NCT06262243

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 20, 2024

Last Update Submit

February 8, 2024

Conditions

Keywords

Caesarean sectionelectric blanketnursing

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Bristol Breastfeeding Assessment Tool

    two days

  • Insufficient Milk Perception Scale

    two days

Study Arms (2)

experimental group

EXPERIMENTAL

The group that will receive routine care and electric blankets after cesarean section.

Other: electric blankets

control group

NO INTERVENTION

The group that will receive routine care after cesarean section.

Interventions

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.

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research Hospital

Samsun, İ̇lkadim, 55080, Turkey (Türkiye)

RECRUITING

Study Officials

  • Ebru ŞAHİN

    Ordu Univercity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this randomized controlled study, 78 mothers, 39 in each group, will be included in the intervention and control groups that meet the criteria for participation in the study. The researcher will give general information about the research to the mothers in the intervention and control groups during hospitalization and nurse admission, and their written informed consent will be obtained.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The research is a randomized controlled experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2024

First Posted

February 15, 2024

Study Start

January 15, 2024

Primary Completion

August 30, 2024

Study Completion

September 1, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations