A quasi-experimental study to compare effectiveness of a breastfeeding arm sling with normal breastfeeding cross-cradle hold position

1 1 A quasi-experimental study to compare effectiveness of a breastfeeding arm 2 sling with normal breastfeeding cross-cradle hold position 3 Short-Tile: The effectiveness of a newly designed breastfeeding arm sling 4 5 Author details: 6 Pornsri Disorntatiwat 1, Mary Steen2*, Sudjit Liblub1 7 1 Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol 8 University, Thailand 9 2 Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, 10 University of Northumbria, The United Kingdom 11 12 *Corresponding author 13 E-mail: [email protected] 14 15 All authors contributed to the study design, data analysis and writing the article. 16 PD and SL managed the data collection process in Thailand. 17 18 19 20 21 22 23 24 25 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. 2 26 27 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 3 1 Abstract 2 Breastfeeding has many benefits for the newborn and mother therefore, the World 3 Health Organization guidelines recommend exclusive breastfeeding for the first 6 4 months, with continued breastfeeding for up to two years. However, exclusive 5 breastfeeding rates in the first 6 months in Thailand were reported to be approximately, 6 14% in 2019. Research has highlighted that many mothers’ have a lack of belief in 7 their ability to breastfeed, and some physical conditions, such as tiredness and 8 difficulty continually holding their baby in a comfortable position. Additionally, first-time 9 breastfeeding can contribute to mothers having difficulties breastfeeding during the 10 early postnatal period. Therefore, the Arm sling innovation (device) has been designed 11 to provide support and comfort whilst holding the newborn. This study compared the 12 effectiveness of the breastfeeding arm sling innovation to support breastfeeding in 13 cross-cradle hold position and normal cross-cradle hold position breastfeeding in first- 14 time mothers. A quasi-experimental pretest-posttest research design was used to 15 evaluate the effectiveness of breastfeeding before and after the intervention among 16 first-time mothers in the postnatal unit, at Ramathibodi hospital, Thailand. A total of 46 17 postpartum mothers participated in the study. The results showed that the 18 effectiveness of breastfeeding reported by mothers between using a normal cross- 19 cradle hold position and using breastfeeding arm sling innovation was statistically 20 significantly different (t = 4.32, P < 0.001) with helping to hold the baby securely without 21 slipping (t=5.68, p<0.001) and mothers can continue to breastfeed (t=2.09, p <0.001). 22 Majority of mothers were satisfied with the support of using the breastfeeding arm sling 23 innovation design. The breastfeeding arm sling innovation contributes to the 24 effectiveness of breastfeeding by assisting and supporting the mother and baby’s . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 4 25 position to breastfeed more comfortably, thus assisting first-time mothers to feel 26 comfortable, confident, and able to continue breastfeeding. 27 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 5 28 Introduction 29 The benefits of breastfeeding for babies are well established as breast milk is 30 naturally produced, safe, clean, provides complete nutrition, and contains antibodies 31 that help protect against many common childhood illnesses [1]. Breastfeeding 32 increases the bonding between a mother and her infant and also self-esteem for 33 mothers from the experience [1]. Therefore, the World Health Organization has 34 recommended that infants should be exclusively breastfed for the first six months of 35 life and to continue breastfeeding for up to two years and beyond [2]. 36 Despite the many benefits of breastfeeding, rates in Thailand remain low. 37 World Health Organization guidelines and, also the most recent national report in 38 Thailand have reported that the six months exclusive breastfeeding rate was 39 approximately 14% in Thailand in 2019 [3]. According to the Ten Steps to Successful 40 Breastfeeding, postpartum women should facilitate immediate initiation of 41 breastfeeding, i.e., within the first hour after birth, and then attempt to breastfeed 42 every 2–3 hours with a goal of eight sessions per 24-hour period to stimulate 43 prolactin hormone to increase milk production [2,4]. However, there are a lot of 44 factors that contribute to inadequate breastfeeding such as maternal discomfort 45 which is frequently experienced by mothers during the breastfeeding period [5]. 