Breast FeedingNCT07726225
The Effects of Sustainable Lactation Support and Partner Endorphin Massage
A study testing Sustainable breastfeeding support and Partner-assisted endorphin massage in people with Breast Feeding, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Sustainable breastfeeding support and Partner-assisted endorphin massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 1 Jul 2026
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Feeding
- Being tested
- Sustainable breastfeeding support, Partner-assisted endorphin massage
- Keywords
- Postpartum, Endorphin Massage, Partner Support, Sustainable Breastfeeding, Bonding, Mood
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainable breastfeeding supportOther
Personalized, individualized breastfeeding support will be provided through the mobile application.
Partner-assisted endorphin massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks postpartum
Secondary outcomes (1)
Breastfeeding Self-Efficacy Scale-Short Form (Prenatal and Postnatal Version) score
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.
Measured: Baseline and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Model description
- Randomized parallel controlled experimental study design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı EKER, Mersin University
- Investigators
- Aslı EKER, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726225
- Sponsor's protocol ID
- Endorphin Massage
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share patient data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07726225
- Acronym / sponsor ID
- Endorphin Massage
- Conditions
- Breast Feeding
- Keywords
- Postpartum, Endorphin Massage, Partner Support, Sustainable Breastfeeding, Bonding, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 24 Jul 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel controlled experimental study design.
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Sustainable breastfeeding support, Other: Partner-assisted endorphin massageThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.)
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Sustainable breastfeeding supportPersonalized, individualized breastfeeding support will be provided through the mobile application. | Other | Experiment |
| Partner-assisted endorphin massageThe endorphin massage taught to the spouse by the researcher and requested to be performed on the wife at home after discharge from the hospital. | Other | Experiment |
Primary outcome
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.
1 secondary outcome
Breastfeeding Self-Efficacy Scale-Short Form (Prenatal and Postnatal Version) score
Time frame: Baseline and 6 weeks postpartum
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 24 Jul 2026.
- Individual participant dataSharing planned: No. There are no plans to share patient data.
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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.
Aslı EKER study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainable breastfeeding support and Partner-assisted endorphin massage in people with Breast Feeding, run by Mersin 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 15 inclusion and 17 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 24 Jul 2026. 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?
Mother-Infant Bonding Scale score (time frame: Baseline and 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.