EVALUATION OF THE EFFECT OF ACTIVE WARMING APPLIED TO THE MOTHER DURING CESAREAN SECTION ON POST-BREASTFEEDING OUTCOMES: A RANDOMIZED CONTROLLED STUDY
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Kutahya Health Sciences University
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Breastfeeding Success
概览
简要总结
Hypothermia is a complication of cesarean section and a cause of breastfeeding problems. Preventing maternal hypothermia is one of the goals of the enhanced postoperative recovery (ERAS) protocol and is important for the health of both mother and baby. This clinical trial aims to determine the effects of active warming during and after cesarean delivery on breastfeeding outcomes, thermal comfort, and perceived insufficient milk supply.
The primary questions it aims to answer are:
- To evaluate the effect of active warming during cesarean delivery on mothers' perception of thermal comfort.
- To evaluate the effect of active warming after cesarean delivery on mothers' perceived insufficient milk supply.
- To determine the effect of active warming after cesarean delivery on breastfeeding success.
Participants:
Warming will be provided using an active warming bed during cesarean delivery (45 minutes). Warming will continue in the postpartum care unit (45 minutes).
The control group will not receive any warming and will receive the hospital's standard care procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Primiparous, singleton pregnancy
- •Gestational age \>37 weeks, elective cesarean section under spinal anesthesia
- •No issues with breastfeeding the baby or herself during the postpartum period
- •Voluntarily participating
排除标准
- •Those with a gestational age of less than 37 weeks,
- •Those with an urgent delivery decision or those with accompanying comorbidities (severe preeclampsia, placenta previa, placental abruption, umbilical cord prolapse, fetal distress),
- •those with multiple pregnancies,
- •those with a core body temperature above 37.5 °C,
- •those who started cesarean delivery with spinal anesthesia and later switched to general anesthesia due to complications,
- •those with known impaired thermoregulation or thyroid disorder
- •Translated with DeepL.com (free version)
研究组 & 干预措施
Intervention
Active warming group
干预措施: active warming (Other)
Intervention
Active warming group
干预措施: active warming II (Other)
Control
Control group
结局指标
主要结局
Breastfeeding Success
时间窗: Postperative Day 1- First breastfeeding session
Evaluation will be performed using the LATCH breastfeeding diagnostic tool. The LATCH Breastfeeding Assessment Scale consists of 5 sub-dimensions: Latch, Audible swallowing, Type of nipple, Comfort, and Hold. Each item is scored between 0 and 2 points. The total score ranges from 0 to 10. Higher scores indicate more effective and successful breastfeeding.
Breastfeeding success
时间窗: Postoperative Day 1, 24.hour
Evaluation will be performed using the LATCH breastfeeding diagnostic tool. The LATCH Breastfeeding Assessment Scale consists of 5 sub-dimensions: Latch, Audible swallowing, Type of nipple, Comfort, and Hold. Each item is scored between 0 and 2 points. The total score ranges from 0 to 10. Higher scores indicate more effective and successful breastfeeding.
Perception of insufficient milk
时间窗: Postoperative Day 1, 24. hour
The assessment will be performed using the Insufficient Milk Perception Scale. The Perception of Insufficient Milk (PIM) Scale is used to assess mothers' subjective perceptions of whether their milk supply is sufficient to feed their infants. The scale consists of items that question the mother's perception of milk quantity, infant satisfaction, and the adequacy of breastfeeding. Items are generally scored using a Likert scale, and the total score ranges between predetermined minimum and maximum values. Higher scores indicate a higher level of perceived insufficiency in the mother's milk supply. A score of "0" indicates that milk is perceived as completely insufficient, while a score of "10" indicates that milk is perceived as completely sufficient. The scale is scored from 0 to 50. A higher score indicates a higher perception of milk sufficiency.
Thermal comfort
时间窗: Preoperative Day 1, Before the cesarean section
The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.
Thermal comfort II
时间窗: Day 1, During the cesarean section (at 15 minutes)
The Temperature Comfort Perception Scale will be used. The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.
Thermal comfort III
时间窗: Postoperative Day 1,After the cesarean section (at 30 minutes)
The Thermal Comfort Perception Scale will be used. The Thermal Comfort Scale is a subjective scale used to assess how comfortable, acceptable, or uncomfortable individuals perceive the temperature conditions of their environment. The scale is generally a single-item or multi-item structure that questions the perception of hot-cold and the level of thermal comfort. Scores range between predetermined minimum and maximum values, with higher scores indicating a higher level of thermal comfort and lower scores indicating thermal discomfort. The scale is a 5-point Likert type with options of 1 "none", 2 "somewhat", 3 "moderately", 4 "a lot", and 5 "very much". The lowest possible score on the 11-item scale is 11, and the highest is 49.
Perception of insufficient milk
时间窗: Postoperative Day 1, First breastfeeding session
Assessment will be made using the Insufficient Milk Perception Scale. The Perception of Insufficient Milk (PIM) Scale is used to assess mothers' subjective perceptions of whether their milk supply is sufficient to feed their infants. The scale consists of items that question the mother's perception of milk quantity, infant satisfaction, and the adequacy of breastfeeding. Items are generally scored using a Likert scale, and the total score ranges between predetermined minimum and maximum values. Higher scores indicate a higher level of perceived insufficiency in the mother's milk supply. A score of "0" indicates that milk is perceived as completely insufficient, while a score of "10" indicates that milk is perceived as completely sufficient. The scale is scored from 0 to 50. A higher score indicates a higher perception of milk sufficiency.
次要结局
未报告次要终点
研究者
Havva Yeşildere Sağlam
Assistant Professor
Kutahya Health Sciences University