Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06262243
Other study ID # ORDUU-HEM-TÇ-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date September 1, 2024

Study information

Verified date February 2024
Source T.C. ORDU ÜNIVERSITESI
Contact TUBA ÇITAK
Phone 05349265496
Email tubadlkc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.


Description:

After cesarean section, mothers face more problems than mothers who give birth normally. Post-cesarean pain, breastfeeding problems, anesthesia-related side effects, and postpartum complications are important reasons affecting maternal comfort. After a cesarean section, mothers may experience hypothermia due to the low temperature in the operating room, the incision, and the effects of spinal/general anesthesia. In mothers who develop hypothermia after cesarean section, undesirable results may occur in physiological parameters such as fever, pulse, blood pressure, pain, and intestinal motility. Therefore, body temperature, blood pressure, pulse, saturation, pain, time to first flatus and defecation are the main factors that determine patient comfort after surgery. In the postoperative period, both pharmacological and non-pharmacological treatment methods are used to reduce pain, increase the amount of milk, and increase intestinal motility. It is stated in the literature that non-pharmacological methods such as early mobilization, chewing gum, early oral hydration (consumption of water, warm water, tea, coffee), and hot application are effective in increasing intestinal motility. Using active and passive heating methods to prevent hypothermia after cesarean section are practices that affect postpartum comfort. With this study, it is expected that heating with an electric blanket will prevent hypothermia, increase postpartum comfort, reduce pain, and increase breastfeeding success by affecting the amount of milk.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date September 1, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and over, - At least primary school graduate - The one who is married - Primiparous women who gave birth at term, - Having the baby with her after birth - Those who agreed to participate in the study Exclusion Criteria: - Those who gave birth at less than 37 weeks of gestation - Mothers with babies weighing less than 2500 grams - The newborn has a congenital anomaly, - Those with a history of high-risk pregnancy - Those who received any food, including water, other than breast milk until the 10th day of follow-up - Those with cardiovascular disease problems, those with a history of neurological diseases - Mothers with nipple problems - Diabetes Mellitus, those diagnosed with gestational diabetes mellitus, - Mothers who gave birth with general anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electric blankets
While the patient is in surgery; An electric blanket will be placed under the bed mattress, and the bed will be placed on the electric blanket. The bed sheet will be laid, and the blanket used in the clinic will be laid on top of the bed sheet. -The electric blanket will be turned on at "hot" setting 20 minutes before the patient leaves the surgery. After the mother is placed in a heated bed, the electric blanket will be unplugged when the temperature reaches 36.5.

Locations

Country Name City State
Turkey Samsun Training and Research Hospital Samsun I?lkadim

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum comfort scale Postpartum comfort scale, consists of 34 items. A 5-point Likert type scale scoring system was used. For each item, expressions and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made. Accordingly, the lowest score to be obtained from the scale is 34 and the highest score is 170. two days
Primary A Tool to Evaluate the Amount of Breast Milk the Baby Receives It consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction, and the features of each section are collected in 3 groups and evaluated out of 0, 1, 2 points. A full score of 10 was considered as the score where breast milk was obtained in the best possible way, and 7 and below were considered as the scores where the breast milk was obtained insufficiently. ten days
Secondary Bristol Breastfeeding Assessment Tool The scale was developed to evaluate common breastfeeding problems and adequacy in the postpartum period. The mother is observed by the midwife/nurse during breastfeeding, and the mother and baby are evaluated in line with the criteria and a form is filled out. The measurement tool is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". two days
Secondary Insufficient Milk Perception Scale The first question asks whether the mother perceives her milk to be sufficient. The mother answers this question with "yes" or "no". Other questions of the scale aim to measure the perception of inadequacy of milk. The mother is asked to score these questions between 0-10. "0" indicates that the milk is perceived as completely inadequate, and "10" indicates that the milk is perceived as completely sufficient. A minimum of 0 and a maximum of 50 points can be obtained from the scale. two days
See also
  Status Clinical Trial Phase
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03631329 - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Active, not recruiting NCT03760718 - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery Early Phase 1
Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
Terminated NCT01687972 - INSORB Versus Subcuticular Sutures at Cesarean Section Phase 1
Withdrawn NCT01211431 - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine Phase 4
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Completed NCT00987701 - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors N/A
Completed NCT01049477 - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery N/A
Terminated NCT00524511 - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Completed NCT00375986 - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section N/A
Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Recruiting NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A