Warm Pads Applied to the Breast During Episiotomy Repair

NCT ID: NCT06119646

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-08-30

Brief Summary

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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

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Warm Pads Applied to the Breast

Intervention Type OTHER

Applying a warm pad to a breast during episiotomy repair

Control

A routine care was performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Warm Pads Applied to the Breast

Applying a warm pad to a breast during episiotomy repair

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lansinoh Laboratories

INDUSTRY

Sponsor Role collaborator

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Asiye Tutca

Midwifery, Student of Master

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University Faculty of Medicine Hospital

Konya, Selçuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 34305016 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 11572532 (View on PubMed)

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.

Reference Type RESULT
PMID: 10620381 (View on PubMed)

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.

Reference Type RESULT
PMID: 32516210 (View on PubMed)

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.

Reference Type RESULT
PMID: 24391731 (View on PubMed)

Other Identifiers

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223278001012

Identifier Type: -

Identifier Source: org_study_id

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