46 Previous research has found that many mothers have a lack of belief in their ability 47 to breastfeed, and some physical conditions and tiredness can also contribute to 48 them having difficulties breastfeeding during the early postnatal period [6]. 49 Additionally, other problems can contribute to the first-time mothers’ inability to 50 breastfeed their newborns, and some have reported feeling that they have 51 insufficient milk and difficulties latching, thus leading to shortening the duration of . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 6 52 breastfeeding [7]. It is important to note that breastfeeding experiences can vary 53 considerably between first-time and previously breastfed mothers [8]. 54 Positioning of the baby's body and correct latching on of the baby is essential 55 for good attachment and successful breastfeeding [9]. A cross-cradle hold position 56 helps to guide the baby’s head and mouth while feeding and can help to avoid poor 57 latching, which can cause nipple redness and/or cracking [10]. It has been reported 58 that this position is preferred by new mothers who have little experience regarding 59 breastfeeding or for babies who have not learned how to latch on the breast well 60 [11]. Therefore, the midwife’s role involves helping mothers and providing support, 61 such as guidance and counseling on practical concerns like breastfeeding positions 62 and how to make mothers feel comfortable and thus promote longer duration of 63 breastfeeding [12]. Signs that a baby is well attached during breastfeeding include 64 holding the baby so that their face touches the mother’s breast, their head and body 65 in alignment with the mother’s breast, their mouth wide open, and more of the areola 66 is visible above the baby's top lip than below the lower lip, as according to the four 67 key signs for effective breastfeeding [2]. However, all these signs can lead to a 68 mother feeling over-tired and can make her wrist and arm become uncomfortable 69 and cause an aching sensation during breastfeeding. 70 Currently, there are several aids to help mothers breastfeed, for example, a 71 functional nursing bra and a specifically designed supporting pillow; these aids can 72 help mothers to continue breastfeeding. However, local new mothers have 73 expressed how they find it difficult to continually hold their baby in a comfortable 74 position and that their arm often aches during breastfeeding. The mothers’ 75 experiences have been observed by the midwifery researchers and issues during 76 breastfeeding such as, incorrect feeding position, extreme tiredness, and wrist pain . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 7 77 have been identified whilst working in the postnatal unit at the local hospital 78 (Ramathibodi Hospital). Therefore, there is a justification to find new ways to help 79 and support first-time mothers to breastfeed comfortably and reduce the risk of wrist 80 and arm pain as well as increase self-esteem for the mothers who choose to 81 breastfeed. 82 Definition of the methods of breastfeeding position 83 - Normal breastfeeding position is a normal cross-cradle hold position breastfeeding 84 with a pillow support 85 - Breastfeeding arm sling innovation is the intervention to attach the mother’s arm 86 whilst holding her baby to breastfeed in a cross-cradle hold position with a pillow 87 support 88 Aim and Objectives 89 - To compare the effectiveness of the breastfeeding arm sling innovation to support 90 breastfeeding in cross-cradle hold position and normal cross-cradle hold position 91 breastfeeding in first-time mothers. 92 - To evaluate the satisfaction with the breastfeeding arm sling innovation to 93 support breastfeeding in cross-cradle hold position in first-time mothers 94 The null hypothesis was that there is no difference in the mean scores for the 95 effectiveness of breastfeeding between using breastfeeding arm sling innovation 96 and breastfeeding in normal cross-cradle hold position. 97 Materials and Methods 98 A quasi-experimental pretest-posttest research design was used to evaluate 99 scores on the effectiveness of breastfeeding before and after using the breastfeeding . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 8 100 arm sling innovation. This study design was chosen to undertake a comparison of 101 the scores after an intervention to scores on the same measure in the same 102 participants prior to the intervention [12]. Firstly, researchers designed and 103 developed the breastfeeding arm sling innovation and conducted a pilot test of the 104 innovation. Secondly, the researchers explained study information in a step-by-step 105 approach guided by a research protocol and specific requirements of assessment to 106 midwives (research assistants) for approximately, 30-60 minutes. The midwives 107 demonstrated how they would undertake an assessment to confirm correct 108 procedure. 109 Mothers who meet the inclusion criteria were invited to participate in the 110 study. Mothers were informed about the purpose of the study and given an 111 opportunity to discuss the study to make an informed choice to participate. Mothers 112 were asked to complete a written consent form. 113 The experiment involved two stages (Fig 1). In the first stage, mothers were 114 selected to provide 15 minutes of breastfeeding by using a cross-cradle hold position 115 with the breastfeeding arm sling innovation or a normal cross-cradle hold position. 116 As it is a clinical practice to wrap a baby (swaddle) to prevent hypothermia in the 117 newborn in the postnatal unit at the study hospital [13-14], the babies in this 118 experiment were wrapped in both groups (using a cross-cradle hold position with the 119 breastfeeding arm sling innovation or a normal cross-cradle hold position), see Fig 1. 120 Fig. 1. This is the Fig 1 Title. The experimental flowchart. 121 In the case of breastfeeding with a normal cross-cradle hold position, the 122 midwives (research assistants) helped the mother to provide 15 minute- 123 breastfeeding. The midwives (research assistants) observed and measured the . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 9 124 effects of breastfeeding. In the case of breastfeeding with a cross-cradle hold 125 position with the breastfeeding arm sling innovation, the midwives (research 126 assistants) helped the mother to wear the sheath of the breastfeeding arm sling 127 innovation and wrap the equipment around the baby. When the baby was latched on 128 the midwives helped the mother to adhere the equipment for a firm hold. Following 129 this, the mother provided 15-minute breastfeeding. The midwives observed and 130 measured the effectiveness of breastfeeding. After breastfeeding, mothers were 131 asked to complete the effectiveness of breastfeeding and satisfaction of using 132 breastfeeding arm sling innovation questionnaires. 133 The following stage was undertaken three hours later, and 15-minute- 134 breastfeeding was repeated (normal cross-cradle hold position or breastfeeding arm 135 sling innovation with cross-cradle hold position) follow-up on the effectiveness of 136 breastfeeding and satisfaction levels outcomes were assessed. 137 Participants and setting 138 This study was conducted in the postnatal unit, at Ramathibodi hospital, 139 Thailand. Two hours after giving birth, mothers were transferred to the postnatal unit 140 and provided with care and support. It is normal practice for healthy mothers and 141 their newborn babies to be discharged home from the postnatal unit within 48-72 142 hours. In this unit, assistance with breastfeeding during the postpartum period is 143 provided by nurse-midwives. Research assistants, thus, are nurse-midwives who are 144 healthcare providers in the postnatal unit, having knowledge of assessing and 145 observing breastfeeding behaviour. Breastfeeding assistance can vary according to 146 the nurse-midwife that provides the care. Therefore, during the undertaking of this . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 10 147 study, the nurse-midwife who supported a mother to breastfeed continued to be the 148 same person, in order to control for any breastfeeding effect. 149 The structured questionnaire 150 The effectiveness of breastfeeding was recorded by a questionnaire for 151 participants and midwife assessors that was modified from the four-key points (The 152 Breastfeed Observation), which aligned with the key signs to effective breastfeeding. 153 Questions were related to the four key points of the baby’s position: baby’s head and 154 body in line, baby held close to mother’s body, baby faces the breast with nose 155 opposite the nipple, baby’s whole body supported [2]. 156 Additionally, observations relating to good attachment: more areola seen above 157 baby’s top lip, baby’s mouth open wide, lower lop turned outwards and baby’s chin 158 touches breast were considered. The participants self-reported these effective 159 breastfeeding signs, and the midwives observed these signs. Both questionnaires 160 included five items that utilised a ranked 5-point Likert-type scale to assess the 161 effectiveness of breastfeeding outcomes. 