- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07726225
The Effects of Sustainable Lactation Support and Partner Endorphin Massage
The Effects of Sustainable Lactation Support and Partner Endorphin Massage on Mood, Lactation Self-Efficacy, and Maternal Bonding in Primiparous Women During the Postpartum Period
Research Design This study is designed as a randomized controlled experimental study in which participants are blinded.
Location and Characteristics of the Study This research will be conducted in the Obstetrics and Gynecology Department of the State Hospital. State Hospital has been a baby-friendly hospital since 1995. Baby-friendly hospitals are hospitals that encourage breastfeeding, provide mothers with information and correct habits about breastfeeding, and continuously support mothers in initiating and maintaining breastfeeding.In baby-friendly hospitals, breastfeeding consultants trained with up-to-date information provide support to mothers during working hours (08:00-16:00), during pregnancy and the postpartum period, until they are discharged or whenever they visit the outpatient clinic, on topics such as breastfeeding, breast milk, and breastfeeding positions. Midwives and nurses working in the obstetrics and gynecology department provide breastfeeding counseling to mothers during on-call duties and weekends, as well as supporting mothers during working hours.
Related/Independent Variable of the Study In this research; Independent variables: socio-demographic characteristics, partner endorphin massage, midwife breastfeeding support Dependent variables: mood, breastfeeding self-efficacy, and maternal bonding Study Population and Sample The study population consists of women who had normal vaginal deliveries at a state hospital between the specified dates.The sample size was determined as 52 women, based on the mean self-efficacy score calculated using breastfeeding self-efficacy data from the study by Yenal et al., with an effect size of 0.8 at a 95% confidence interval and a representativeness of 0.80. 26 women will be included in the control group and 26 in the experimental group.However, considering data loss, the number was calculated as 30 for the control group and 30 for the experimental group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the research process:
Assignment to Groups and Randomization Randomization will be achieved using the sealed envelope technique.
Control Group; Women participating in the research as the control group will be asked to complete the Informed Consent Form, Personal Data Collection Form, Breastfeeding Self-Efficacy Scale, and Hospital Depression and Anxiety Scale. No intervention will be performed on the women in the control group. They will be called back to the hospital on the 10th day after discharge for postpartum follow-up and a face-to-face interview. During the interview, participants who come to the hospital will be asked to complete the Breastfeeding Self-Efficacy Scale, Hospital Depression and Anxiety Scale, and Mother-Infant Bonding Scale. One month later, participants will be contacted again by phone; the Breastfeeding Self-Efficacy Scale, Hospital Depression and Anxiety Scale, and Mother-Infant Bonding Scale will be completed via a mobile communication platform, and the research will be concluded. Both the control and experimental groups will receive routine breastfeeding support during their hospital stay, within the framework of baby-friendly hospital practices. However, breastfeeding support will not be continued after discharge for the control group.
Experimental Group:
Women participating in the experimental group will complete the Informed Consent Form, Personal Data Collection Form, Breastfeeding Self-Efficacy Scale, and Hospital Depression and Anxiety Scale. After discharge, sustainable and individualized breastfeeding support will be provided to the experimental group by a midwife via a mobile communication network. During their hospital stay, the first endorphin massage will be performed by the researcher for 10-15 minutes, and the partner will also be taught how to do it. Before discharge, the partner will be asked to perform the endorphin massage again, and the endorphin massage performed by the partner will be observed by the researcher. Any missing questions or questions the partner may have will be answered by the researcher during this process. The participant will be instructed to perform endorphin massage twice a week, once a day for 10-15 minutes, and a reminder message will be sent. Upon discharge, the participant will be given a Massage Follow-up Form prepared by the researcher. The front of the massage follow-up form will contain step-by-step visuals explaining the endorphin massage, and the back will contain a chart for the participant and their partner to mark. Participants will be instructed to mark their answers on the massage follow-up form after each endorphin massage application at home. Women in the experimental group will receive sustainable breastfeeding support from the researcher throughout the research period (from the day of participation until the end of the first month). Sustainable breastfeeding support will be individualized and provided via a mobile communication platform. The woman's information needs regarding breastfeeding and massage will be met, and solutions to any problems she encounters will be offered with a personalized approach, involving both the woman and her partner in the process. Women will be called back to the hospital for a follow-up appointment on the 10th day after discharge (or the first working day if it falls on a weekend) for a face-to-face meeting. Participants will be asked to bring the Breastfeeding Self-Efficacy Forms with them when they come for their follow-up appointment. Participants arriving at the hospital will be asked to complete the Breastfeeding Self-Efficacy Scale, Hospital Depression and Anxiety Scale, and Mother-Infant Bonding Scale via a mobile communication platform by the researcher. One month later, participants will be contacted again by phone to have them complete the Breastfeeding Self-Efficacy Scale, Hospital Depression and Anxiety Scale, and Mother-Infant Bonding Scale again via the mobile communication platform, and the research will conclude.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mersin, Turkey (Türkiye)
- Mersin University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a normal delivery at a State Hospital
- Having given birth for the first time
- Having a normal vaginal delivery
- Having undergone a first or second-degree episiotomy (incision)
- Not having any abnormalities during the delivery process (prolonged labor, meconium aspiration, pathological deceleration, etc.)
