The Effects of Sustainable Lactation Support and Partner Endorphin Massage

NCT07726225 | Completed

• 1 other identifier: Endorphin Massage
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Feeding

Keywords

Postpartum; Endorphin Massage; Partner Support; Sustainable Breastfeeding; Bonding; Mood

Outcome Measures

Primary Outcomes (1)

• Mother-Infant Bonding Scale score

  Mother-infant bonding will be assessed using the Mother-Infant Bonding Scale. Data will be collected between November 2025 and July 2026.

  Baseline and 6 weeks postpartum

Secondary Outcomes (1)

• Breastfeeding Self-Efficacy Scale-Short Form (Prenatal and Postnatal Version) score

  Baseline and 6 weeks postpartum

Other Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS) score

  Baseline and 6 weeks postpartum

Study Arms (2)

Experiment

EXPERIMENTAL

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.

Other: Sustainable breastfeeding support; Other: Partner-assisted endorphin massage

Control

NO INTERVENTION

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.

Interventions

Sustainable breastfeeding support OTHER

Personalized, individualized breastfeeding support will be provided through the mobile application.

Experiment

Partner-assisted endorphin massage OTHER

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.

Experiment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Aslı EKER

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be performed using a sealed envelope method.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Model Details: Randomized parallel controlled experimental study design.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: July 24, 2026
• Study Start: November 15, 2025
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)