The effects of music therapy on pain and anxiety in young nulliparous patients undergoing laparoscopic cystectomy for endometriosis: a randomized controlled trial

Background Endometriosis (EMS) is associated with a markedly increased incidence of depression and anxiety, primarily due to cyclic pain, concerns about infertility from impaired ovarian function, and fear of disease recurrence. Surgery and its associated pain may trigger both emotional and physiological stress responses. Young, nulliparous patients with fertility intentions often experience additional psychological burdens related to surgical safety, postoperative recovery, and the potential impact on future fertility. Music has been shown to promote relaxation, reduce tension and anxiety, and alleviate pain. However, no studies have evaluated the postoperative effects of music therapy in this specific patient population.

To investigate whether music therapy can effectively reduce postoperative pain and alleviate perioperative anxiety in young patients with fertility desires undergoing laparoscopic cystectomy for endometriotic ovarian cysts, and to explore its potential as a simple, non-pharmacological intervention. Methods/Design A single-center, two-arm, single-masked randomized controlled trial (RCT). Setting The Third Affiliated Hospital of Sun Yat-sen University (a teaching hospital). Participants A total of 149 patients were included for analysis, with 75 assigned to the music group and 74 to the control group. Intervention Perioperative music therapy administered to young, nulliparous patients with fertility intentions undergoing laparoscopic cystectomy for EMS.

One participant withdrew during follow-up, and 149 patients were included in the final analysis. Baseline characteristics—including age, BMI, marital status, preoperative VAS scores, and GAD-7 scores and anxiety levels—showed no significant differences between groups. Postoperative VAS scores at 6 h (p = 0.20), Day 1 (p = 0.438), Day 3 (p = 0.714), and Day 7 (p = 0.899) revealed no significant differences. Similarly, GAD-7 scores and anxiety severity levels on postoperative Day 1 (p = 0.541; p = 0.984), Day 3 (p = 0.287; p = 0.436), and Day 7 (p = 0.468; p = 0.703) showed no statistical significance between groups.

Music therapy may serve as an adjunctive intervention for young, nulliparous patients with fertility intentions undergoing laparoscopic cystectomy for endometriosis; however, no significant effects were observed in reducing perioperative anxiety or postoperative pain in this population.

Endometriosis (EMS) is a common gynecological disorder affecting approximately 10–15% of women of reproductive age, with up to 50% of affected individuals experiencing pelvic pain or infertility [Citation1,Citation2]. Treatment of EMS is often prolonged and costly [Citation3]. Cyclic pain episodes can reduce work productivity and impair sexual satisfaction. Concerns about ovarian damage, infertility, and disease recurrence extend the impact of EMS beyond physical symptoms to social, occupational, and emotional domains [Citation4]. As a result, patients often exhibit increased vulnerability to psychological conditions, with significantly higher rates of depression and anxiety [Citation5]. Psychological research identifies pain as a key predictor of both depression and anxiety, while severe psychological distress heightens pain perception [Citation6]. In a study by Soliman et al. involving 2,004 Canadian EMS patients and 26,528 controls, pelvic pain was associated with significantly reduced quality of life and increased anxiety and depressive symptoms [Citation7]. Vannuccin conducted a cross-sectional analysis of 134 Italian patients, revealing that approximately 59% experienced emotional disorders closely correlated with pain severity [Citation8]. Lulia Baciu showed that 52.72% of urban patients in Romania reported reduced work efficiency and limited career advancement due to pain, contributing to emotional distress [Citation9]. The infertility rate among individuals with EMS reaches up to 40% [Citation10]. Women with EMS-related infertility often face substantial psychological pressure from personal, familial, and societal expectations, exacerbating anxiety and depression. Matasariu found that 22% of patients reported relationship changes linked to infertility caused by EMS [Citation11]. A survey by Graaff of 100 Dutch partners revealed that approximately 20% experienced intimacy issues due to infertility or sexual dysfunction related to EMS [Citation12]. Detailed research remains lacking on anxiety and depression among young, nulliparous patients undergoing laparoscopic cystectomy for endometriotic ovarian cysts. Surgical procedures and the associated postoperative pain can be emotionally and physically distressing experiences that may trigger anxiety and psychological stress [Citation13]. Unfamiliar hospital environments, loss of control, perceived surgical risks, and fear of postoperative pain are all contributing factors to the