- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262243
The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum
The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum Comfort, Pain, Milk Quantity and Breastfeeding Success
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: TUBA ÇITAK
- Phone Number: 05349265496
- Email: tubadlkc@gmail.com
Study Contact Backup
- Name: EBRU ŞAHİN
- Phone Number: 05062569764
- Email: ebrugabalci_@hotmail.com
Study Locations
-
-
İ̇lkadim
-
Samsun, İ̇lkadim, Turkey, 55080
- Recruiting
- Samsun Training and Research Hospital
-
Contact:
- TUBA ÇITAK
- Phone Number: 05349265496
- Email: tubadlkc@gmail.com
-
Sub-Investigator:
- Ebru ŞAHİN
-
Principal Investigator:
- Tuba ÇITAK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
The group that will receive routine care and electric blankets after cesarean section.
|
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. |
|
No Intervention: control group
The group that will receive routine care after cesarean section.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum comfort scale
Time Frame: two days
|
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
|
|
A Tool to Evaluate the Amount of Breast Milk the Baby Receives
Time Frame: ten days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bristol Breastfeeding Assessment Tool
Time Frame: two days
|
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
|
|
Insufficient Milk Perception Scale
Time Frame: two days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ebru ŞAHİN, Ordu Univercity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ORDUU-HEM-TÇ-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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