ClinicalTrials.gg
RecruitingNCT06262243Updated Feb 15, 2024

The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum

An interventional study of electric blankets in Cesarean Section, sponsored by T.C. ORDU ÜNİVERSİTESİ. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cesarean Section

Keywords

  • Caesarean section
  • electric blanket
  • nursing
03

In context

Lead sponsor

T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    experimental group

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

    Other: electric blankets

  • No intervention
    control group

    The group that will receive routine care after cesarean section.

Interventions

  • Otherelectric 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: two days

  2. 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.

    Time frame: ten days

Secondary outcomes

  1. 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".

    Time frame: two days

  2. 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.

    Time frame: two days

07

Study locations

1 of 1 sites recruiting
  • Samsun Training and Research Hospital
    Samsun, İ̇lkadim 55080, Turkey
    Recruiting
    • TUBA ÇITAK · Contacttubadlkc@gmail.com · 05349265496
    • Ebru ŞAHİN · Sub investigator
    • Tuba ÇITAK · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06262243
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
tuba çıtak (Principal Investigator, T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Feb 15, 2024
Start date
Jan 15, 2024
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Feb 15, 2024

Study contacts

TUBA ÇITAK
Contact
tubadlkc@gmail.com
05349265496
EBRU ŞAHİN
Contact
ebrugabalci_@hotmail.com
05062569764
Ebru ŞAHİN
principal investigator · Ordu Univercity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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