HaptonomyHaptonomyNCT07403240
The Effect of Haptonomy Practice on Risk Perception, Distress and Attachment in Pregnant Women With Prenatal Loss
A study testing Haptonomy in people with Haptonomy and Prenatal Loss, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted to determine the effects of haptonomy application given to pregnant women who experienced prenatal loss on risk perception, distress and attachment. The sample of this randomized controlled study consisted of 126 pregnant women, 63 in the experimental group and 63 in the control group, who… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Haptonomy, Prenatal Loss
- What is being tested?
- Haptonomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Having a single and live pregnancy,
- Pregnant women between 24 and 32 weeks of gestation, which is considered a suitable period for the application of haptonomy,
- No maternal-fetal risks associated with pregnancy (preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, fetal anomaly, intrauterine growth retardation, etc.),
- Having previously experienced prenatal loss,
- Pregnant women who agreed to participate in the study were included in the study.
Who cannot join
- Getting pregnant with assisted reproductive techniques,
- Those with limited communication and perception skills,
- Pregnant women who were not between 24-32 weeks of gestation were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The research was conducted to determine the effects of haptonomy application given to pregnant women who experienced prenatal loss on risk perception, distress and attachment. The sample of this randomized controlled study consisted of 126 pregnant women, 63 in the experimental group and 63 in the control group, who applied to the Diyarbakır Ergani State Hospital Gynecology and Obstetrics Clinic and who had experienced at least one prenatal loss and were in the 24-32nd week of pregnancy. Data were obtained using the "Personal Introduction Form", "Perception of Pregnancy Risk Scale (PPRS)", "Tilburg Pregnancy Distress Scale (TPDS)" and "Prenatal Attachment Inventory (PAI)". Haptonomics were performed in 5 interviews at 7-10 day intervals with music determined by the researcher and the pregnant woman.
Read the detailed description
This randomized controlled study was carried out to examine the effects of haptonomy on risk perception, psychological distress, and prenatal attachment among pregnant women who had experienced prenatal loss. The study population consisted of pregnant women between 24 and 32 weeks of gestation who had a history of prenatal loss. A total of 126 eligible participants were enrolled and randomly allocated into intervention and control groups.
Participants in the intervention group received haptonomy sessions conducted by the researcher, accompanied by music selected collaboratively with the pregnant woman. The intervention consisted of five sessions performed at intervals of 7-10 days. The control group received routine prenatal follow-up care without any additional intervention.
Data collection tools included a Personal Information Form, the Pregnancy Risk Perception Scale (PRPS), the Tilburg Pregnancy Distress Scale (TPDS), and the Prenatal Attachment Inventory (PAI).
- Conditions
- Haptonomy, Prenatal Loss
- Being tested
- Haptonomy
- Keywords
- Distress, Midwife, Risk perception in pregnancy, Haptonomy, Prenatal attachment, Prenatal loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaptonomyBehavioural
Haptonomy intervention was conducted by the researcher and consisted of five sessions delivered at 7-10 day intervals. Sessions were performed with pregnant women who had experienced prenatal loss, accompanied by music selected collaboratively by the researcher and the participant.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In this phase of the research, a midwifery intervention was implemented within the scope of "Haptonomy", consisting of a total of five stages, each lasting between 30 and 90 minutes. Receives: Behavioral: Haptonomy |
| control group | No intervention | The control group received no intervention and received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Perceived Pregnancy Risk Scale Score"
Following the haptonomy intervention, pregnancy risk perception levels were examined using the Perceived Pregnancy Risk Scale (PPRS). The scale consists of 9 items rated on a 0-100 mm visual analogue scale (0 = no risk, 100 = extreme risk).Each item was scored by measuring the distance in millimeters from the left anchor to the participant's mark, resulting in an item score ranging from 0 to 100. The total score is calculated by summing all nine items and dividing by nine.The scale has two subscales: Risk to the baby (5 items: items 2, 6, 7, 8, 9) and Risk to the self (4 items: items 1, 3, 4, 5). Subscale scores are calculated by summing the items in that subscale and dividing by the number of items in that subscale.Total score range: 0 to 100. Subscale score range: 0 to 100 for each subscale. There is no cut-off score. Higher scores indicate higher perceived pregnancy risk, which is considered a worse outcome.
Measured: Baseline and 5 months after intervention
Secondary outcomes (2)
Tilburg Pregnancy Distress Scale Total Score
The level of psychological distress experienced during pregnancy will be assessed using the Tilburg Pregnancy Distress Scale (TPDS). The scale consists of 16 items rated on a 4-point Likert scale (0 = very often, 1 = quite often, 2 = sometimes, 3 = rarely or never). Items 3, 5, 7, 9-14, and 16 are reverse scored.The scale has two subscales: Negative Affect (11 items) and Partner Involvement (5 items). The total score is calculated by summing all 16 items.Total score range: 0 to 48. Negative Affect subscale score range: 0 to 33. Partner Involvement subscale score range: 0 to 15. A cut-off score of ≥28 indicates that the pregnant woman is at risk for pregnancy-related distress. Higher scores indicate higher pregnancy-related distress, which is considered a worse outcome.