- Giving birth to a single child,
- Having a live-born baby,
- The baby being healthy
- The mother and baby being together,
- Neither the mother nor the baby having a chronic illness
- Not having a psychiatric illness and not using psychiatric medication
- Living with one's spouse,
- Having reading, writing, and comprehension skills in Turkish
- Volunteering to participate in the study and signing the informed consent form
- Owning an Android phone
Exclusion Criteria:
- Having undergone an assisted delivery (vacuum, forceps, cesarean section)
- Not being in your first pregnancy
- Developing complications during labor (prolonged labor, meconium aspiration, pathological deceleration, etc.)
- Having undergone a deep episiotomy (incision)
- Giving birth to multiple babies
- Stillbirth
- Having a condition that requires separation from your baby
- Being separated from your spouse
- Having a chronic illness in yourself and your baby
- Having a baby with anomalies
- Having a psychiatric illness and using psychiatric medication
- Lacking reading, writing, and comprehension skills in Turkish
- Refusing to participate in the research
- Not having an Android phone Research Termination Criteria
- Mother or baby being hospitalized
- Partner not applying endorphin massage
- Participant withdrawing from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experiment
The experimental group will receive sustainable and individualized breastfeeding support from a midwife via a mobile communication network after discharge.
During their hospital stay, the women in the experimental group will receive their first endorphin massage from the researcher for 10-15 minutes, and their partners will also be taught how to do it.
Before discharge, the partner will be asked to perform the endorphin massage again, and this will be observed by the researcher.
On the 10th day after discharge, the women will be called back to the hospital for a follow-up interview.
One month later, the participants will be contacted again by phone to have the forms completed again via the mobile communication platform, and the research will conclude.
|
Personalized, individualized breastfeeding support will be provided through the mobile application.
The endorphin massage taught to the spouse by the researcher and requested to be performed on the wife at home after discharge from the hospital.
|
|
No Intervention: Control
Women in the control group will not undergo any intervention and will be called back to the hospital on the 10th day after discharge for postpartum follow-up and a face-to-face interview.
Relevant forms will be completed during the interview.
One month later, participants will be contacted again by phone; the forms will be completed via a mobile communication platform, and the study will be concluded.
Both the control and experimental groups will receive routine breastfeeding support within the framework of baby-friendly hospital practices during their hospital stay.
However, breastfeeding support will not be continued for the control group after discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother-Infant Bonding Scale score
Time Frame: Baseline and 6 weeks postpartum
|
Mother-infant bonding will be assessed using the Mother-Infant Bonding Scale.
Data will be collected between November 2025 and July 2026.
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Baseline and 6 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Scale-Short Form (Prenatal and Postnatal Version) score
Time Frame: Baseline and 6 weeks postpartum
|
Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (Prenatal and Postnatal Version).
Data will be collected between November 2025 and July 2026.
|
Baseline and 6 weeks postpartum
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) score
Time Frame: Baseline and 6 weeks postpartum
|
Maternal emotional status will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Data will be collected between November 2025 and July 2026.
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Baseline and 6 weeks postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aslı EKER, Mersin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endorphin Massage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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