Warm Pads Applied to the Breast During Episiotomy Repair

Sponsor
Selcuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119646
Collaborator
Lansinoh Laboratories (Industry)
210
1
2
13.2
15.9

Study Details

Study Description

Brief Summary

H1-1 Hypothesis: Warm pads applied to the breast during episiotomy repair in the intervention group will have an effect on increasing milk production compared with the control group.

H1-2 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on increasing breastfeeding motivation compared to the control group.

H1-3 Hypothesis: Warm pads applied to the breast of the intervention group during episiotomy repair will have an effect on reducing the mother's perception of insufficient milk compared to the control group.

Condition or Disease Intervention/Treatment Phase
  • Other: Warm Pads Applied to the Breast
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Warm Pads Applied to the Breast During Episiotomy Repair on the Amount of Milk, Breastfeeding Motivation and the Perception of Insufficient Milk
Actual Study Start Date :
Jul 25, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Warm Pads Applied to the Breast

When repairing the episiotomy of a pregnant woman who has given birth, a pad heated in a microwave oven at 180 W for 1 minute is applied to each breast for 20 minutes. The application is made when the temperature of the pad, measured with a thermometer, reaches a maximum of 40.5 C.

Other: Warm Pads Applied to the Breast
Applying a warm pad to a breast during episiotomy repair

No Intervention: Control

A routine care was performed.

Outcome Measures

Primary Outcome Measures

  1. Introductory Information Form [pre-intervention]

    The Introductory Information Form is a 15-item survey form prepared by researchers based on the literature. The Introductory Information Form includes 10 questions on socio-demographic characteristics of pregnant women and their partners and 5 questions on obstetric characteristics of pregnant women.

  2. Postpartum Milk Expression and Amount Information Form [in the first hour in postpartum period]

    Postpartum Milk Expression and Amount Information Form aims to be evaluated by researchers by asking 8 questions to the intervention group and 6 questions to the control group. The questions were prepared by the researcher. There are statements that need to be measured quantitatively and recorded by the researcher.

Secondary Outcome Measures

  1. Primiparous Breastfeeding Motivation Scale (PBMS) [in the second hour in postpartum period]

    The scale, whose Turkish validity and reliability was confirmed by Akçay and Demirgöz Bal in 2019, was published by Stockdale et al. in 2013. PBMS is a 37-item scale developed to evaluate the postnatal breastfeeding motivation in primipara. The scale has four sub-dimensions of "The value placed on breastfeeding", "Self-efficacy", "Perceived support from the midwife" and "Expectation of success". High scores from the scale indicate high breastfeeding motivation, low scores indicate low breastfeeding motivation.

  2. Perception of Insufficient Milk Supply Questionaire [in the second hour in postpartum period]

    The scale, developed by McCarter-Spaulding and Kearney in 2001, consists of 6 questions to determine the perception of insufficient breast milk. The Turkish validity and reliability of the scale was conducted by Gökçeoğlu and Küçükoğlu in 2014. The first question of the scale asks whether the mother feels that her milk is sufficient, and is answered with 'yes' or 'no'. Other questions on the scale aim to measure the perception of milk inadequacy. These questions are scored on a scale from 0 to 10 ('0' means the milk is perceived as completely inadequate, '10' means the milk is perceived as completely sufficient). The scale can produce scores from 0 to 50, and a higher total score indicates an increasing perception of milk adequacy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • First pregnancy,

  • Those who are 18 years or older,

  • Can speak Turkish and express themselves in Turkish,

  • Do not have any disability (such as sight, hearing),

  • Gave birth after >37 weeks of pregnancy,

  • Who have had a normal birth and have had an episiotomy,

  • There is no open wound on the breast,

  • A singleton pregnancy,

  • Women who are open to communication and mentally and emotionally healthy.

Exclusion Criteria:
  • Those who do not agree to work

  • Those who want to leave for any reason during the application process

  • Having postpartum haemorrhage,

  • Women who develop any postpartum complications,

  • Women whose babies are admitted to the neonatal intensive care unit.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selcuk University Faculty of Medicine Hospital Konya Selçuklu Turkey 42130

Sponsors and Collaborators

  • Selcuk University
  • Lansinoh Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asiye Tutca, Midwifery, Student of Master, Selcuk University
ClinicalTrials.gov Identifier:
NCT06119646
Other Study ID Numbers:
  • 223278001012
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Asiye Tutca, Midwifery, Student of Master, Selcuk University

Study Results

No Results Posted as of Nov 7, 2023