Warm Pads Applied to the Breast During Episiotomy Repair

NCT06119646 | Completed

• 1 other identifier: 223278001012
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

warm pads; perception of insufficient milk

Outcome Measures

Primary Outcomes (2)

• Introductory Information Form

  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.

  pre-intervention

• Postpartum Milk Expression and Amount Information Form

  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.

  in the first hour in postpartum period

Secondary Outcomes (2)

• Primiparous Breastfeeding Motivation Scale (PBMS)

  in the second hour in postpartum period

• Perception of Insufficient Milk Supply Questionaire

  in the second hour in postpartum period

Study Arms (2)

Warm Pads Applied to the Breast

EXPERIMENTAL

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

Control

NO INTERVENTION

A routine care was performed.

Interventions

Warm Pads Applied to the Breast OTHER

Applying a warm pad to a breast during episiotomy repair

Warm Pads Applied to the Breast

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead
• Lansinoh Laboratories: collaborator

Study Sites (1)

Selcuk University Faculty of Medicine Hospital

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

Related Publications (7)

• An official position statement of the Association of Women's Health, Obstetric and Neonatal Nurses. Breastfeeding and the Use of Human Milk. Nurs Womens Health. 2021 Oct;25(5):e4-e8. doi: 10.1016/j.nwh.2021.06.005. Epub 2021 Jul 22. No abstract available.

  PMID: 34305016 RESULT

• Gökçeoğlu, E. ve Küçükoğlu, S. (2018). Validity and Reliability Study of Perception of Insufficient Milk Supply Questionnaire for Turkish Society. International Journal of Innovative Research and Reviews, 2(2), 15-20.

  RESULT

• Lin, L. ve Zhang, T. (2011). Playing exergames in the classroom: Pre-service teachers' motivation, passion, effort, and perspectives. JTATE, 19(3), 243-260.

  RESULT

• McCarter-Spaulding DE, Kearney MH. Parenting self-efficacy and perception of insufficient breast milk. J Obstet Gynecol Neonatal Nurs. 2001 Sep-Oct;30(5):515-22. doi: 10.1111/j.1552-6909.2001.tb01571.x.

  PMID: 11572532 RESULT

• Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.

  PMID: 10620381 RESULT

• Saus-Ortega C. Promoting correct positioning and attachment in breastfeeding infants born by section cesarean in the La Fe Hospital in Spain: a best-practice implementation project. JBI Evid Implement. 2020 Sep;18(3):297-307. doi: 10.1097/XEB.0000000000000230.

  PMID: 32516210 RESULT

• Stockdale J, Sinclair M, Kernohan G, McCrum-Gardner E, Keller J. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers. PLoS One. 2013 Dec 31;8(12):e82976. doi: 10.1371/journal.pone.0082976. eCollection 2013.

  PMID: 24391731 RESULT

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwifery, Student of Master

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 7, 2023
• Study Start: July 25, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting in June 2024
• Access Criteria: IPD data will be shared with the principal investigator.

Locations

TU (1)