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Completed

NCT Number: NCT06119646

Warm Pads Applied to the Breast During Episiotomy Repair

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Faculty of Medicine Hospital

Konya, Selçuklu, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warm Pads Applied to the Breast

Other

Applying a warm pad to a breast during episiotomy repair

Primary outcomes

  1. Introductory Information Form

    Time frame: 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

    Time frame: 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 outcomes

  1. Primiparous Breastfeeding Motivation Scale (PBMS)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Collaborators

  • Lansinoh Laboratories

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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