development of anxiety and depression [Citation14]. In the context of reproductive health, additional concerns often arise regarding future fertility and the potential impact on sexual function [Citation15]. Scientific studies have confirmed that listening to music can significantly increase the levels of endorphins in human blood. These endogenous neuropeptides bind to opioid receptors and produce analgesic and pleasurable effects similar to morphine and opioids, functioning as natural pain relievers. Music has been shown to promote relaxation, reduce tension and anxiety, and consequently alleviate the perception of pain [Citation16]. At present, music therapy may serve as a potential approach to help manage anxiety, stress, and pain in young, nulliparous patients with fertility desires undergoing laparoscopic cystectomy for endometriotic ovarian cysts. Among various non-pharmacological interventions, music therapy has received considerable attention for its effectiveness in reducing perioperative pain and anxiety. This method is safe, simple, and cost-effective. Numerous studies have demonstrated that music therapy helps relieve postoperative pain, improves patient satisfaction, and reduces postoperative nausea and vomiting [Citation17]. Although the effectiveness of music therapy remains debated, with some studies reporting beneficial analgesic effects and others suggesting limited impact, no research to date has specifically examined its application in young, nulliparous EMS patients with fertility desires following surgery. Patients in this population often experience heightened anxiety and depression due to concerns about surgical safety, postoperative recovery, disease recurrence, and potential declines in ovarian function that may affect future fertility. Reducing perioperative anxiety, stress, and pain may offer significant benefits for these individuals. The present study aims to evaluate the effects of music therapy on postoperative pain and pre-and postoperative anxiety in young, nulliparous patients with fertility needs undergoing laparoscopic surgery for EMS. Participants and methods Study subjects From September 2023 to August 2024, patients admitted to the Department of Gynecology at the Third Affiliated Hospital of Sun Yat-sen University and scheduled to undergo laparoscopic cystectomy for endometriotic ovarian cysts were recruited. All participants were young, nulliparous women with reproductive intentions. Inclusion criteria: Patients undergoing elective laparoscopic cystectomy for endometriotic ovarian cysts. Age between 20 and 35 years, nulliparous, with a desire for future fertility. Willingness to comply with medical treatment protocols and complete follow-up assessments. Written informed consent provided prior to enrollment. Exclusion criteria: Diagnosis of malignant tumors. Presence of psychiatric and/or cognitive disorders that prevent understanding of the study’s purpose or compliance with medical advice. Aversion to music. Concurrent chronic pain disorders. Hearing impairment. Refusal to participate in the study. Discontinuation and withdrawal criteria: Inability to adhere to music therapy, making ssessment of clinical efficacy unfeasible. Incomplete clinical data that could compromise the evaluation of efficacy or safety. Emergence of strong emotional resistance during the study period. The investigator provides justification for early withdrawal and evaluates the participant’s status at the time of discontinuation. Management of dropouts: For participants who discontinue the study, investigators will attempt to contact them by phone to document reasons for withdrawal and record the last treatment date. Any feasible assessments will be completed. If assessment is impossible, a clinical observation summary form will be completed, noting the primary reason for discontinuation. After study completion, data from all dropout cases will be compiled and included in the final statistical analysis. Interventions Group allocation and intervention measures: Participants were randomly assigned to one of two groups: Intervention group: standard care + laparoscopic cystectomy for endometriotic ovarian cysts + music therapy. Control group: standard care + laparoscopic cystectomy for endometriotic ovarian cysts. Standard care: For patients with a history of diabetes, preoperative blood glucose control was implemented, aiming for preprandial glucose between 4.4–7.2 mmol/L, postprandial glucose below 10 mmol/L, and HbA1c below 7%. For patients with a history of hypertension, preoperative blood pressure control was applied with a target of <140/80 mmHg. Other underlying conditions, such as hyperthyroidism, were managed to achieve stable status prior to surgery, ensuring the exclusion of surgical contraindications. Surgical procedure: Preoperative preparation and anesthesia: On the day before surgery, patients underwent vaginal irrigation, fasting, enema, skin preparation, and cleansing of the umbilical region. General anesthesia was induced using combined