Breastfeeding, Cesarean Resection, Thermal Comfort
Conditions
Keywords
Cesarean, active warming, thermal comfort, breastfeeding
Brief summary
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: 1. To evaluate the effect of active warming during cesarean delivery on mothers' perception of thermal comfort. 2. To evaluate the effect of active warming after cesarean delivery on mothers' perceived insufficient milk supply. 3. 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.
Interventions
OTHERactive warming
During the cesarean section, heating will be applied at 37 degrees. (45 minutes) Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.
OTHERactive warming II
After the cesarean section, heating will be applied to the recovery area at 37 degrees. (45 minutes) Carbon fiber resistive heating pads are reusable, where a low-voltage electric current flows, causing heat to accumulate in the carbon fibers that make up the blanket's filling. A heating pad will be used to warm participants. This pad has a control unit, is 120 cm long, and is suitable for operating room conditions. It is safe and operates at low voltage. It heats to a maximum of 40 degrees Celsius. In this study, heating will be used to a temperature of 37 degrees Celsius.
Sponsors
Kutahya Health Sciences University
Bilecik Seyh Edebali Universitesi
Kutahya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This is a randomized, controlled, parallel-group interventional study evaluating the effect of active warming applied to mothers during and after cesarean delivery on early postpartum breastfeeding outcomes. Participants will be randomly assigned, via computer-generated allocation, to either the intervention group receiving active warming or the control group receiving standard care without warming. The study will be conducted in a \[single-blind / open-label\] manner. The primary objective is to assess the effect of active warming on breastfeeding success, thermal comfort, and perceived insufficient milk supply.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Success | 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 | 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 | 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. |
| Thermal comfort | 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 | 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 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed