Sec11\" class=\"Section4\"\u003e\n \u003ch2\u003eParticipant Recruitment\u003c/h2\u003e\n \u003cp\u003eThis single-blind, parallel randomized controlled trial is conducted at the Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong Province, China. Patient recruitment is set to commence in January 2024, with consecutive enrollment. Eligibility criteria include a diagnosis of nasal deformity with deviated nasal septum\u003csup\u003e28\u003c/sup\u003e. Baseline demographic information will be collected, and eligibility confirmed before the head nurse employs computer-based randomization using SPSS software and a random number table, ensuring unbiased group allocation.\u003c/p\u003e\n \u003cp\u003eParticipants are required to sign informed consent forms upon admission. This study has received approval from the hospital\u0026apos;s ethics committee. The inclusion and exclusion criteria are detailed in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u0026nbsp;\u003c/p\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe list of exclusion and inclusion criteria\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNo.\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eInclusion criteria\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eExclusion criteria\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18\u0026ndash;60 years old\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePrevious history of nasal deformity surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMeets the diagnostic criteria of nasal deformity with deviated septum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWith hypertension and other systemic\u003c/p\u003e\n \u003cp\u003ediseases\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVoluntarily participate in the study, and sign an informed consent form\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWith mental disorders, cognitive impairment\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDo not have coagulation disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePregnant or lactating women\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCommunicate normally and do not have mental disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients with aphasia and deafness, unable to communicate normally\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eSample Size Calculation\u003c/h2\u003e\n \u003cp\u003eDesigned as a parallel randomized controlled study, the primary outcomes include LOH, complications, and patient comfort status. Based on prior research (\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e), LOH is estimated at 5 days for the test group and 8 days for the control group, with standard deviations of 1.05 and 1.1, respectively. Setting the significance level (\u0026alpha;) at 0.05 (two-tailed) and power (1-\u0026beta;) at 0.9, the sample size for each group (N1\u0026thinsp;=\u0026thinsp;N2) is calculated to be 20 using PASS 15 software. Considering a 10% dropout rate, the total required sample size is 44 cases, expanded to approximately 50\u0026ndash;60 cases.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eAssessment Procedure\u003c/h2\u003e\n \u003cp\u003ePrimary endpoints include LOH, complications, and comfort status, while secondary endpoints are nursing satisfaction, anxiety levels, sleep quality, specialty quality of life (SQOF), pain, and dry mouth intensity. Assessments are scheduled at multiple time points: admission (T1), half an hour before surgery (T2), 2, 6, and 24 hours post-surgery (T3, T4, T5), post-nasal packing removal (T6), discharge (T7), and 1, 3, 12, 24 months post-surgery (T8, T9, T10, T11). Specific assessment tools and time points are summarized in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u0026nbsp;\u003c/p\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe list of assessment tools and assessment timepoints\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"2\" rowspan=\"2\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eAssessment tools\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"11\"\u003e\n \u003cp\u003eTime points\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"3\"\u003e\n \u003cp\u003ePrimary endpoint\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLOH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eElectronic Medical Record System\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eComplications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eElectronic Medical Record System\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eComfort\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eKolcaba General Comfort Questionnaire, GCQ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" rowspan=\"6\"\u003e\n \u003cp\u003eSecondary endpoint\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAnxiety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eZung Anxiety Self-Assessment Scale, SAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSleep\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedical Outcomes Study-Sleep Scale, MOS-SS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSQOF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e22-Item Sinonasal Outcome Test, SNOT-22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisual analog scale, VAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDry mouth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisual analog scale, VAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNursing satisfaction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSelf-made questionnaire in our hospital\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026radic;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003eData Collection and Management\u003c/h2\u003e\n \u003cp\u003eData collection and analysis will be confidential. Objective data are sourced from the electronic medical record system. Subjective outcomes are gathered by an interviewer not involved in patient care and blinded to group assignments, using Questionnaire Star platform. Data are processed and managed in the ResMan clinical study electronic collection system by two independent researchers.