{"paper_id":"57c78b69-f034-45f1-bb9a-7af27462f949","body_text":"1\n1 A quasi-experimental study to compare effectiveness of a breastfeeding arm \n2 sling with normal breastfeeding cross-cradle hold position\n3 Short-Tile: The effectiveness of a newly designed breastfeeding arm sling \n4\n5 Author details:\n6 Pornsri Disorntatiwat 1, Mary Steen2*, Sudjit Liblub1\n7 1 Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol \n8 University, Thailand \n9 2 Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, \n10 University of Northumbria, The United Kingdom\n11\n12 *Corresponding author\n13 E-mail: mary.steen@northumbria.ac.uk\n14\n15 All authors contributed to the study design, data analysis and writing the article.\n16 PD and SL managed the data collection process in Thailand.\n17\n18\n19\n20\n21\n22\n23\n24\n25\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \nNOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.\n\n2\n26\n27\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n3\n1 Abstract\n2 Breastfeeding has many benefits for the newborn and mother therefore, the World \n3 Health Organization guidelines recommend exclusive breastfeeding for the first 6 \n4 months, with continued breastfeeding for up to two years. However, exclusive \n5 breastfeeding rates in the first 6 months in Thailand were reported to be approximately, \n6 14% in 2019. Research has highlighted that many mothers’ have a lack of belief in \n7 their ability to breastfeed, and some physical conditions, such as tiredness and \n8 difficulty continually holding their baby in a comfortable position. Additionally, first-time \n9 breastfeeding can contribute to mothers having difficulties breastfeeding during the \n10 early postnatal period. Therefore, the Arm sling innovation (device) has been designed \n11 to provide support and comfort whilst holding the newborn. This study compared the \n12 effectiveness of the breastfeeding arm sling innovation to support breastfeeding in \n13 cross-cradle hold position and normal cross-cradle hold position breastfeeding in first-\n14 time mothers. A quasi-experimental pretest-posttest research design was used to \n15 evaluate the effectiveness of breastfeeding before and after the intervention among \n16 first-time mothers in the postnatal unit, at Ramathibodi hospital, Thailand. A total of 46 \n17 postpartum mothers participated in the study. The results showed that the \n18 effectiveness of breastfeeding reported by mothers between using a normal cross-\n19 cradle hold position and using breastfeeding arm sling innovation was statistically \n20 significantly different (t = 4.32, P < 0.001) with helping to hold the baby securely without \n21 slipping (t=5.68, p<0.001) and mothers can continue to breastfeed (t=2.09, p <0.001). \n22 Majority of mothers were satisfied with the support of using the breastfeeding arm sling \n23 innovation design. The breastfeeding arm sling innovation contributes to the \n24 effectiveness of breastfeeding by assisting and supporting the mother and baby’s \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n4\n25 position to breastfeed more comfortably, thus assisting first-time mothers to feel \n26 comfortable, confident, and able to continue breastfeeding. \n27\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n5\n28 Introduction\n29 The benefits of breastfeeding for babies are well established as breast milk is \n30 naturally produced, safe, clean, provides complete nutrition, and contains antibodies \n31 that help protect against many common childhood illnesses [1]. Breastfeeding \n32 increases the bonding between a mother and her infant and also self-esteem for \n33 mothers from the experience [1]. Therefore, the World Health Organization has \n34 recommended that infants should be exclusively breastfed for the first six months of \n35 life and to continue breastfeeding for up to two years and beyond [2]. \n36 Despite the many benefits of breastfeeding, rates in Thailand remain low. \n37 World Health Organization guidelines and, also the most recent national report in \n38 Thailand have reported that the six months exclusive breastfeeding rate was \n39 approximately 14% in Thailand in 2019 [3].  According to the Ten Steps to Successful \n40 Breastfeeding, postpartum women should facilitate immediate initiation of \n41 breastfeeding, i.e., within the first hour after birth, and then attempt to breastfeed \n42 every 2–3 hours with a goal of eight sessions per 24-hour period to stimulate \n43 prolactin hormone to increase milk production [2,4]. However, there are a lot of \n44 factors that contribute to inadequate breastfeeding such as maternal discomfort \n45 which is frequently experienced by mothers during the breastfeeding period [5].  \n46 Previous research has found that many mothers have a lack of belief in their ability \n47 to breastfeed, and some physical conditions and tiredness can also contribute to \n48 them having difficulties breastfeeding during the early postnatal period [6]. \n49 Additionally, other problems can contribute to the first-time mothers’ inability to \n50 breastfeed their newborns, and some have reported feeling that they have \n51 insufficient milk and difficulties latching, thus leading to shortening the duration of \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n6\n52 breastfeeding [7]. It is important to note that breastfeeding experiences can vary \n53 considerably between first-time and previously breastfed mothers [8]. \n54 Positioning of the baby's body and correct latching on of the baby is essential \n55 for good attachment and successful breastfeeding [9].  A cross-cradle hold position \n56 helps to guide the baby’s head and mouth while feeding and can help to avoid poor \n57 latching, which can cause nipple redness and/or cracking [10]. It has been reported \n58 that this position is preferred by new mothers who have little experience regarding \n59 breastfeeding or for babies who have not learned how to latch on the breast well \n60 [11]. Therefore, the midwife’s role involves helping mothers and providing support, \n61 such as guidance and counseling on practical concerns like breastfeeding positions \n62 and how to make mothers feel comfortable and thus promote longer duration of \n63 breastfeeding [12]. Signs that a baby is well attached during breastfeeding include \n64 holding the baby so that their face touches the mother’s breast, their head and body \n65 in alignment with the mother’s breast, their mouth wide open, and more of the areola \n66 is visible above the baby's top lip than below the lower lip, as according to the four \n67 key signs for effective breastfeeding [2]. However, all these signs can lead to a \n68 mother feeling over-tired and can make her wrist and arm become uncomfortable \n69 and cause an aching sensation during breastfeeding.  \n70 Currently, there are several aids to help mothers breastfeed, for example, a \n71 functional nursing bra and a specifically designed supporting pillow; these aids can \n72 help mothers to continue breastfeeding. However, local new mothers have \n73 expressed how they find it difficult to continually hold their baby in a comfortable \n74 position and that their arm often aches during breastfeeding. The mothers’ \n75 experiences have been observed by the midwifery researchers and issues during \n76 breastfeeding such as, incorrect feeding position, extreme tiredness, and wrist pain \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n7\n77 have been identified whilst working in the postnatal unit at the local hospital \n78 (Ramathibodi Hospital). Therefore, there is a justification to find new ways to help \n79 and support first-time mothers to breastfeed comfortably and reduce the risk of wrist \n80 and arm pain as well as increase self-esteem for the mothers who choose to \n81 breastfeed.\n82 Definition of the methods of breastfeeding position\n83 - Normal breastfeeding position is a normal cross-cradle hold position breastfeeding \n84 with a pillow support \n85 - Breastfeeding arm sling innovation is the intervention to attach the mother’s arm \n86 whilst holding her baby to breastfeed in a cross-cradle hold position with a pillow \n87 support  \n88 Aim and Objectives \n89 - To compare the effectiveness of the breastfeeding arm sling innovation to support \n90 breastfeeding in cross-cradle hold position and normal cross-cradle hold position \n91 breastfeeding in first-time mothers. \n92 - To evaluate the satisfaction with the breastfeeding arm sling innovation to \n93 support breastfeeding in cross-cradle hold position in first-time mothers \n94 The null hypothesis was that there is no difference in the mean scores for the \n95 effectiveness of breastfeeding between using breastfeeding arm sling innovation \n96 and breastfeeding in normal cross-cradle hold position.