162 The breastfeeding arm sling innovation satisfaction questionnaire was 163 developed by the researchers and adapted from the diffusion of innovation model, 164 which demonstrates innovation is generally adopted when four relative advantages 165 are considered i.e., compatibility, complexity, trial-ability, and observability [15]. The 166 questionnaire includes 14 items ranked on a 5-point scale from lowest satisfaction to 167 the highest level of satisfaction. The face and content validity were tested through 168 consultation with a panel of three experts, including maternal-newborn and midwifery 169 experienced researchers from the Ramathibodi School of Nursing, Mahidol University. 170 The structure of the questionnaire also included open-ended questions and sought . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 11 171 qualitative information regarding using the breastfeeding arm sling innovation to 172 explore what participants views were and report their thoughts in their own words [16]. 173 Sample size calculation 174 The sample size was calculated based on a pilot study involving 5 mothers that 175 were undertaken in the same setting to test the study feasibility (SD. = 1.2). According 176 to the formula to calculate the sample size, considering an alpha error of 0.05, Delta 177 0.5, and a test power of 80%, under one tail hypothesis, the sample size of 46 mothers 178 was required to participate [17]. 179 Data collection 180 Recruitment and data collection were undertaken in the postnatal unit on a daily 181 basis, by a research assistant, who recruited participants and implemented the 182 assignment of the intervention. A midwife (research assistant) supported and advised 183 a mother how to breastfeed using the cross-cradle holding position and how to use the 184 breastfeeding arm sling innovation. The mothers who met the inclusion criteria were 185 asked to assess their breastfeeding effectiveness before the intervention. After the 186 breastfeeding intervention (15 minutes), the mothers were asked to assess their 187 breastfeeding effectiveness and measure self-reported satisfaction. The midwives 188 (research assistants) observed and completed the effectiveness of the breastfeeding 189 questionnaire in both normal breastfeeding and during the intervention. 190 Intervention 191 The breastfeeding arm sling innovation has been designed and tailored by 192 using spandex for the sleeves, filled with elastic and attached with 6 cm leather, see 193 Fig. 2. The spandex used for both arm wear is 5.0 cm. apart and has two straps that . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 12 194 are 63 x 7.5 cm. Both ends of the spandex are attached to Velcro straps in two 195 positions to allow adjustment of the size according to the baby's size. 196 Fig 2. This is the Fig 2 Title. Breastfeeding arm sling innovation 197 In the first step of applying the support equipment, the midwives (research 198 assistants) helped the mother to wear the sheath of the breastfeeding arm sling 199 innovation and wrap the equipment around the baby. When the baby was latched on 200 and feeding, the midwives (research assistants) helped the mother to adhere the 201 equipment for a firm hold, so that the mother's arm touched closely the baby's back to 202 support breastfeeding. This technique helped the mother's arm to touch the baby's 203 back, therefore enabling her to hold the newborn baby closer. An advantage of this 204 approach is that it prevents fatigue of the wrists and shoulders of the mothers during 205 breastfeeding. 206 As this research is in the experimental stage, a helper was required to support 207 how to apply the breastfeeding arm sling innovation. This initial help to use the 208 breastfeeding arm sling innovation showed mothers how to apply and use the 209 breastfeeding arm sling by themselves for further breastfeeding (Fig 2). 210 Statistical analysis 211 212 All data analysis was performed using the IBM SPSS Statistics 27.0.1.0 213 software package [18]. Data were expressed as means and standard deviations (SD). 214 A comparison of the means of the two groups within subjects was evaluated for 215 significance using paired t-tests. A p-value of less than 0.05 was considered 216 significant. 217 Ethical considerations 218 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 13 219 The study was approved by the Ethics Committee on Human Subjects of the 220 Faculty of Medicine at Ramathibodi Hospital, Mahidol University, Thailand (IRB COA. 221 MURA2021/949), in line with the Human Research Protection such as Declaration of 222 Helsinki, The Belmont Report, and the International Conference on Harmonization in 223 Good Clinical Practice (ICH-GCP). 