intravenous and inhalation techniques with endotracheal intubation. Operative technique: Under general anesthesia, patients were placed in the lithotomy position. Four abdominal incisions (0.5–1 cm in length) were made to insert laparoscopic instruments. After incising the surface of the endometriotic cyst, two atraumatic instruments were used to provide traction and counter traction for cyst enucleation. Normal saline irrigation and suturing were performed, with minimal use of bipolar electrosurgical energy. All adhesions and lesions were carefully dissected and removed. Ovarian mobility was confirmed postoperatively. All resected specimens were submitted for pathological examination. Music therapy: Music intervention began one day before surgery and continued daily for seven days postoperatively, constituting one treatment course. Patients listened to preselected music at a comfortable volume for 30 minutes daily, either through speakers or headphones. Music selection was based on the “Music for Emotional Regulation” module within the “Cloud SanYuan” WeChat mini-program of the Third Affiliated Hospital of Sun Yat-sen University. A wide range of musical styles was available, allowing patients to choose their preferred type (fast and powerful, moderately paced and cheerful, or slow and soothing). Each session was limited to 30 minutes. Pretreatment assessment General information: Baseline demographic data were collected, including age, sex, marital status, educational level, occupation, household income, and musical preferences. Clinical characteristics: Relevant clinical variables were documented, including the presence of infertility symptoms, comorbidities, cyst location, cyst size, and current medication use. Confounding factors documentation Surgical Factors: (1) ASRM staging of EMS; (2) Presence of deep infiltrating endometriosis (DIE); (3) Placement of postoperative drainage tubes; (4) Type of skin closure (external sutures vs. subcuticular sutures). Anesthesia-related factors: (1) Type of anesthetic agents administered; (2) Dosage of anesthetic agents; (3) Use of local subcutaneous anesthetic injections. Postoperative analgesia: (1) Type of analgesics administered; (2) Frequency of analgesic use; (3) Use of postoperative patient-controlled analgesia (PCA) pumps. Methodology Blinding Music therapy in this study was administered while patients were conscious, making it infeasible to implement blinding for participants. Additionally, due to the daily administration of music therapy and frequent patient-provider communication, blinding of physicians was not feasible. However, data analysts remained blinded throughout the study. Statistical analysis was conducted by personnel independent of the study team to ensure objectivity. Randomization A single-center, two-arm, single-blind randomized controlled trial (RCT) design was adopted. Randomization was performed using a random number table generated in SPSS version 25.0. Eligible participants were enrolled sequentially and assigned to the intervention or control group according to the generated random numbers and their corresponding allocation. Sample size calculation Sample size estimation was performed using the online tool POWER AND SAMPLE SIZE (http://powerandsamplesize.com/Calculators/) with the single-sample, two-sided equality test option. Based on previous literature, an alpha level (Type I error) of 0.1 and a power (1 − β) of 0.8 were used. Assuming a true proportion (p) of 0.5 and a null hypothesis proportion (p0) of 0.3 and accounting for a 20% dropout rate, the required sample size was approximately 44 participants per group. Therefore, a total of 88 patients were needed for both groups combined. Statistical analysis All data were initially entered and validated using Microsoft Excel, and statistical analyses were performed with SPSS version 26.0. Two-tailed tests were applied for all statistical analyses, with a P-value < 0.05 considered statistically significant. Continuous variables were tested for normality; those conforming to a normal distribution were expressed as mean ± standard deviation, while non-normally distributed variables were described as median (interquartile range). Categorical variables were presented as frequencies and proportions. Statistical methods were selected according to data types: categorical data were analyzed using the chi-square test or Fisher’s exact test; continuous variables meeting normality and homogeneity of variance assumptions were compared using the t-test, whereas non-normally distributed data were analyzed with the Wilcoxon signed-rank test; ordinal data were compared using the Mann–Whitney U test or the Kruskal–Wallis test for multi-group comparisons. A predefined statistical analysis plan guided the entire process, including data validation, descriptive statistics, baseline comparison, efficacy assessment, recurrence evaluation, safety analysis, and handling of dropout cases. Baseline comparability between groups was assessed using demographic and