\n97 Materials and Methods\n98 A quasi-experimental pretest-posttest research design was used to evaluate \n99 scores on the effectiveness of breastfeeding before and after using the breastfeeding \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n8\n100 arm sling innovation. This study design was chosen to undertake a comparison of \n101 the scores after an intervention to scores on the same measure in the same \n102 participants prior to the intervention [12]. Firstly, researchers designed and \n103 developed the breastfeeding arm sling innovation and conducted a pilot test of the \n104 innovation. Secondly, the researchers explained study information in a step-by-step \n105 approach guided by a research protocol and specific requirements of assessment to \n106 midwives (research assistants) for approximately, 30-60 minutes. The midwives \n107 demonstrated how they would undertake an assessment to confirm correct \n108 procedure. \n109 Mothers who meet the inclusion criteria were invited to participate in the \n110 study. Mothers were informed about the purpose of the study and given an \n111 opportunity to discuss the study to make an informed choice to participate. Mothers \n112 were asked to complete a written consent form.  \n113 The experiment involved two stages (Fig 1). In the first stage, mothers were \n114 selected to provide 15 minutes of breastfeeding by using a cross-cradle hold position \n115 with the breastfeeding arm sling innovation or a normal cross-cradle hold position. \n116 As it is a clinical practice to wrap a baby (swaddle) to prevent hypothermia in the \n117 newborn in the postnatal unit at the study hospital [13-14], the babies in this \n118 experiment were wrapped in both groups (using a cross-cradle hold position with the \n119 breastfeeding arm sling innovation or a normal cross-cradle hold position), see Fig 1. \n120 Fig. 1. This is the Fig 1 Title. The experimental flowchart. \n121 In the case of breastfeeding with a normal cross-cradle hold position, the \n122 midwives (research assistants) helped the mother to provide 15 minute-\n123 breastfeeding. The midwives (research assistants) observed and measured the \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n9\n124 effects of breastfeeding. In the case of breastfeeding with a cross-cradle hold \n125 position with the breastfeeding arm sling innovation, the midwives (research \n126 assistants) helped the mother to wear the sheath of the breastfeeding arm sling \n127 innovation and wrap the equipment around the baby. When the baby was latched on \n128 the midwives helped the mother to adhere the equipment for a firm hold. Following \n129 this, the mother provided 15-minute breastfeeding. The midwives observed and \n130 measured the effectiveness of breastfeeding. After breastfeeding, mothers were \n131 asked to complete the effectiveness of breastfeeding and satisfaction of using \n132 breastfeeding arm sling innovation questionnaires.  \n133 The following stage was undertaken three hours later, and 15-minute-\n134 breastfeeding was repeated (normal cross-cradle hold position or breastfeeding arm \n135 sling innovation with cross-cradle hold position) follow-up on the effectiveness of \n136 breastfeeding and satisfaction levels outcomes were assessed.\n137 Participants and setting\n138 This study was conducted in the postnatal unit, at Ramathibodi hospital, \n139 Thailand. Two hours after giving birth, mothers were transferred to the postnatal unit \n140 and provided with care and support. It is normal practice for healthy mothers and \n141 their newborn babies to be discharged home from the postnatal unit within 48-72 \n142 hours. In this unit, assistance with breastfeeding during the postpartum period is \n143 provided by nurse-midwives. Research assistants, thus, are nurse-midwives who are \n144 healthcare providers in the postnatal unit, having knowledge of assessing and \n145 observing breastfeeding behaviour. Breastfeeding assistance can vary according to \n146 the nurse-midwife that provides the care. Therefore, during the undertaking of this \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n10\n147 study, the nurse-midwife who supported a mother to breastfeed continued to be the \n148 same person, in order to control for any breastfeeding effect. \n149 The structured questionnaire \n150 The effectiveness of breastfeeding was recorded by a questionnaire for \n151 participants and midwife assessors that was modified from the four-key points (The \n152 Breastfeed Observation), which aligned with the key signs to effective breastfeeding. \n153 Questions were related to the four key points of the baby’s position: baby’s head and \n154 body in line, baby held close to mother’s body, baby faces the breast with nose \n155 opposite the nipple, baby’s whole body supported [2].   \n156 Additionally, observations relating to good attachment: more areola seen above \n157 baby’s top lip, baby’s mouth open wide, lower lop turned outwards and baby’s chin \n158 touches breast  were considered. The participants self-reported these effective \n159 breastfeeding signs, and the midwives observed these signs. Both questionnaires \n160 included five items that utilised a ranked 5-point Likert-type scale to assess the \n161 effectiveness of breastfeeding outcomes.  \n162 The breastfeeding arm sling innovation satisfaction questionnaire was \n163 developed by the researchers and adapted from the diffusion of innovation model, \n164 which demonstrates innovation is generally adopted when four relative advantages \n165 are considered i.e., compatibility, complexity, trial-ability, and observability [15]. The \n166 questionnaire includes 14 items ranked on a 5-point scale from lowest satisfaction to \n167 the highest level of satisfaction. The face and content validity were tested through \n168 consultation with a panel of three experts, including maternal-newborn and midwifery \n169 experienced researchers from the Ramathibodi School of Nursing, Mahidol University. \n170 The structure of the questionnaire also included open-ended questions and sought \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n11\n171 qualitative information regarding using the breastfeeding arm sling innovation to \n172 explore what participants views were and report their thoughts in their own words [16].\n173 Sample size calculation \n174 The sample size was calculated based on a pilot study involving 5 mothers that \n175 were undertaken in the same setting to test the study feasibility (SD. = 1.2). According \n176 to the formula to calculate the sample size, considering an alpha error of 0.05, Delta \n177 0.5, and a test power of 80%, under one tail hypothesis, the sample size of 46 mothers \n178 was required to participate [17]. \n179 Data collection \n180 Recruitment and data collection were undertaken in the postnatal unit on a daily \n181 basis, by a research assistant, who recruited participants and implemented the \n182 assignment of the intervention. A midwife (research assistant) supported and advised \n183 a mother how to breastfeed using the cross-cradle holding position and how to use the \n184 breastfeeding arm sling innovation. The mothers who met the inclusion criteria were \n185 asked to assess their breastfeeding effectiveness before the intervention. After the \n186 breastfeeding intervention (15 minutes), the mothers were asked to assess their \n187 breastfeeding effectiveness and measure self-reported satisfaction. The midwives \n188 (research assistants) observed and completed the effectiveness of the breastfeeding \n189 questionnaire in both normal breastfeeding and during the intervention. \n190 Intervention \n191 The breastfeeding arm sling innovation has been designed and tailored by \n192 using spandex for the sleeves, filled with elastic and attached with 6 cm leather, see \n193 Fig. 2. The spandex used for both arm wear is 5.0 cm. apart and has two straps that \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n12\n194 are 63 x 7.5 cm. Both ends of the spandex are attached to Velcro straps in two \n195 positions to allow adjustment of the size according to the baby's size. \n196  Fig 2. This is the Fig 2 Title. Breastfeeding arm sling innovation\n197 In the first step of applying the support equipment, the midwives (research \n198 assistants) helped the mother to wear the sheath of the breastfeeding arm sling \n199 innovation and wrap the equipment around the baby. When the baby was latched on \n200 and feeding, the midwives (research assistants) helped the mother to adhere the \n201 equipment for a firm hold, so that the mother's arm touched closely the baby's back to \n202 support breastfeeding. This technique helped the mother's arm to touch the baby's \n203 back, therefore enabling her to hold the newborn baby closer. An advantage of this \n204 approach is that it prevents fatigue of the wrists and shoulders of the mothers during \n205 breastfeeding. \n206 As this research is in the experimental stage, a helper was required to support \n207 how to apply the breastfeeding arm sling innovation. This initial help to use the \n208 breastfeeding arm sling innovation showed mothers how to apply and use the \n209 breastfeeding arm sling by themselves for further breastfeeding (Fig 2).\n210 Statistical analysis\n211\n212 All data analysis was performed using the IBM SPSS Statistics 27.0.1.0 \n213 software package [18]. Data were expressed as means and standard deviations (SD). \n214 A comparison of the means of the two groups within subjects was evaluated for \n215 significance using paired t-tests. A p-value of less than 0.05 was considered \n216 significant.\n217 Ethical considerations\n218\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n13\n219 The study was approved by the Ethics Committee on Human Subjects of the \n220 Faculty of Medicine at Ramathibodi Hospital, Mahidol University, Thailand (IRB COA. \n221 MURA2021/949), in line with the Human Research Protection such as Declaration of \n222 Helsinki, The Belmont Report, and the International Conference on Harmonization in \n223 Good Clinical Practice (ICH-GCP).