224 Results 225 Participants’ demographic characteristics 226 A total of 46 postpartum women participated in the study ranging in age from 227 19 to 40 years with a mean age of 29 years (SD = 5.65). Gestational age ranged from 228 37-41 weeks (mean gestational age 38 weeks, SD = 1.09 weeks). Mothers who 229 participated in the study were post-birth on their first day n = 18 (54.5 %), second day 230 n= 9 (27.3 %), and third day n=6 (18.2%). The babies of the participants had a mean 231 weight of 3151 grams. 232 Differences in the effectiveness of breastfeeding observed 233 by mothers between groups 234 The results of paired t-tests showed that the effectiveness of breastfeeding 235 reported by mothers between using a normal cross-cradle hold position and using a 236 cross-cradle hold position with breastfeeding arm sling innovation was statistically 237 significantly different (t = 4.32, P < 0.001). The difference in total scores of using 238 breastfeeding arm sling innovation and normal breastfeeding was statistically 239 significant (hold the baby securely without slipping: t=5.68, p<0.001; feeling no pain at 240 the nipples while the baby is suckling: t=4.76, p <0.001; baby can continue to suck: 241 (t=2.09, p <0.001); baby held close to mother’s body: t=5.76, p <0.001; No pain felt at . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 14 242 the breast during sitting to breastfeed continuously: t=4.24, p <0.001), as presented 243 in table 1. 244 Table 1. Comparison of the effectiveness of breastfeeding between using 245 normal cross-cradle hold position and using cross-cradle hold position with 246 breastfeeding arm sling innovation by mothers Using breastfeeding arm sling innovation equipment Normal breastfeeding Effectiveness of breastfeeding MEAN SD MEAN SD t p-value 1. Hold the baby tightly without slipping 3.24 0.67 2.20 1.02 5.68 <0.001 2. The feeling of no pain at the nipples while the baby is suckling 2.63 0.74 2.04 0.89 4.76 <0.001 3. Baby can continue to suck 3.02 0.86 2.33 0.97 2.09 <0.001 4. Baby held close to mother’s body 3.28 0.78 2.24 1.08 5.76 <0.001 5. No pain felt at the breast during sitting to breastfeed continuously 2.65 0.77 1.96 0.89 4.24 <0.001 Total 2.97 0.60 2.15 0.80 4.32 <0.001 247 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 15 248 Differences in the effectiveness of breastfeeding observed 249 by midwives between groups 250 Table 2 shows the effectiveness of breastfeeding observed by the midwife 251 and indicates a significant difference in the effects of signs of baby attached during 252 breastfeeding between normal breastfeeding and using breastfeeding arm sling 253 innovation in all outcomes. Compared with normal breastfeeding, using 254 breastfeeding arm sling innovation increased significantly as greater areola seen 255 above the baby’s top lip (t = 6.03, p <0.001); baby’s chin touches breast (t = 6.26, p 256 <0.001); baby’s head and body in line (t = 7.46, p <0.001); baby’s mouth open wide 257 (t = 6.49, p <0.001); baby’s cheeks do not dimple during breastfeed (t = 7.29, p 258 <0.001). 259 Table 2. Comparison of the effectiveness of breastfeeding between using 260 normal cross-cradle hold position and using cross-cradle hold position with 261 breastfeeding arm sling innovation by midwife (researcher assistance) Using breastfeeding arm sling innovation equipment Normal breastfeeding Effectiveness of breastfeeding MEAN SD MEAN SD t p-value 1. More areola seen above baby’s top lip 2.93 0.77 2.22 0.59 6.03 <0.001 2. Baby’s chin touches breast 3.08 0.66 2.34 0.71 6.26 <0.001 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 16 3. Baby’s head and body in line 3.24 0.77 2.04 0.87 7.46 <0.001 4. Baby’s mouth open wide 3.24 0.82 2.37 0.77 6.49 <0.001 5. Baby’s cheeks do not dimple during breastfeeding 3.30 0.76 2.48 0.72 7.29 <0.001 Total 3.16 0.64 2.29 0.59 8.93 <0.001 262 263 Mothers’ satisfaction using breastfeeding arm sling 264 innovation 265 The majority of the mothers were satisfied with the suitability of using the 266 breastfeeding arm sling innovation design (52.9%, size and length 44.1% and fabric 267 used 41.2%). While half (50%) of the mothers were satisfied with the appearance of 268 the breastfeeding arm sling innovation, (41.2%) reported that they were very satisfied 269 with the non-slippage. Meanwhile, satisfied level of the features of easy to use 270 (41.2%), ease of disassembly (41.2%), and ease of cleaning (38.2%) were reported 271 by the mothers (Table 3). 