BreastfeedingHBOMNCT07921485
The Effects of Hypnobreastfeeding and Oxytocin Massage on Breastfeeding
A study testing Hypno-breastfeeding and Oxytocin Massage in people with Breastfeeding and Bonding, run by Sümeyye ALTIPARMAK at 1 site in Turkey (Türkiye).
Trial summary
This study examined whether hypno-breastfeeding and oxytocin massage could improve breastfeeding motivation, mothers' perceptions of their milk supply, mother-to-infant bonding, and uterine recovery after childbirth in first-time mothers. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Bonding, Uterine Involution
- What is being tested?
- Hypno-breastfeeding and Oxytocin Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Mar 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study Inclusion Criteria:
For pregnants;
- Having a healthy singleton pregnancy of 37 weeks and above,
- Having no communication barrier,
- Having no diagnosed psychiatric issues. For puerperants;
- Having a normal delivery,
- Having no complications for herself and her baby in the postpartum period,
- Having consumed no herbal or other food/beverage to support breastfeeding in the postpartum period,
- Having no barriers to breastfeeding in the postpartum period (having a newborn in intensive care, having skin issues such as nipple cracks and inverted nipples, etc.),
- Having no communication barrier,
- Having no diagnosed psychiatric issues. Study Exclusion Criteria; For pregnants;
- Having developed cesarean section indication in delivery. For puerperants;
- Having any condition causing her to be separated from her baby in the postpartum period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital - Women's, Maternity and Children's Hospital
Malatya, Malatya, 44280
About this study
Official title: The Effect of Hypno-breastfeeding and Oxytocin Massage on Breastfeeding Motivation, Perceived Insufficient Milk Supply, Mother-to-Infant Bonding and Uterus Involution in Primiparas: A Randomized Controlled Trial
This study examined whether hypno-breastfeeding and oxytocin massage could improve breastfeeding motivation, mothers' perceptions of their milk supply, mother-to-infant bonding, and uterine recovery after childbirth in first-time mothers.
The study included 270 women at a public hospital in eastern Türkiye between September 2020 and March 2021. Participants were divided into three groups of 90 women each.
Read more
Women in the hypno-breastfeeding group received guidance on relaxation, positive affirmations, imagination, and visualization during late pregnancy and after childbirth. Women in the oxytocin massage group received two back massage sessions after childbirth. Women in the control group received routine care without either of these additional interventions.
On the first day after childbirth, the researchers assessed breastfeeding motivation, perceived milk supply, mother-to-infant bonding, and uterine recovery to compare the three groups.
Read the detailed description
This study was conducted using a three-arm experimental design with a post-test control group at a public hospital in eastern Türkiye between September 2020 and March 2021. Data were collected by the researcher through face-to-face interviews with pregnant women attending the non-stress test (NST) unit and postpartum women admitted to the puerperal ward.
The study included 270 primiparous women, with 90 participants in each of three groups: hypno-breastfeeding, oxytocin massage, and routine care.
Pregnant women were recruited into the hypno-breastfeeding group according to their order of arrival at the NST unit. Postpartum women were assigned to the oxytocin massage or control group using a computer-based randomization procedure. A total of 180 numbered positions were generated for these two groups, with 90 women allocated to each group. Participants in the oxytocin massage and control groups were recruited from separate rooms to reduce the risk of infection.
The hypno-breastfeeding intervention began at 37-38 weeks of gestation and was repeated at 39-40 weeks. Participants received education and guidance on positive affirmations, relaxation, imagination, and visualization techniques, supported by educational materials, home exercises, telephone calls, and text messages. Two additional hypno-breastfeeding sessions were provided on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth.
Participants in the oxytocin massage group received two massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment, focusing on the back and spinal region around the fifth and sixth ribs.
Participants in the control group received routine postpartum care without the study-specific hypno-breastfeeding or oxytocin massage interventions.
Outcome assessments were performed on the first postpartum day before hospital discharge. Breastfeeding motivation, perceived milk supply, and mother-to-infant bonding were evaluated using standardized questionnaires. Uterine recovery was assessed by measuring the distance between the uterine fundus and the symphysis pubis with a measuring tape after bladder emptying.
- Conditions
- Breastfeeding, Bonding, Uterine Involution
- Being tested
- Hypno-breastfeeding, Oxytocin Massage
- Keywords
- breastfeeding, Mother-Infant Bonding, Postpartum Uterine Involution
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypno-breastfeedingBehavioural
The hypno-breastfeeding intervention was initiated at 37-38 weeks of gestation and repeated at 39-40 weeks during visits to the non-stress test (NST) unit. Participants received education and guidance on relaxation, positive affirmations, imagination, and visualization techniques to support breastfeeding. Educational brochures and home exercises were provided, and participants were supported through telephone calls and text messages. On the first postpartum day, two additional hypno-breastfeeding sessions were conducted: one before the first breastfeeding session and another between 16 and 20 hours after childbirth.