\n224 Results\n225 Participants’ demographic characteristics\n226 A total of 46 postpartum women participated in the study ranging in age from \n227 19 to 40 years with a mean age of 29 years (SD = 5.65). Gestational age ranged from \n228 37-41 weeks (mean gestational age 38 weeks, SD = 1.09 weeks). Mothers who \n229 participated in the study were post-birth on their first day n = 18 (54.5 %), second day \n230 n= 9 (27.3 %), and third day n=6 (18.2%). The babies of the participants had a mean \n231 weight of 3151 grams. \n232 Differences in the effectiveness of breastfeeding observed \n233 by mothers between groups \n234 The results of paired t-tests showed that the effectiveness of breastfeeding \n235 reported by mothers between using a normal cross-cradle hold position and using a \n236 cross-cradle hold position with breastfeeding arm sling innovation was statistically \n237 significantly different (t = 4.32, P < 0.001). The difference in total scores of using \n238 breastfeeding arm sling innovation and normal breastfeeding was statistically \n239 significant (hold the baby securely without slipping: t=5.68, p<0.001; feeling no pain at \n240 the nipples while the baby is suckling: t=4.76, p <0.001; baby can continue to suck: \n241 (t=2.09, p <0.001); baby held close to mother’s body: t=5.76, p <0.001; No pain felt at \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n14\n242 the breast during sitting to breastfeed continuously: t=4.24, p <0.001),  as presented \n243 in table 1.\n244 Table 1. Comparison of the effectiveness of breastfeeding between using \n245 normal cross-cradle hold position and using cross-cradle hold position with \n246 breastfeeding arm sling innovation by mothers\nUsing \nbreastfeeding \narm sling \ninnovation \nequipment\nNormal \nbreastfeeding\nEffectiveness of breastfeeding\nMEAN SD MEAN SD\nt p-value\n1. Hold the baby tightly without \nslipping\n3.24 0.67 2.20 1.02 5.68 <0.001\n2. The feeling of no pain at the \nnipples while the baby is suckling\n2.63 0.74 2.04 0.89 4.76 <0.001\n3. Baby can continue to suck 3.02 0.86 2.33 0.97 2.09 <0.001\n4. Baby held close to mother’s \nbody\n3.28 0.78 2.24 1.08 5.76 <0.001\n5. No pain felt at the breast \nduring sitting to breastfeed \ncontinuously\n2.65 0.77 1.96 0.89 4.24 <0.001\nTotal 2.97 0.60 2.15 0.80 4.32 <0.001\n247\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n15\n248 Differences in the effectiveness of breastfeeding observed \n249 by midwives between groups \n250 Table 2 shows the effectiveness of breastfeeding observed by the midwife \n251 and indicates a significant difference in the effects of signs of baby attached during \n252 breastfeeding between normal breastfeeding and using breastfeeding arm sling \n253 innovation in all outcomes.  Compared with normal breastfeeding, using \n254 breastfeeding arm sling innovation increased significantly as greater areola seen \n255 above the baby’s top lip (t = 6.03, p <0.001); baby’s chin touches breast (t = 6.26, p \n256 <0.001); baby’s head and body in line (t = 7.46, p <0.001); baby’s mouth open wide \n257 (t = 6.49, p <0.001); baby’s cheeks do not dimple during breastfeed (t = 7.29, p \n258 <0.001).\n259 Table 2. Comparison of the effectiveness of breastfeeding between using \n260 normal cross-cradle hold position and using cross-cradle hold position with \n261 breastfeeding arm sling innovation by midwife (researcher assistance)\nUsing \nbreastfeeding arm \nsling innovation \nequipment\nNormal \nbreastfeeding\nEffectiveness of \nbreastfeeding \nMEAN SD MEAN SD\nt p-value\n1. More areola seen above \nbaby’s top lip\n2.93 0.77 2.22 0.59 6.03 <0.001\n2. Baby’s chin touches breast 3.08 0.66 2.34 0.71 6.26 <0.001\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n16\n3. Baby’s head and body in \nline\n3.24 0.77 2.04 0.87 7.46 <0.001\n4. Baby’s mouth open wide 3.24 0.82 2.37 0.77 6.49 <0.001\n5. Baby’s cheeks do not \ndimple during breastfeeding\n3.30 0.76 2.48 0.72 7.29 <0.001\nTotal 3.16 0.64 2.29 0.59 8.93 <0.001\n262\n263 Mothers’ satisfaction using breastfeeding arm sling \n264 innovation\n265 The majority of the mothers were satisfied with the suitability of using the \n266 breastfeeding arm sling innovation design (52.9%, size and length 44.1% and fabric \n267 used 41.2%). While half (50%) of the mothers were satisfied with the appearance of \n268 the breastfeeding arm sling innovation, (41.2%) reported that they were very satisfied \n269 with the non-slippage. Meanwhile, satisfied level of the features of easy to use \n270 (41.2%), ease of disassembly (41.2%), and ease of cleaning (38.2%) were reported \n271 by the mothers (Table 3).