272 Table 3. Mothers’ satisfaction using breastfeeding arm sling innovation Satisfaction levels (%)How satisfied are you with using the breastfeeding arm sling innovation Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied Easy-to-use features 1) Easy to use 17.6 41.2 35.3 2.9 2.9 . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 17 2)Non slippage 41.2 41.2 17.6 3)Easy to disassemble 5.9 41.2 41.2 11.8 4)Easy to clean 38.2 38.2 23.5 Suitability of equipment 5)Design 14.7 52.9 29.4 2.9 6) Size and length 26.5 44.1 26.5 2.9 7) Beauty 11.8 50.0 35.3 2.9 8) Fabric used 32.4 41.2 23.5 2.9 Trial-ability 9)The ability to hold a baby to breastfeed 35.3 41.2 17.6 5.9 10)Ease of carrying a baby 35.3 41.2 17.2 5.9 11)Pain in the arm while holding the baby 35.3 29.4 23.5 11.8 12)Tension in the wrist while holding the baby 20.6 44.1 26.5 8.8 Observability 13)Satisfaction with the use of the innovation for breastfeeding 32.4 38.2 23.5 5.9 14)Feelings of Confidence in Breastfeeding 38.2 35.3 20.6 5.9 273 274 Regarding the trial-ability, (44.1%) of mothers reported the breastfeeding arm sling 275 innovation helped to reduce tension in the wrist while holding the baby. Mothers 276 reported that they were satisfied with their ability to hold their baby to breastfeed . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 18 277 (41.2%) and ease of carrying baby (41.2%). Overall, (32.4%) of mothers felt very 278 satisfied with the use of breastfeeding arm sling innovation and (38.2%) reported 279 feeling confident in breastfeeding. 280 Discussion 281 The development of innovations model is a new concept in the nursing and 282 midwifery process for developing, improving, and adapting products or procedures to 283 significantly benefit outcomes [10]. Results of the present study show the clinical 284 usefulness of the breastfeeding arm sling innovation in supporting breastfeeding. The 285 findings from this current study showed that mothers and midwives reported the 286 effectiveness of breastfeeding between using a normal cross-cradle hold position and 287 using a cross-cradle hold position with breastfeeding arm sling innovation was 288 statistically significantly different in all-term supports (t= 4.32, p <0.001) included 289 holding the baby so that their face touched the mother’s breast, their head and body 290 was in alignment with their mother’s breast, mouth wide open, and more of the areola 291 was visible above the baby's top lip than below the lower lip. These findings are in 292 accordance with Rahim et al. study, who emphasised success of the breastfeeding 293 process depends on the accuracy of the position and attachment of the baby to the 294 mother’s breast and the ability of the baby to suck [19]. 295 For a good attachment and effective breastfeeding, the baby's body positioning and 296 latching technique are crucial [9]. Improper latch and inappropriate infant positioning 297 can cause nipple pain and trauma [20]. Results from this current study demonstrate 298 that the breastfeeding arm sling innovation helped mothers to breastfeed and 299 decreased the feeling of pain at the nipples while the baby was latched on and feeding. 300 This significant improvement in comfort helped to encourage continued breastfeeding. . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 19 301 The use of an innovative breastfeeding arm sling helped the mothers who participated 302 in this study to hold the baby’s body without any slipping during breastfeeding so that 303 the baby’s mouth and head were in a position in alignment with the nipple. Correct 304 positioning and attachment of newborns during breastfeeding was one of the 305 recommendations by Kent et al. [21], to help reduce nipple pain, increase the duration 306 of breastfeeding, and reduce breastfeeding problems. 307 Breastfeeding can be challenging for first-time mothers who have little experience of 308 breastfeeding and newborns who have not yet learned how to properly latch on to the 309 breast [11]. The current study’s results show that the breastfeeding arm sling 310 innovation helped mothers feel less pain in the arm while holding the baby and sitting 311 to breastfeed continuously. The study's findings are consistent with previous research 312 demonstrating that innovations can address patient demands or help solve problems, 313 leading to better outcomes for patients [10]. The first-time mothers in this study valued 314 the breastfeeding arm sling innovation and felt very satisfied as it helped them feel 315 comfortable during breastfeeding. This may be due to the breastfeeding arm sling 316 innovation fitting the mother's arm to promote a correct position and enabling her to 317 touch the newborn baby's back so that she can hold her baby closer during 318 breastfeeding. Given the appropriate posture during breastfeeding, the breastfeeding 319 arm sling innovation is considered acceptable among first-time mothers, with most 320 mothers using it and reporting more confidence in breastfeeding. 