Oxytocin MassageOther
Participants received two oxytocin massage sessions on the first postpartum day. The first session was administered before the first breastfeeding session, and the second session was conducted between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment. Participants were seated in a forward-leaning position with their head resting on their arms or a table. Massage was applied to the back along the spinal region, particularly around the level of the fifth and sixth ribs, to support breastfeeding and postpartum recovery.
| Study group | Role | What they receive |
|---|---|---|
| Hypno-breastfeeding Group | Experimental | Participants received hypno-breastfeeding education and practice sessions during late pregnancy and on the first postpartum day. The intervention included relaxation, positive affirmations, imagination, and visualization techniques. Receives: Behavioral: Hypno-breastfeeding |
| Oxytocin Massage Group | Experimental | Participants received two oxytocin massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. Receives: Other: Oxytocin Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Motivation Assessed Using the Primiparous Breastfeeding Motivation Scale (PBMS)
Breastfeeding motivation was assessed using the Primiparous Breastfeeding Motivation Scale (PBMS). Items are rated on a 7-point Likert scale. Subscale scores are calculated and interpreted separately, with higher scores indicating higher levels of the corresponding breastfeeding motivation dimension. No overall cut-off score is used.
Measured: Postpartum day 1, before hospital discharge.
Perceived Milk Supply Adequacy Assessed Using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ)
Perceived milk supply adequacy was evaluated using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ). Total scores range from 0 to 50, with higher scores indicating greater perceived milk supply adequacy and lower perceived insufficient milk supply.
Measured: Postpartum day 1, before hospital discharge.
Mother-to-Infant Bonding Assessed Using the Mother-to-Infant Bonding Scale (MIBS)
Mother-to-infant bonding was assessed using the Mother-to-Infant Bonding Scale (MIBS). Total scores range from 0 to 24, with higher scores indicating greater difficulties in mother-to-infant bonding.
Measured: Postpartum day 1, before hospital discharge.
Postpartum Uterine Fundal Height Measured Using the Uterine Involution Assessment Form (UIAF)
Postpartum uterine involution was assessed using a researcher-developed Uterine Involution Assessment Form (UIAF). After the participant emptied her bladder, the distance between the uterine fundus and the symphysis pubis was measured in centimeters using a measuring tape. The same measuring tape was used for all assessments. The recorded measurement represented uterine fundal height on the first postpartum day.
Measured: Postpartum day 1, before hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Hypno-breastfeeding Group: 90 women Oxytocin Massage Group: 90 women Control Group: 90 women
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyye ALTIPARMAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye ALTIPARMAK, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921485
- Sponsor's protocol ID
- HBOM-2020-001
- Acronym
- HBOM
- Status last verified
- Mar 2021
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers due to participant confidentiality and privacy considerations. The study data will be retained and managed in accordance with the approved research protocol and applicable ethical requirements.
Publications
References 1. J. Stockdale, M. Sinclair, G. Kernohan, et al. Understanding motivational theory and the psychology of breastfeeding. In: Bryar R, Sinclair M (eds), Theory for midwifery practice: Palgrave Macmillan, 2011. 2. J. Stockdale, M. Sinclair, G. Kernohan, et al. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers, PloS one 2013;8(12), e82976. 3. E. Koc, S. Ruzgar, S. Ozturk Altinayak, Determination of Factors affecting lactating women's perceptions of ınsufficient milk and the foods they use to ıncrease breast milk, Bezmialem Science 2024;12(3):280-7. https://doi.org/10.14235/bas.galenos.2024.56933 4. S.G. Caliskan, S. Altinkaynak, I'm Breastfeeding My Baby Doesn't Get Enough: Perception of Insufficient Milk, Sakarya University Journal of Holistic Health 2019;2(2), 1-9. 5. S. Ucan, The Effect of Breastfeeding Education Given to Parents on Breastfeeding Process, Cultural Behaviors and Parent-Infant Attachment. Institute of Health Sciences, Department of Public Health. PhD Thesis, Konya: Selcuk University, 2016. 6. E. Bianciardi, F. Ongaretto, A. De Stefano, et al., The mother-baby bond: Role of past and current relationships, Children 2023;10(3), 421. https://doi.org/10.3390/children10030421 7. G. Bosmans, L. Van Vlierberghe, M.J. Bakermans-Kranenburg, et al., A learning theory approach to attachment theory: Exploring clinical applications, Clinical child and family psychology review 2022;25(3), 591-612. https://doi.org/10.1007/s10567-021-00377-x 8. S. Topal, N. Çınar, S. Altınkaynak, Maternal Health Benefits of Breastfeeding, Journal of Human Rhythm 2017;3(1), 25-31. 9. K.A. Uctu, N. Ozerdoğan, Effect of teach-back method on breastfeeding success: A single blind randomized controlled study, Health Care for Women International 2023;44:3, 314-327, https://doi.org/10.1080/07399332.2021.201915 10. N. Irmak, Importance of breast milk and factors affecting exclusive breastfeeding for the first 6 months,
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypno-breastfeeding and Oxytocin Massage on Breastfeeding Motivation, Perceived Insufficient Milk Supply, Mother-to-Infant Bonding and Uterus Involution in Primiparas: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921485
- Acronym / sponsor ID
- HBOM / HBOM-2020-001
- Conditions
- Breastfeeding, Bonding, Uterine Involution
- Keywords
- breastfeeding, Mother-Infant Bonding, Postpartum Uterine Involution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Sümeyye ALTIPARMAKUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 Nov 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.