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical Analysis\u003c/h2\u003e\n \u003cp\u003eLOH is calculated from admission to discharge, with complications noted in the electronic medical record system. Comfort status is assessed using the GCQ scale\u003csup\u003e29\u003c/sup\u003e, with scoring criteria ranging from \u0026quot;more comfortable\u0026quot; (96\u0026ndash;100) to \u0026quot;extremely uncomfortable\u0026quot; (\u0026le;\u0026thinsp;75). Anxiety levels are measured by the SAS scale\u003csup\u003e30\u003c/sup\u003e, sleep quality by the MOS-SS scale\u003csup\u003e31\u003c/sup\u003e, specialty quality of life by the SNOT-22\u003csup\u003e32\u003c/sup\u003e, and pain/dry mouth by the VAS \u003csup\u003e33\u003c/sup\u003e. Data are analyzed using IBM SPSS software, Version 26 (IBM, lnc, Chicago, USA). Continuous variables are expressed as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or median and interquartile range, depending on distribution. Independent samples t-tests and nonparametric tests are used for variable analysis, with chi-square tests for categorical data like postoperative complications. A P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 is considered statistically significant.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eND correction surgery can induce significant physical and psychological discomfort\u003csup\u003e5,6\u003c/sup\u003e. The KCT-ERAS nursing protocol has been effective in enhancing physical comfort, expediting recovery, and improving emotional well-being\u003csup\u003e34\u003c/sup\u003e. However, there is a notable gap in high-quality, systematic KCT-ERAS nursing plans for perioperative ND care. To bridge this gap, we have developed the first systematic KCT-ERAS nursing model for ND surgery's perioperative period. This model includes personalized shared SDM plan, health education, psychological support, environmental adjustments, dietary management, and pain control, providing a comprehensive and individualized care approach.\u003c/p\u003e \u003cp\u003eGaining insight into the patient's psychospiritual and sociocultural perspectives is crucial for optimal care. SDM, a collaborative approach integrating medical evidence with the patient\u0026rsquo;s circumstances and values, has shown positive outcomes in thyroid and nasal surgery, reducing anxiety and improving recovery confidence and satisfaction\u003csup\u003e35,36\u003c/sup\u003e. The application of SDM in ND patients is particularly pertinent, considering both anatomical and aesthetic factors that are closely linked to the patient\u0026rsquo;s subjective experiences.\u003c/p\u003e \u003cp\u003eEnvironmental quality is increasingly valued, with the sensory environment of the ward being a key component of patient comfort. Positive environmental modifications, like art and music, can reduce anxiety, shorten hospital stays, and improve sleep quality\u003csup\u003e37\u003c/sup\u003e, while reducing stressors such as light and noise\u003csup\u003e19\u003c/sup\u003e. The KCT-ERAS program tailors environmental adjustments to enhance physical comfort and satisfaction.\u003c/p\u003e \u003cp\u003eDietary management is pivotal in perioperative care. Shortened fasting periods and early resumption of diet, as shown in research\u003csup\u003e38\u003c/sup\u003e., have beneficial effects such as reduced surgical stress response and improved gastrointestinal function. Our protocol adopts these principles, significantly improving patient comfort during the perioperative period.\u003c/p\u003e \u003cp\u003eEffective pain management, transitioning from traditional postoperative pain focus to preemptive analgesia with NSAIDs, has shown to greatly improve comfort and hasten recovery. This proactive approach addresses pain before it begins, enhancing patient comfort and overall recovery outcomes.\u003c/p\u003e \u003cp\u003eSpecial nursing measures tailored to ND\u0026rsquo;s perioperative period, like preoperative adaptation training, can prevent issues like dry mouth and aid in adapting to postoperative changes, thereby reducing depressive emotions post-surgery \u003csup\u003e22\u003c/sup\u003e. Additionally, nasal cold compresses and moist masks can alleviate facial swelling, pain, and dry mouth symptoms.\u003c/p\u003e \u003cp\u003eCombining comfort care theory with ERAS concepts for ND perioperative care is innovative, addressing physiological, psychological, social, and environmental discomfort factors through targeted measures. This multidisciplinary, multimodal nursing process aims to improve care quality, benefiting both medical practitioners and patients. However, the study has limitations, such as the lack of a scientific Delphi survey in expert consultations, and the possibility of more comprehensive care details. Future research should refine the ND-specific nursing program and further assess the KCT-ERAS model\u0026rsquo;s specific effects.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and Limitations of This Study\u003c/h2\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003eStrengths:\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe protocol effectively monitors and regulates environmental factors such as light, noise, and temperature to create a comfortable setting for patients.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePatient stress is significantly reduced through shared decision-making, shortened fasting periods, and proactive pain management strategies.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePreoperative behavioral training is implemented to enhance patients' adaptability to nasal packing, improving their postoperative experience.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eLimitations:\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe expert consultation process lacked the robustness of a scientific Delphi survey, potentially impacting the scientific validity of the intervention measures.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThe care details provided in this study could have been more comprehensive. Incorporating additional adjunctive strategies might have further optimized the effectiveness of patient care.