Maternal-Fetal AttachmentNCT07417384
Prenatal Haptonomy-Based Support for Attachment and Partner Support
A study testing Prenatal Haptonomy-Based Support, Mother-Supported Haptonomy Group and Midwife-Supported Haptonomy Group in people with Maternal-Fetal Attachment and Perceived Partner Support, run by Hilal Özbek.
Trial summary
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027. 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
- Maternal-Fetal Attachment, Perceived Partner Support, Haptonomy
- What is being tested?
- Prenatal Haptonomy-Based Support, Mother-Supported Haptonomy Group and Midwife-Supported Haptonomy Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pregnant women aged 18-45 years
- Attending antenatal follow-up at Tokat Gaziosmanpaşa University Hospital
- Gestational age between 20 and 32 weeks
- Ability to communicate in Turkish
- Willingness to participate and provide written informed consent
Who cannot join
- High-risk pregnancy (e.g., preeclampsia, placenta previa, gestational diabetes requiring insulin)
- Diagnosed psychiatric disorder
- Multiple pregnancy
- Known fetal anomaly
- Participation in another interventional study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Simay Bartınlı, Msc contact
About this study
Official title: Effects of Haptonomy-Based Support Approaches in the Prenatal Period on Prenatal Attachment and Perceived Partner Support - A Randomized Controlled Study
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027.
Eligible participants will be informed about the study objectives, procedures, potential benefits and risks, and voluntary participation principles. Written informed consent will be obtained prior to enrollment. Participant confidentiality will be ensured in accordance with data protection regulations, and unique identification codes will be assigned.
Read more
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory (PAI), and Spousal Support Scale (SSS). Following baseline assessment, participants will be randomly allocated into one of three groups:
Partner-supported haptonomy group Mother-supported haptonomy group Midwife-supported haptonomy group The haptonomy-based intervention will be delivered once weekly for three consecutive weeks in a hospital-based setting. Each session will last approximately 30 minutes and will follow a standardized protocol including structured affective touch, body awareness facilitation, emotional observation, and structured session closure. All sessions will be conducted by a research assistant who completed the Prenatal Haptonomy Instructor Training (January 29-31, 2026). The principal investigator will supervise and monitor the scientific integrity of the study.
Outcome assessments will be conducted at three time points:
T0 (Baseline): Prior to intervention T1 (Post-session 1): 24-48 hours after the first haptonomy session T2 (Post-intervention): 24-48 hours after the third haptonomy session The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Data completeness will be checked after each assessment.
Read the detailed description
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027. Participants will receive verbal and written information about the study, written informed consent will be obtained, and all data will be stored using coded identifiers in accordance with confidentiality principles.
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory, and Spousal Support Scale. Participants will then be randomly assigned to one of three groups: partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy. The haptonomy-based intervention will be delivered over three consecutive weeks, once per week, following a standardized protocol, with each session lasting approximately 30 minutes and conducted in a hospital setting. Interventions will be carried out by a research assistant trained in prenatal haptonomy and scientifically supervised by the principal investigator.
Haptonomy sessions will include structured affective touch, body awareness facilitation, emotional observation, and session closure, with no invasive procedures involved. Outcome assessments will be conducted at three time points: prior to the intervention (T0), 24-48 hours after the first session (T1), and 24-48 hours after the third session (T2). The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Collected data will be analyzed using statistical methods to evaluate the effects of haptonomy-based support approaches on prenatal attachment and perceived partner support.
- Being tested
- Prenatal Haptonomy-Based Support, Mother-Supported Haptonomy Group, Midwife-Supported Haptonomy Group
- Keywords
- Haptonomy, Prenatal Haptonomy, Prenatal Attachment, Maternal-Fetal Attachment, Partner Support; Pregnancy, Randomized Controlled Trial, Psychosocial Intervention, Partner Support, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Haptonomy-Based SupportBehavioural
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's partner. The protocol includes affective touch facilitated by the partner, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.
Mother-Supported Haptonomy GroupBehavioural
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's mother. The protocol includes affective touch facilitated by the mother, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.