This study examined whether hypno-breastfeeding and oxytocin massage could improve breastfeeding motivation, mothers' perceptions of their milk supply, mother-to-infant bonding, and uterine recovery after childbirth in first-time mothers.
The study included 270 women at a public hospital in eastern Türkiye between September 2020 and March 2021. Participants were divided into three groups of 90 women each.
Women in the hypno-breastfeeding group received guidance on relaxation, positive affirmations, imagination, and visualization during late pregnancy and after childbirth. Women in the oxytocin massage group received two back massage sessions after childbirth. Women in the control group received routine care without either of these additional interventions.
On the first day after childbirth, the researchers assessed breastfeeding motivation, perceived milk supply, mother-to-infant bonding, and uterine recovery to compare the three groups.
Detailed description
This study was conducted using a three-arm experimental design with a post-test control group at a public hospital in eastern Türkiye between September 2020 and March 2021. Data were collected by the researcher through face-to-face interviews with pregnant women attending the non-stress test (NST) unit and postpartum women admitted to the puerperal ward.
The study included 270 primiparous women, with 90 participants in each of three groups: hypno-breastfeeding, oxytocin massage, and routine care.
Pregnant women were recruited into the hypno-breastfeeding group according to their order of arrival at the NST unit. Postpartum women were assigned to the oxytocin massage or control group using a computer-based randomization procedure. A total of 180 numbered positions were generated for these two groups, with 90 women allocated to each group. Participants in the oxytocin massage and control groups were recruited from separate rooms to reduce the risk of infection.
The hypno-breastfeeding intervention began at 37-38 weeks of gestation and was repeated at 39-40 weeks. Participants received education and guidance on positive affirmations, relaxation, imagination, and visualization techniques, supported by educational materials, home exercises, telephone calls, and text messages. Two additional hypno-breastfeeding sessions were provided on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth.
Participants in the oxytocin massage group received two massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment, focusing on the back and spinal region around the fifth and sixth ribs.
Participants in the control group received routine postpartum care without the study-specific hypno-breastfeeding or oxytocin massage interventions.
Outcome assessments were performed on the first postpartum day before hospital discharge. Breastfeeding motivation, perceived milk supply, and mother-to-infant bonding were evaluated using standardized questionnaires. Uterine recovery was assessed by measuring the distance between the uterine fundus and the symphysis pubis with a measuring tape after bladder emptying.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypno-breastfeeding Group: 90 women Oxytocin Massage Group: 90 women Control Group: 90 women
| Arm | Type | Receives |
|---|---|---|
| Hypno-breastfeeding Group | Experimental | Behavioral: Hypno-breastfeedingParticipants received hypno-breastfeeding education and practice sessions during late pregnancy and on the first postpartum day. The intervention included relaxation, positive affirmations, imagination, and visualization techniques. |
| Oxytocin Massage Group | Experimental | Other: Oxytocin MassageParticipants received two oxytocin massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Hypno-breastfeedingThe hypno-breastfeeding intervention was initiated at 37-38 weeks of gestation and repeated at 39-40 weeks during visits to the non-stress test (NST) unit. Participants received education and guidance on relaxation, positive affirmations, imagination, and visualization techniques to support breastfeeding. Educational brochures and home exercises were provided, and participants were supported through telephone calls and text messages. On the first postpartum day, two additional hypno-breastfeeding sessions were conducted: one before the first breastfeeding session and another between 16 and 20 hours after childbirth. | Behavioural | Hypno-breastfeeding Group |
| Oxytocin MassageParticipants received two oxytocin massage sessions on the first postpartum day. The first session was administered before the first breastfeeding session, and the second session was conducted between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment. Participants were seated in a forward-leaning position with their head resting on their arms or a table. Massage was applied to the back along the spinal region, particularly around the level of the fifth and sixth ribs, to support breastfeeding and postpartum recovery. | Other | Oxytocin Massage Group |
Primary outcome
Breastfeeding Motivation Assessed Using the Primiparous Breastfeeding Motivation Scale (PBMS)
Time frame: Postpartum day 1, before hospital discharge.