clinical variables. Post-treatment comparisons of primary and secondary efficacy outcomes and laboratory indicators were conducted between and within groups. If baseline imbalance in potential confounding factors such as age, disease severity, or disease duration was identified, analysis of covariance was applied to adjust for their influence on the results. Ethics The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and relevant clinical research regulations and guidelines. Approval was obtained from the Institutional Ethics Committee prior to study initiation. Before enrollment, all participants were informed of the study’s objectives, procedures, and their rights using language that was clear and easy to understand. Participants were explicitly informed of their right to withdraw from the study at any time without penalty. Written informed consent was obtained from all participants prior to inclusion. Outcome measures The primary outcome was postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at four-time points: 6 h, Day 1, Day 3, and Day 7 after surgery, in comparison with preoperative values. The VAS scores range from 0 to 10, with 0 indicating no pain and 10 indicating the most severe pain. Anxiety levels were measured using the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report instrument evaluating symptoms experienced over the past two weeks. Each item is scored on a four-point scale, with total scores ranging from 0 to 21; higher scores indicate more severe anxiety. GAD-7 levels were categorized into five grades: 1 (normal), 2 (mild anxiety), 3 (moderate anxiety), 4 (moderately severe anxiety), and 5 (severe anxiety). Data collection and quality control Participants began listening to their selected music one day prior to surgery. Each participant recorded the daily listening duration and music type. During hospitalization, completed questionnaires were collected promptly by research staff. After discharge, participants were instructed to continue listening to music at home. To enhance adherence and reduce dropout rates, a research assistant contacted each participant daily by phone to document music listening details and assist with questionnaire completion. All collected data were compiled and documented systematically. Quality control measures included the following: (1) strict adherence to inclusion and exclusion criteria by investigators; (2) establishing rapport with participants to ensure cooperation; (3) cross-verification of collected data with patient records; (4) questionnaire design based on literature and the health ecology model, with careful review of content, scoring standards, and item interpretation; investigators provided explanations for items unclear to participants, and all questionnaires were collected and checked on-site; (5) double entry of data, verification by two personnel, and statistical correction of potential confounders during data analysis. A 5% sample of entries was randomly selected for accuracy checks against the original data; (6) all research staff underwent standardized training.

Baseline characteristics A total of 150 patients were initially recruited. One participant withdrew at the start of the study, resulting in 149 patients included in the final analysis. All participants were randomly assigned to groups: 75 to the music intervention group and 74 to the control group (). There were no statistically significant differences between the two groups in terms of baseline characteristics, including age, BMI, marital status, preoperative VAS scores, and preoperative GAD-7 scores and categories (). Primary outcome measures Postoperative pain was assessed using the Visual Analogue Scale (VAS) at 6 h, Day 1, Day 3, and Day 7 after surgery. No statistically significant differences in VAS scores were observed between the two groups at any time. Baseline VAS scores also showed no significant difference. Anxiety was evaluated using the Generalized Anxiety Disorder Scale (GAD-7) on postoperative Day 1, Day 3, and Day 7. No significant differences were found between the groups in GAD-7 scores or anxiety severity levels at any time point. Baseline GAD-7 scores and severity levels were also comparable between the two groups (). Secondary outcomes No adverse reactions were observed among patients receiving music therapy throughout the follow-up period. Postoperative recovery indicators showed no statistically significant differences between the two groups, including the incidence of nausea and vomiting at 2 h, 4 h, 6 h, and on postoperative Day 3. Additionally, the time to first flatus and time to first ambulation, measured in hours as indicators of recovery speed, were comparable between groups without significant differences. Analysis of potential confounding factors, including the presence of DIE, placement of drainage tubes, use of patient-controlled analgesia pumps, administration of analgesics, and frequency of analgesic use, also revealed no statistically significant differences between the groups ().

