The Effect of a Device Developed for Flat or Inverted Nipples on Nipple Length, Breastfeeding and Feeding: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- The mean nipple lengths of the mothers
研究概览
简要总结
Breast milk alone can meet all the elements necessary of babies during the first 6 months. However, some problems prevent breast milk from being taken, including concern about milk insufficiency, hyperlactation, clogged milk ducts, engorgement, mastitis, painful, injured/cracked nipples, flat or inverted nipples.
As there is insufficient nipple projection in mothers with flat or inverted nipples, it has been reported that babies have difficulty latching on to the breast and have problems breastfeeding. Also, it has been found that mothers with nipples shorter than 7 mm need more support. Many interventions are recommended to solve flat or inverted nipple problems.
In our study, a device developed for flat or inverted nipples was used by researchers. Thisa device developed for flat or inverted nipples was developed by researchers based on their experience and literature. This study was designed to evaluate the effects of the device developed for flat or inverted nipples for mother just already giving birth on nipple length, baby's attachment to the breast and breastfeeding duration, "LATCH Breastfeeding Assessment Tool" scores and and the duration of exclusive breastfeeding time in the first 6 months. The hypotheses of the study are as follows: (H1): Nipple length of mothers in the intervention gorup is longer. (H2): Babies in the intervention gorup would have a shorter attachment time on the breast. (H3): Babies in the intervention group have a longer duration of one breastfeeding. (H4): The LATCH breastfeeding diagnosis and evaluation score of the intervention group is higher. (H5): Babies in the intervention gorup have a longer exclusive breastfeeding time.
详细描述
This study employed a randomized controlled experimental design to evaluate the effectiveness of a device developed for flat or inverted nipples developed for mothers with flat or inverted nipples.
The study compared the effect of the flat or inverted nipple device with the injector method on nipple length, breastfeeding duration, exclusive breastfeeding duration and the LATCH Breastfeeding Diagnosis and Assessment Scale.
The research was conducted in an XXXXX University Hospital, Obstetrics and Gynecology Clinic. The population of the study consisted of 700 primiparous mothers who gave birth between November 2020 and November 2021. The inclusion criteria were that the mothers were aged 18 years or older, had normal or cesarean delivery at term, had a history of uncomplicated pregnancy or birth, and had a nipple length of 7 millimeter or less. Mothers with preterm and multiple births, babies with congenital anomalies, and women and babies with any health problems were excluded from the study.
The G*Power program was used to determine the required sample size. The power analysis used the results of a study in which a breastfeeding support program was implemented, evaluated with LACTH scores (experiment: 8.91±.98 and control: 7.78±1.3) and had an effect size of .98. In this study, it was aimed to create a change at the same effect level (.98 large effect) and it was calculated that there should be 29 mothers and babies per group (58 total) in the sample calculation made with 5% alpha margin of error (two-way) and and 90%. However, considering the possibility of loss during data collection, it was decided to include a total of 72 (36 per group) mothers and babies when it was calculated with 20% more for each group. During the follow-up, four mothers from both the interventio and injector groups were excluded for not participating in interviews, and one baby from the intervention group died. Thus, 31 the intervention gorup and 32 the injector group mothers and babies completed the study. Participants were randomly selected using the URN method, considered equivalent to full randomization. When a mother met the selection criteria, a random nurse assigned her to a group.
Research measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Applications were made by the researcher (The intervention group:The device developed for mothers with flat or inverted nipples and the control group:injector method).
Measurements (the diameter and length of the women's nipples, Baby's one time breastfeeding duration, Baby's one time attachment to the breast duration, LATCH scores, Babies exclusive breastfeeding duration in six months) were made by the nurse.
The data were analysed by an independent statistician other than the researchers.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The mothers:
- •were aged 18 years or older,
- •had normal or cesarean delivery at term,
- •had a history of uncomplicated pregnancy or birth,
- •had a nipple length of 7 mm or less.
排除标准
- •The mothers:
- •Mothers with preterm and multiple births,
- •babies with congenital anomalies,
- •women and babies with any health problems were excluded from the study.
结局指标
主要结局
The mean nipple lengths of the mothers
时间窗: Through study completion, an average of 1 year
Immediately after the interventions on the mother's nipples, the nipple length was measured by the nurse.
The duration of baby's one time breastfeeding
时间窗: Through study completion, an average of 1 year
Immediately after the interventions on the The duration of baby's one time breastfeeding was measured by the nurse.
The LATCH score
时间窗: Through study completion, an average of 1 year
Immediately after the interventions on the mother's nipples, the LATCH score was measured by the nurse. LATCH Breastfeeding Diagnosis and Assessment Scale form : The LATCH scale is a diagnostic tool developed based on the Apgar score assessment model. Each criterion of the LATCH Breastfeeding Diagnosis and Assessment Scale is scored 0, 1, 2. Breastfeeding success is assessed by adding up the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success.
Feeding Taypes of Babies
时间窗: Through study completion, an average of 1 year.
Mothers and babies in both groups were contacted by the same nurse after discharge and asked whether the babies had been exclusively breastfed.
The duration of baby's attachment to the breast
时间窗: Through study completion, an average of 1 year
Immediately after the interventions on the mother's nipples, the duration of baby's attachment to the breast was measured by the nurse.
次要结局
未报告次要终点
研究者
Zeynem YILDIRIM BALKAN
Assistant Professor and Principal Investigator
Namik Kemal University