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"List Of Abbreviations","content":"\u003cdiv\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\" style=\"margin-right: calc(50%); width: 50%;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eNasal deformity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eND\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eEnhanced recovery after surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eERAS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eKolcaba comfort theory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eKCT\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eShared decision- making\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eSDM\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eLength of hospitalization (LOH)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eLOH\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eSpecialty quality of life\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eSQOF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eVisual analog scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eVAS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eNon-steroidal anti-inflammatory drugs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eNSAIDs\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eKolcaba General Comfort Questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eGCQ\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eZung Anxiety Self-Assessment Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eSAS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003eMedical Outcomes Study-Sleep Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eMOS-SS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"78.78787878787878%\" style=\"width: 60.4877%;\"\u003e\n \u003cp\u003e22-Item Sinonasal Outcome Test\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.21212121212121%\" style=\"width: 39.2935%;\"\u003e\n \u003cp\u003eSNOT-22\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003cstrong\u003e：\u003c/strong\u003eThe study protocol (KY-2023-106-01) was approved by the Medical Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University on November 10, 2023. Informed consent will be obtained from all participants\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e First, written consent will be obtained from patients prior to enrollment in this study protocol. Second, the faces appearing in figure one and two of this manuscript are the author\u0026apos;s original character images, which do not involve character likeness rights. At last, all the authors of the manuscript have given their consent to the public release of the entire contents of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNone.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions: Yue Wang\u003c/strong\u003e, study design, data collection, data acquisition, manuscript composition,\u0026nbsp;quality control throughout; \u003cstrong\u003eQianlin Zeng\u003c/strong\u003e, data collection, data analysis, manuscript composition;\u003cstrong\u003e\u0026nbsp;Yu Tian, Qi Zhang\u0026nbsp;\u003c/strong\u003e, study design, manuscript review;\u0026nbsp;\u003cstrong\u003eYueqi Sun\u003c/strong\u003e,\u0026nbsp;data analysis,\u0026nbsp;manuscript review;\u0026nbsp;\u003cstrong\u003eYunping Fan\u003c/strong\u003e, technical support,\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003esupervision;\u003cstrong\u003e\u0026nbsp;Jiaoqiong Guan\u003c/strong\u003e,\u0026nbsp;visualization,\u0026nbsp;manuscript composition\u0026nbsp;and quality control throughout; \u003cstrong\u003eYunping Deng\u003c/strong\u003e, study design, manuscript review,\u0026nbsp;project administration,\u0026nbsp;quality control throughout. All authors contributed to the article and approved the submitted version.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material\u003c/strong\u003e\u003cstrong\u003e：\u003c/strong\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMladina R, Cujić E, Subarić M, Vuković K. Nasal septal deformities in ear, nose, and throat patients: an international study. Am J Otolaryngol. 2008;29(2):75\u0026ndash;82. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.amjoto.2007.02.002\u003c/span\u003e\u003cspan address=\"10.1016/j.amjoto.2007.02.002\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaraca H. Using the Septal Shift Technique to Correct Crooked Nose Deformity. 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Anesthesiology. 2023;138(2):132\u0026ndash;51. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/ALN.0000000000004381\u003c/span\u003e\u003cspan address=\"10.1097/ALN.0000000000004381\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-3847261/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3847261/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePatients with nasal deformities (ND) in the perioperative period face a multitude of physical and psychological issues. This study aims to develop and assess the efficacy of specialized nursing interventions based on Kolcaba's Comfort Theory in conjunction with Enhanced Recovery After Surgery (KCT-ERAS) tailored for ND patients.\u003c/p\u003e\u003ch2\u003eMethods and analysis:\u003c/h2\u003e \u003cp\u003eThe research team formulated a nursing intervention protocol through a systematic review of literature and expert consultation. This protocol will be evaluated via a randomized controlled trial. ND patients admitted to a single medical facility within a specific timeframe will be randomly allocated into two groups in a 1:1 ratio. The KCT-ERAS group will receive comprehensive nursing interventions, including preoperative care (environmental preparation, health education, psychological counseling, shared decision-making, dietary management, and adaptation training), intraoperative temperature and fluid management, and postoperative care (early mobilization and feeding, pain management, and specialized nasal nursing). In contrast, the control group will receive standard nursing care. Primary outcomes include the length of hospitalization (LOH), comfort levels, and nursing satisfaction. Secondary outcomes are complications, anxiety levels, sleep quality, specialty quality of life (SQOF), pain intensity, and dry mouth.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThis study establishes a scientifically-backed perioperative care protocol for ND patients based on evidence-based medicine. The KCT-ERAS model is expected to enhance recovery outcomes for patients undergoing ND corrective surgery, offering a scientifically-informed, patient-centric nursing approach during the ND perioperative period.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eIt has been approved by China Clinical Trial Registry on December 7, 2023 (No. ChiCTR2300078407).\u003c/p\u003e","manuscriptTitle":"Evaluation of the Kolcaba’s comfort theory combined ERAS care in patients with nasal deformities: study protocol of a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-22 19:35:42","doi":"10.21203/rs.3.rs-3847261/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8de8e2c6-c60d-4062-9e08-eccf27b683ac","owner":[],"postedDate":"January 22nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-14T12:02:43+00:00","versionOfRecord":[],"versionCreatedAt":"2024-01-22 19:35:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3847261","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3847261","identity":"rs-3847261","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}