Anxiety can be defined as an unpleasant emotional response to anticipated stressful events, while stress refers to the physiological reaction to specific situations [Citation18]. Anxiety, stress, and pain are closely interconnected and often influence one another [Citation19]. With the transition toward a more holistic model of modern medicine, increasing attention has been directed toward the psychological well-being of young, nulliparous patients with EMS who desire fertility. In addition to surgical interventions, puncture procedures, and pharmacological treatments, noninvasive, side-effect-free, and cost-effective strategies are needed to alleviate pre- and postoperative anxiety, stress, and pain in this population. Music therapy reduces patient distress by delivering positive auditory stimuli that mask negative sounds, enhance emotional regulation, and evoke feelings of hope and comfort during the treatment process. Its effectiveness has been supported by numerous scientific studies [Citation20–23]. Previous studies have shown that rhythm [Citation24] and genre [Citation25] of music may influence therapeutic outcomes. A large meta-analysis [Citation26] indicated that, although the therapeutic benefit of music may not depend on specific musical styles, allowing patients to choose preferred tracks from a curated playlist significantly enhances postoperative recovery. Based on this finding, the current study enabled participants to select music through the “Cloud Third Affiliated Hospital of Sun Yat-sen University” mini-program. Developed and patented by the Third Affiliated Hospital of Sun Yat-sen University, this platform features an “Emotional Regulation through Music” module that delivers music-based psychological therapy. The module has been shown to improve emotional resilience and reduce psychological burden in diverse populations, including elderly individuals and children, thereby contributing to overall psychosomatic well-being [Citation27]. Baseline analysis in the present study showed no statistically significant differences between the control and music groups in key preoperative indicators, including VAS scores, GAD-7 scores, and anxiety severity levels. Existing research on the prevalence of anxiety in women with EMS undergoing laparoscopic surgery remains limited. Carr et al. [Citation28] reported that the incidence of high anxiety (anxiety score > 45) could reach up to 67% prior to gynecological surgery. In the current study, 59.7% of patients presented with at least mild anxiety before surgery. Binns-Turner et al. found that music reduced anxiety, mean arterial pressure, and pain in women undergoing mastectomy [Citation29]. Kahloul M et al. [Citation30] demonstrated that music therapy effectively alleviated postoperative anxiety and enhanced patient satisfaction. A study by Labrague et al. [Citation31], using a pretest-posttest quasi-experimental design, revealed that women undergoing mixed gynecological procedures experienced significantly lower anxiety, heart rate, and blood pressure after listening to prerecorded music compared to controls. Similarly, research by Casrin et al. [Citation32] showed that music therapy significantly reduced preoperative anxiety in women undergoing laparoscopic hysterectomy for benign conditions. However, the findings of the present study did not align with those results. No significant differences in GAD-7 scores or anxiety severity levels were observed between groups on postoperative Days 1, 3, and 7. This discrepancy may be attributed to persistent anxiety triggers specific to EMS patients, including fertility concerns, fear of disease recurrence, and potential decline in ovarian function following surgery. Pharmacologic analgesics remain an effective method for managing postoperative pain. However, their use is frequently associated with notable adverse effects. Effective control of postoperative pain in EMS patients is critical for improving recovery quality and mitigating stress, anxiety, and depressive symptoms. As a result, non-pharmacological interventions have attracted increasing attention. Jayaraman L et al. [Citation33] evaluated the analgesic effects of music therapy in 111 patients undergoing cholelithiasis surgery and reported significantly higher pain intensity in the non-music group. A large meta-analysis [Citation26] demonstrated that music interventions significantly reduced pain intensity during recovery, consistent with other findings supporting the role of music in postoperative analgesia. However, some studies have yielded conflicting results. For instance, one study [Citation34] found no significant pain relief from light music within 3 h after laparoscopic cholecystectomy. Another investigation [Citation32] reported no reduction