Midwife-Supported Haptonomy GroupBehavioural
A structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted by a trained midwife. The protocol includes affective touch provided by the midwife, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Partner-Supported Haptonomy Group | Experimental | Pregnant women receiving haptonomy-based prenatal support together with their partners once weekly for three consecutive weeks. Receives: Behavioral: Prenatal Haptonomy-Based Support |
| Mother-Supported Haptonomy Group | Experimental | Pregnant women receiving haptonomy-based prenatal support together with their mothers once weekly for three consecutive weeks. Receives: Behavioral: Mother-Supported Haptonomy Group |
| Midwife-Supported Haptonomy Group | Experimental | Pregnant women receiving haptonomy-based prenatal support delivered by a trained midwife once weekly for three consecutive weeks. Receives: Behavioral: Midwife-Supported Haptonomy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Attachment
Change from baseline in prenatal attachment as measured by the Prenatal Attachment Inventory (PAI).
The Prenatal Attachment Inventory (PAI), developed by Mary Muller (1993), consists of 21 items rated on a 4-point Likert scale (1 = Almost Never, 4 = Almost Always).
Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment. There are no reverse-scored items. The scale is unidimensional and evaluated using total score.
Measured: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
Secondary outcomes (1)
Perceived Partner Support
Change from baseline in perceived partner support as measured by the Spouse Support Scale (SSS).
The Spouse Support Scale (SSS), developed by Yıldırım (2005), consists of 13 items rated on a 5-point Likert scale (1 = Not appropriate at all, 5 = Completely appropriate).
Total scores range from 13 to 65. Higher total scores indicate higher perceived partner support. There are no reverse-scored items. The scale is evaluated using the total score.
Measured: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal AttachmentStudies 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
- Single group
- Model description
- Participants will be randomly assigned to one of three parallel groups (partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy) and followed for three weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hilal Özbek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Özbek, Tokat Gaziosmanpasa University
- Investigators
- Hilal Ozbek, Principal investigator, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417384
- Sponsor's protocol ID
- TR TOKAT03
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and institutional data protection policies. Only aggregate study results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Haptonomy-Based Support Approaches in the Prenatal Period on Prenatal Attachment and Perceived Partner Support - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07417384
- Acronym / sponsor ID
- TR TOKAT03
- Keywords
- Haptonomy, Prenatal Haptonomy, Prenatal Attachment, Maternal-Fetal Attachment, Partner Support; Pregnancy, Randomized Controlled Trial, Psychosocial Intervention, Partner Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hilal ÖzbekUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 18 Feb 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 is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027.
Eligible participants will be informed about the study objectives, procedures, potential benefits and risks, and voluntary participation principles. Written informed consent will be obtained prior to enrollment. Participant confidentiality will be ensured in accordance with data protection regulations, and unique identification codes will be assigned.
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory (PAI), and Spousal Support Scale (SSS). Following baseline assessment, participants will be randomly allocated into one of three groups:
Partner-supported haptonomy group Mother-supported haptonomy group Midwife-supported haptonomy group The haptonomy-based intervention will be delivered once weekly for three consecutive weeks in a hospital-based setting. Each session will last approximately 30 minutes and will follow a standardized protocol including structured affective touch, body awareness facilitation, emotional observation, and structured session closure. All sessions will be conducted by a research assistant who completed the Prenatal Haptonomy Instructor Training (January 29-31, 2026). The principal investigator will supervise and monitor the scientific integrity of the study.
Outcome assessments will be conducted at three time points:
T0 (Baseline): Prior to intervention T1 (Post-session 1): 24-48 hours after the first haptonomy session T2 (Post-intervention): 24-48 hours after the third haptonomy session The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Data completeness will be checked after each assessment.
Detailed description
This study is a three-arm randomized controlled trial to be conducted among pregnant women attending the antenatal outpatient clinic of Tokat Gaziosmanpaşa University Hospital who meet the inclusion criteria. Data will be collected between April 1, 2026, and April 30, 2027. Participants will receive verbal and written information about the study, written informed consent will be obtained, and all data will be stored using coded identifiers in accordance with confidentiality principles.