\n272 Table 3. Mothers’ satisfaction using breastfeeding arm sling innovation\nSatisfaction levels (%)How satisfied are you with using \nthe breastfeeding arm sling \ninnovation\nVery \nSatisfied\nSatisfied Neutral Unsatisfied\nVery \nUnsatisfied\nEasy-to-use features\n1) Easy to use 17.6 41.2 35.3 2.9 2.9\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n17\n2)Non slippage 41.2 41.2 17.6\n3)Easy to disassemble 5.9 41.2 41.2 11.8\n4)Easy to clean 38.2 38.2 23.5\nSuitability of equipment\n5)Design 14.7 52.9 29.4 2.9\n6) Size and length 26.5 44.1 26.5 2.9\n7) Beauty 11.8 50.0 35.3 2.9\n8) Fabric used 32.4 41.2 23.5 2.9\nTrial-ability\n9)The ability to hold a baby to \nbreastfeed\n35.3 41.2 17.6 5.9\n10)Ease of carrying a baby 35.3 41.2 17.2 5.9\n11)Pain in the arm while holding \nthe baby\n35.3 29.4 23.5 11.8\n12)Tension in the wrist while \nholding the baby\n20.6 44.1 26.5 8.8\nObservability\n13)Satisfaction with the use of the \ninnovation for breastfeeding \n32.4 38.2 23.5 5.9\n14)Feelings of Confidence in \nBreastfeeding\n38.2 35.3 20.6 5.9\n273\n274 Regarding the trial-ability, (44.1%) of mothers reported the breastfeeding arm sling \n275 innovation helped to reduce tension in the wrist while holding the baby. Mothers \n276 reported that they were satisfied with their ability to hold their baby to breastfeed \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n18\n277 (41.2%) and ease of carrying baby (41.2%). Overall, (32.4%) of mothers felt very \n278 satisfied with the use of breastfeeding arm sling innovation and (38.2%) reported \n279 feeling confident in breastfeeding.\n280 Discussion\n281 The development of innovations model is a new concept in the nursing and \n282 midwifery process for developing, improving, and adapting products or procedures to \n283 significantly benefit outcomes [10]. Results of the present study show the clinical \n284 usefulness of the breastfeeding arm sling innovation in supporting breastfeeding. The \n285 findings from this current study showed that mothers and midwives reported the \n286 effectiveness of breastfeeding between using a normal cross-cradle hold position and \n287 using a cross-cradle hold position with breastfeeding arm sling innovation was \n288 statistically significantly different in all-term supports (t= 4.32, p <0.001) included \n289 holding the baby so that their face touched the mother’s breast, their head and body \n290 was in alignment with their mother’s breast, mouth wide open, and more of the areola \n291 was visible above the baby's top lip than below the lower lip. These findings are in \n292 accordance with Rahim et al. study, who emphasised success of the breastfeeding \n293 process depends on the accuracy of the position and attachment of the baby to the \n294 mother’s breast and the ability of the baby to suck [19].\n295 For a good attachment and effective breastfeeding, the baby's body positioning and \n296 latching technique are crucial [9]. Improper latch and inappropriate infant positioning \n297 can cause nipple pain and trauma [20]. Results from this current study demonstrate \n298 that the breastfeeding arm sling innovation helped mothers to breastfeed and \n299 decreased the feeling of pain at the nipples while the baby was latched on and feeding. \n300 This significant improvement in comfort helped to encourage continued breastfeeding. \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n19\n301 The use of an innovative breastfeeding arm sling helped the mothers who participated \n302 in this study to hold the baby’s body without any slipping during breastfeeding so that \n303 the baby’s mouth and head were in a position in alignment with the nipple. Correct \n304 positioning and attachment of newborns during breastfeeding was one of the \n305 recommendations by Kent et al. [21], to help reduce nipple pain, increase the duration \n306 of breastfeeding, and reduce breastfeeding problems.\n307 Breastfeeding can be challenging for first-time mothers who have little experience of \n308 breastfeeding and newborns who have not yet learned how to properly latch on to the \n309 breast [11]. The current study’s results show that the breastfeeding arm sling \n310 innovation helped mothers feel less pain in the arm while holding the baby and sitting \n311 to breastfeed continuously. The study's findings are consistent with previous research \n312 demonstrating that innovations can address patient demands or help solve problems, \n313 leading to better outcomes for patients [10]. The first-time mothers in this study valued \n314 the breastfeeding arm sling innovation and felt very satisfied as it helped them feel \n315 comfortable during breastfeeding. This may be due to the breastfeeding arm sling \n316 innovation fitting the mother's arm to promote a correct position and enabling her to \n317 touch the newborn baby's back so that she can hold her baby closer during \n318 breastfeeding. Given the appropriate posture during breastfeeding, the breastfeeding \n319 arm sling innovation is considered acceptable among first-time mothers, with most \n320 mothers using it and reporting more confidence in breastfeeding.