in pain intensity at 1, 3, or 6 h postoperatively in patients undergoing laparoscopic total hysterectomy who received music therapy. In the present study, no statistically significant differences in VAS pain scores were observed between the control and music groups at 6 h, Day 1, Day 3, or Day 7 postoperatively. These findings may relate to the minimally invasive nature of laparoscopic procedures for EMS, which are known to cause less postoperative pain than open surgery. Additionally, music therapy may function primarily as an adjunct rather than a replacement for pharmacological treatment. Analgesic effects may only be apparent when baseline pain is well-controlled, allowing patients to benefit from the music they enjoy, thereby enhancing the effectiveness of music as a supplementary analgesic strategy. Effective control of confounding variables is essential to ensure the accuracy and reliability of findings in randomized controlled trials (RCTs). To manage confounders in RCTs, researchers must employ a range of strategies, including the identification and control of potential confounders during the design phase, as well as the application of stratified analysis, multivariable regression, propensity score matching, and sensitivity analyses. These methods help minimize the influence of confounders on outcome measures, thereby improving the validity and precision of results. In the present study, the primary endpoints, VAS scores and anxiety assessments are subject to individual perception and may be influenced by subjective factors. Therefore, efforts were made to identify and control all potential confounders that could impact patient-reported outcomes. Variables likely to affect subjective experiences were recorded, and statistical analysis confirmed no significant differences between groups in these parameters, strengthening the reliability of the primary outcome comparisons. However, several limitations of the present study must be acknowledged. First, the care received by patients in the music intervention group may not fully reflect routine clinical practice. The nature of the trial, such as recruitment procedures, the informed consent process, and the requirement to complete self-reported questionnaires, could not be blinded, potentially introducing performance and detection bias among both healthcare providers and patients. These factors may have influenced outcome assessments and, consequently, the interpretation of results. Second, although attempts were made to identify and control for confounders related to postoperative pain, certain variables, such as the type and dosage of intraoperative anesthetic agents, may still have affected early postoperative pain scores. As a result, statistically nonsignificant differences in pain outcomes may not necessarily reflect the perceived clinical relevance from the patients’ perspective. Music therapy may be considered a complementary approach to relieve pain or anxiety to a certain extent. In the future, studies can be conducted by expanding the sample size, extending the follow-up period, adding more types of music and subgroup stratified analysis to further understand the impact of music therapy.

Music therapy may be considered a complementary approach for young, nulliparous patients with fertility desires undergoing laparoscopic cystectomy for endometriotic ovarian cysts. However, no significant improvements in preoperative or postoperative anxiety or postoperative pain were demonstrated in this population. Ethical approval This study was approved by the Institutional Review Board of the Third Affiliated Hospital of Sun Yat-sen University (Approval NO: II2023-292-01). Authors’ contributions The manuscript was written collaboratively by Wenwei Li and Huiyan Feng. Wenwei Li contributed to the interpretation of the results and analysis of all the data. Huiyan Feng contributed to the computational analysis of all the data. Xiaohui Yang and Yue Meng were responsible for acquisition of data. Qingjian Ye and Yuebo Yang conceived the study, managed the project throughout, critically revised the manuscript, checked all data and analyses and provided financial and human support for the smooth progress of the whole project. All authors critically reviewed and approved the final version of the manuscript. Consent to participate Written informed consent provided prior to enrollment.

We would like to thank the nurses, medical doctors and other staff of the Third Affiliated Hospital of Sun Yat-sen University for their support. Disclosure statement No potential conflict of interest was reported by the author(s). Data availability statement All relevant data are within the paper. Additional information Funding

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