At baseline (T0), participants will complete the Personal Information Form, Prenatal Attachment Inventory, and Spousal Support Scale. Participants will then be randomly assigned to one of three groups: partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy. The haptonomy-based intervention will be delivered over three consecutive weeks, once per week, following a standardized protocol, with each session lasting approximately 30 minutes and conducted in a hospital setting. Interventions will be carried out by a research assistant trained in prenatal haptonomy and scientifically supervised by the principal investigator.
Haptonomy sessions will include structured affective touch, body awareness facilitation, emotional observation, and session closure, with no invasive procedures involved. Outcome assessments will be conducted at three time points: prior to the intervention (T0), 24-48 hours after the first session (T1), and 24-48 hours after the third session (T2). The Prenatal Attachment Inventory and Spousal Support Scale will be re-administered at T1 and T2. Collected data will be analyzed using statistical methods to evaluate the effects of haptonomy-based support approaches on prenatal attachment and perceived partner support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups (partner-supported haptonomy, mother-supported haptonomy, or midwife-supported haptonomy) and followed for three weeks.
| Arm | Type | Receives |
|---|---|---|
| Partner-Supported Haptonomy Group | Experimental | Behavioral: Prenatal Haptonomy-Based SupportPregnant women receiving haptonomy-based prenatal support together with their partners once weekly for three consecutive weeks. |
| Mother-Supported Haptonomy Group | Experimental | Behavioral: Mother-Supported Haptonomy GroupPregnant women receiving haptonomy-based prenatal support together with their mothers once weekly for three consecutive weeks. |
| Midwife-Supported Haptonomy Group | Experimental | Behavioral: Midwife-Supported Haptonomy GroupPregnant women receiving haptonomy-based prenatal support delivered by a trained midwife once weekly for three consecutive weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women aged 18-45 years
- Attending antenatal follow-up at Tokat Gaziosmanpaşa University Hospital
- Gestational age between 20 and 32 weeks
- Ability to communicate in Turkish
- Willingness to participate and provide written informed consent
Key exclusion criteria (5 listed)
- High-risk pregnancy (e.g., preeclampsia, placenta previa, gestational diabetes requiring insulin)
- Diagnosed psychiatric disorder
- Multiple pregnancy
- Known fetal anomaly
- Participation in another interventional study
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 |
|---|---|---|
| Prenatal Haptonomy-Based SupportA structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's partner. The protocol includes affective touch facilitated by the partner, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. | Behavioural | Partner-Supported Haptonomy Group |
| Mother-Supported Haptonomy GroupA structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted with the participation of the pregnant woman's mother. The protocol includes affective touch facilitated by the mother, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. | Behavioural | Mother-Supported Haptonomy Group |
| Midwife-Supported Haptonomy GroupA structured haptonomy-based prenatal support intervention delivered once weekly for three consecutive weeks. Each session lasts approximately 30 minutes and is conducted by a trained midwife. The protocol includes affective touch provided by the midwife, body awareness facilitation, emotional observation, and structured session closure. The intervention is conducted in a hospital setting. | Behavioural | Midwife-Supported Haptonomy Group |
Primary outcome
Prenatal Attachment
Time frame: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
Change from baseline in prenatal attachment as measured by the Prenatal Attachment Inventory (PAI). The Prenatal Attachment Inventory (PAI), developed by Mary Muller (1993), consists of 21 items rated on a 4-point Likert scale (1 = Almost Never, 4 = Almost Always). Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment. There are no reverse-scored items. The scale is unidimensional and evaluated using total score.
1 secondary outcome
Perceived Partner Support
Time frame: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and institutional data protection policies. Only aggregate study results will be published.
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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.
Simay Bartınlı, Msc contact
Hilal Ozbek principal investigator
Tokat Gaziosmanpasa University
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Haptonomy-Based Support, Mother-Supported Haptonomy Group and Midwife-Supported Haptonomy Group in people with Maternal-Fetal Attachment and Perceived Partner Support, run by Hilal Özbek.
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 5 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilal Ozbek (+905053873773, hilal.ozbek@gop.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Attachment (time frame: Baseline (T0), 24-48 hours after the first haptonomy session (T1), and 24-48 hours after the third haptonomy session (T2)). 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 29 Sep 2026.