Breastfeeding motivation was assessed using the Primiparous Breastfeeding Motivation Scale (PBMS). Items are rated on a 7-point Likert scale. Subscale scores are calculated and interpreted separately, with higher scores indicating higher levels of the corresponding breastfeeding motivation dimension. No overall cut-off score is used.
Perceived Milk Supply Adequacy Assessed Using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ)
Time frame: Postpartum day 1, before hospital discharge.
Perceived milk supply adequacy was evaluated using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ). Total scores range from 0 to 50, with higher scores indicating greater perceived milk supply adequacy and lower perceived insufficient milk supply.
Mother-to-Infant Bonding Assessed Using the Mother-to-Infant Bonding Scale (MIBS)
Time frame: Postpartum day 1, before hospital discharge.
Mother-to-infant bonding was assessed using the Mother-to-Infant Bonding Scale (MIBS). Total scores range from 0 to 24, with higher scores indicating greater difficulties in mother-to-infant bonding.
Postpartum Uterine Fundal Height Measured Using the Uterine Involution Assessment Form (UIAF)
Time frame: Postpartum day 1, before hospital discharge.
Postpartum uterine involution was assessed using a researcher-developed Uterine Involution Assessment Form (UIAF). After the participant emptied her bladder, the distance between the uterine fundus and the symphysis pubis was measured in centimeters using a measuring tape. The same measuring tape was used for all assessments. The recorded measurement represented uterine fundal height on the first postpartum day.
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 6 Nov 2026.
- BackgroundReferences 1. J. Stockdale, M. Sinclair, G. Kernohan, et al. Understanding motivational theory and the psychology of breastfeeding. In: Bryar R, Sinclair M (eds), Theory for midwifery practice: Palgrave Macmillan, 2011. 2. J. Stockdale, M. Sinclair, G. Kernohan, et al. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers, PloS one 2013;8(12), e82976. 3. E. Koc, S. Ruzgar, S. Ozturk Altinayak, Determination of Factors affecting lactating women's perceptions of ınsufficient milk and the foods they use to ıncrease breast milk, Bezmialem Science 2024;12(3):280-7. https://doi.org/10.14235/bas.galenos.2024.56933 4. S.G. Caliskan, S. Altinkaynak, I'm Breastfeeding My Baby Doesn't Get Enough: Perception of Insufficient Milk, Sakarya University Journal of Holistic Health 2019;2(2), 1-9. 5. S. Ucan, The Effect of Breastfeeding Education Given to Parents on Breastfeeding Process, Cultural Behaviors and Parent-Infant Attachment. Institute of Health Sciences, Department of Public Health. PhD Thesis, Konya: Selcuk University, 2016. 6. E. Bianciardi, F. Ongaretto, A. De Stefano, et al., The mother-baby bond: Role of past and current relationships, Children 2023;10(3), 421. https://doi.org/10.3390/children10030421 7. G. Bosmans, L. Van Vlierberghe, M.J. Bakermans-Kranenburg, et al., A learning theory approach to attachment theory: Exploring clinical applications, Clinical child and family psychology review 2022;25(3), 591-612. https://doi.org/10.1007/s10567-021-00377-x 8. S. Topal, N. Çınar, S. Altınkaynak, Maternal Health Benefits of Breastfeeding, Journal of Human Rhythm 2017;3(1), 25-31. 9. K.A. Uctu, N. Ozerdoğan, Effect of teach-back method on breastfeeding success: A single blind randomized controlled study, Health Care for Women International 2023;44:3, 314-327, https://doi.org/10.1080/07399332.2021.201915 10. N. Irmak, Importance of breast milk and factors affecting exclusive breastfeeding for the first 6 months,
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers due to participant confidentiality and privacy considerations. The study data will be retained and managed in accordance with the approved research protocol and applicable ethical requirements.
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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 Hypno-breastfeeding and Oxytocin Massage in people with Breastfeeding and Bonding, run by Sümeyye ALTIPARMAK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 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?
Breastfeeding Motivation Assessed Using the Primiparous Breastfeeding Motivation Scale (PBMS) (time frame: Postpartum day 1, before hospital discharge.). The study lists 4 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 NCT07921485, which also lists 1 linked publication.
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 6 Nov 2026.