Clinical trial NCT06119646: Warm Pads Applied to the Breast During Episiotomy Repair
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: warm pads
perception of insufficient milk
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Lansinoh Laboratories
First posted: 2023-11-07
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Introductory Information Form
timeFrame: pre-intervention
measure: Postpartum Milk Expression and Amount Information Form
timeFrame: in the first hour in postpartum period
Secondary outcomes:
measure: Primiparous Breastfeeding Motivation Scale (PBMS)
timeFrame: in the second hour in postpartum period
measure: Perception of Insufficient Milk Supply Questionaire
timeFrame: in the second hour in postpartum period
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Faculty of Medicine Hospital
state: Selçuklu
Study officials:
References:
citation: 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.
citation: 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.
citation: Lin, L. ve Zhang, T. (2011). Playing exergames in the classroom: Pre-service teachers' motivation, passion, effort, and perspectives. JTATE, 19(3), 243-260.
citation: 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.
citation: 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.
citation: 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.
citation: 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.