321 The breastfeeding arm sling innovation was reported to have very satisfactory features 322 due to its non-slipping benefit. With the features of easy to use and disassemble, 323 however, this breastfeeding arm sling innovation required assistance to help mothers 324 apply the equipment, wrapping it around the baby in order to support the correct 325 position when the baby was breastfeeding. Self-application needs to be factored in . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 20 326 when considering the development of the breastfeeding arm sling innovation in the 327 future to help mothers breastfeed independently. 328 A strength of this study is that mothers were very willing to participate in the 329 study and this is also reflected in the high levels of satisfaction reported. Midwife 330 assessors had preparatory training to assist mothers who agreed to participate. 331 However, the assessors were known to the mothers, and this may have influenced 332 their views and experiences positively or negatively as continuity of care is beneficial 333 but may also have an impact on outcomes. The quasi-experimental study design 334 allowed the participants to be their own control group, but findings are self-reported 335 and must be viewed cautiously. The research study used a non-randomised design, 336 therefore, other confounding factors not controlled for may have influenced the 337 findings and therefore this limits the inference of the research results. Another 338 limitation concerning this study was that it was limited to only first-time mothers, which 339 makes it difficult to generalise the findings to other groups of childbearing women. 340 Since the breastfeeding arm sling innovation in the present study applies to term 341 newborn babies, future development would need to consider investigation as to 342 whether preterm and differences in the baby weights would achieve similar results as 343 reported in the present study. 344 Conclusions 345 The development of innovations model in nursing is a new concept in the 346 nursing process for developing, improving, or adapting products or procedures to 347 significantly benefit outcomes and respond directly to patient needs. The 348 breastfeeding arm sling breastfeeding innovation contributes to the effectiveness of 349 breastfeeding by assisting and supporting the mother and baby’s position to . CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint 21 350 breastfeed more comfortably. In conclusion, this study provides emerging evidence 351 that the breastfeeding arm sling assisted first-time mothers to feel comfortable, 352 confident, and helped them to continue breastfeeding. However, further research is 353 required to confirm or refute these initial findings. 354 Acknowledgments 355 The authors would like to gratefully thank the Faculty of Medicine, Ramathibodi 356 Hospital, Mahidol University for their support grant and all the participants who took 357 part in the present study. 358 Funding Sources: Ramathibodi School of Nursing Funds, Faculty of 359 Medicine, Ramathibodi Hospital, Mahidol University, Thailand 360 References 361 1. World Health Organization [Internet]. Breastfeeding. [cited 2021 August 23]. 362 Available from: https://www.who.int/health topics/breastfeeding. 363 2. World Health Organization [Internet]. Infant and young child feeding: Model 364 Chapter for Textbooks. c2009 - [cited 2021 August 23]. Available: http: // 365 www.who.int/inf.htm. 366 3. National Statistical Office Thailand [Internet]. Summary of Key Indicators June 367 2020. c2019- [cited 2021 August 23]. Available from: 368 https://www.unicef.org/thailand/. 369 4. 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CC-BY 4.0 International licenseIt is made available under a perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in(which was not certified by peer review)preprint The copyright holder for thisthis version posted January 25, 2023. ; https://doi.org/10.1101/2023.01.24.23284943doi: medRxiv preprint