Warm Pads Applied to the Breast During Episiotomy Repair

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: Warm Pads Applied to the Breast

• Registration Number: NCT06119646
• Lead Sponsor: Selcuk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-25
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm Pads Applied to the Breast	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Selcuk University Faculty of Medicine Hospital; 🇹🇷 Konya, Selçuklu, Turkey