BreastfeedingNCT06119646
Warm Pads Applied to the Breast During Episiotomy Repair
A study testing Warm Pads Applied to the Breast in people with Breastfeeding, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Warm Pads Applied to the Breast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Show all 9Show fewer
- There is no open wound on the breast,
- A singleton pregnancy,
- Women who are open to communication and mentally and emotionally healthy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Medicine Hospital
Konya, Selçuklu, 42130
About this study
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
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
- Being tested
- Warm Pads Applied to the Breast
- Keywords
- warm pads, perception of insufficient milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Pads Applied to the BreastOther
Applying a warm pad to a breast during episiotomy repair
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Warm Pads Applied to the Breast |
| Control | No intervention | A routine care was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: in the first hour in postpartum period
Secondary outcomes (2)
Primiparous Breastfeeding Motivation Scale (PBMS)
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.
Measured: in the second hour in postpartum period
Perception of Insufficient Milk Supply Questionaire
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.
Measured: in the second hour in postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Lansinoh Laboratories
- Responsible party
- Principal investigator, Asiye Tutca, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119646
- Sponsor's protocol ID
- 223278001012
- Status last verified
- Feb 2025
- First submitted
- 27 Oct 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared with other researchers.
Publications
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.
PubMed 34305016Gökçeoğlu, 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.
Lin, L. ve Zhang, T. (2011). Playing exergames in the classroom: Pre-service teachers' motivation, passion, effort, and perspectives. JTATE, 19(3), 243-260.
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.
PubMed 11572532Ryan 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.
PubMed 10620381Saus-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.
PubMed 32516210Stockdale 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.
PubMed 24391731
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06119646
- Acronym / sponsor ID
- 223278001012
- Conditions
- Breastfeeding
- Keywords
- warm pads, perception of insufficient milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Lansinoh Laboratories
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm Pads Applied to the Breast | Experimental | Other: Warm Pads Applied to the BreastWhen 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. |
| Control | No intervention | –A routine care was performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm Pads Applied to the BreastApplying a warm pad to a breast during episiotomy repair | Other | Warm Pads Applied to the Breast |
Primary outcome
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.
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.
2 secondary outcomes
Primiparous Breastfeeding Motivation Scale (PBMS)
Time frame: in the second hour in postpartum period
Perception of Insufficient Milk Supply Questionaire
Time frame: in the second hour in postpartum period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Results publication: PubMed 34305016An 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.
- Results publicationGökçeoğlu, 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.
- Results publicationLin, L. ve Zhang, T. (2011). Playing exergames in the classroom: Pre-service teachers' motivation, passion, effort, and perspectives. JTATE, 19(3), 243-260.
- Results publication: PubMed 11572532McCarter-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.
- Results publication: PubMed 10620381Ryan 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.
- Results publication: PubMed 32516210Saus-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.
- Results publication: PubMed 24391731Stockdale 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.
- Individual participant dataSharing planned: Yes. The IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Pads Applied to the Breast in people with Breastfeeding, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: pre-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119646, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.