\n321 The breastfeeding arm sling innovation was reported to have very satisfactory features \n322 due to its non-slipping benefit. With the features of easy to use and disassemble, \n323 however, this breastfeeding arm sling innovation required assistance to help mothers \n324 apply the equipment, wrapping it around the baby in order to support the correct \n325 position when the baby was breastfeeding. Self-application needs to be factored in \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n20\n326 when considering the development of the breastfeeding arm sling innovation in the \n327 future to help mothers breastfeed independently.\n328 A strength of this study is that mothers were very willing to participate in the \n329 study and this is also reflected in the high levels of satisfaction reported. Midwife \n330 assessors had preparatory training to assist mothers who agreed to participate. \n331 However, the assessors were known to the mothers, and this may have influenced \n332 their views and experiences positively or negatively as continuity of care is beneficial \n333 but may also have an impact on outcomes. The quasi-experimental study design \n334 allowed the participants to be their own control group, but findings are self-reported \n335 and must be viewed cautiously. The research study used a non-randomised design, \n336 therefore, other confounding factors not controlled for may have influenced the \n337 findings and therefore this limits the inference of the research results. Another \n338 limitation concerning this study was that it was limited to only first-time mothers, which \n339 makes it difficult to generalise the findings to other groups of childbearing women. \n340 Since the breastfeeding arm sling innovation in the present study applies to term \n341 newborn babies, future development would need to consider investigation as to \n342 whether preterm and differences in the baby weights would achieve similar results as \n343 reported in the present study.\n344  Conclusions\n345 The development of innovations model in nursing is a new concept in the \n346 nursing process for developing, improving, or adapting products or procedures to \n347 significantly benefit outcomes and respond directly to patient needs. The \n348 breastfeeding arm sling breastfeeding innovation contributes to the effectiveness of \n349 breastfeeding by assisting and supporting the mother and baby’s position to \n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n21\n350 breastfeed more comfortably. In conclusion, this study provides emerging evidence \n351 that the breastfeeding arm sling assisted first-time mothers to feel comfortable, \n352 confident, and helped them to continue breastfeeding. However, further research is \n353 required to confirm or refute these initial findings.\n354 Acknowledgments\n355 The authors would like to gratefully thank the Faculty of Medicine, Ramathibodi \n356 Hospital, Mahidol University for their support grant and all the participants who took \n357 part in the present study.\n358 Funding Sources:  Ramathibodi School of Nursing Funds, Faculty of \n359 Medicine, Ramathibodi Hospital, Mahidol University, Thailand\n360 References \n361 1. World Health Organization [Internet]. Breastfeeding. [cited 2021 August 23]. \n362 Available from: https://www.who.int/health topics/breastfeeding.\n363 2. World Health Organization [Internet]. Infant and young child feeding: Model \n364 Chapter for Textbooks. c2009 - [cited 2021 August 23]. Available: http: // \n365 www.who.int/inf.htm.\n366 3. National Statistical Office Thailand [Internet]. Summary of Key Indicators June \n367 2020. c2019- [cited 2021 August 23]. 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Principles for maintaining or increasing breast \n414 milk production. Journal of Obstetric, Gynecologic & Neonatal Nursing. \n415 2012;41(1):114-21.\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \nperpetuity. \n is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint \nThe copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint","source_license":"CC-BY-4.0","license_restricted":false}