Measured: Baseline and 5 months after intervention
Prenatal Attachment Inventory Total Score
The prenatal attachment level will be assessed using the Prenatal Attachment Inventory. The inventory consists of 21 items rated on a 4-point Likert scale (1= never, 2= sometimes, 3= often, 4= always). The total score ranges from 21 to 84, with higher scores indicating higher levels of prenatal attachment.
Measured: Baseline and 5 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start20 Sep 2023
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HaptonomyStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP KALKAN, Inonu University
- Investigators
- ZEYNEP KALKAN, MİDWİFERY, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403240
- Sponsor's protocol ID
- 2023/4971
- Acronym
- Haptonomy
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Haptonomy Practice on Risk Perception, Distress and Attachment in Pregnant Women With Prenatal Loss
- ClinicalTrials.gov ID
- NCT07403240
- Acronym / sponsor ID
- Haptonomy / 2023/4971
- Conditions
- Haptonomy, Prenatal Loss
- Keywords
- Distress, Midwife, Risk perception in pregnancy, Haptonomy, Prenatal attachment, Prenatal loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research was conducted to determine the effects of haptonomy application given to pregnant women who experienced prenatal loss on risk perception, distress and attachment. The sample of this randomized controlled study consisted of 126 pregnant women, 63 in the experimental group and 63 in the control group, who applied to the Diyarbakır Ergani State Hospital Gynecology and Obstetrics Clinic and who had experienced at least one prenatal loss and were in the 24-32nd week of pregnancy. Data were obtained using the "Personal Introduction Form", "Perception of Pregnancy Risk Scale (PPRS)", "Tilburg Pregnancy Distress Scale (TPDS)" and "Prenatal Attachment Inventory (PAI)". Haptonomics were performed in 5 interviews at 7-10 day intervals with music determined by the researcher and the pregnant woman.
Detailed description
This randomized controlled study was carried out to examine the effects of haptonomy on risk perception, psychological distress, and prenatal attachment among pregnant women who had experienced prenatal loss. The study population consisted of pregnant women between 24 and 32 weeks of gestation who had a history of prenatal loss. A total of 126 eligible participants were enrolled and randomly allocated into intervention and control groups.
Participants in the intervention group received haptonomy sessions conducted by the researcher, accompanied by music selected collaboratively with the pregnant woman. The intervention consisted of five sessions performed at intervals of 7-10 days. The control group received routine prenatal follow-up care without any additional intervention.
Data collection tools included a Personal Information Form, the Pregnancy Risk Perception Scale (PRPS), the Tilburg Pregnancy Distress Scale (TPDS), and the Prenatal Attachment Inventory (PAI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: HaptonomyIn this phase of the research, a midwifery intervention was implemented within the scope of "Haptonomy", consisting of a total of five stages, each lasting between 30 and 90 minutes. |
| control group | No intervention | –The control group received no intervention and received routine care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Having a single and live pregnancy,
- Pregnant women between 24 and 32 weeks of gestation, which is considered a suitable period for the application of haptonomy,
- No maternal-fetal risks associated with pregnancy (preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, fetal anomaly, intrauterine growth retardation, etc.),
- Having previously experienced prenatal loss,
- Pregnant women who agreed to participate in the study were included in the study.
Key exclusion criteria (3 listed)
- Getting pregnant with assisted reproductive techniques,
- Those with limited communication and perception skills,
- Pregnant women who were not between 24-32 weeks of gestation were excluded from the 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 |
|---|---|---|
| HaptonomyHaptonomy intervention was conducted by the researcher and consisted of five sessions delivered at 7-10 day intervals. Sessions were performed with pregnant women who had experienced prenatal loss, accompanied by music selected collaboratively by the researcher and the participant. | Behavioural | experimental group |
Primary outcome
"Perceived Pregnancy Risk Scale Score"
Time frame: Baseline and 5 months after intervention
Following the haptonomy intervention, pregnancy risk perception levels were examined using the Perceived Pregnancy Risk Scale (PPRS). The scale consists of 9 items rated on a 0-100 mm visual analogue scale (0 = no risk, 100 = extreme risk).Each item was scored by measuring the distance in millimeters from the left anchor to the participant's mark, resulting in an item score ranging from 0 to 100. The total score is calculated by summing all nine items and dividing by nine.The scale has two subscales: Risk to the baby (5 items: items 2, 6, 7, 8, 9) and Risk to the self (4 items: items 1, 3, 4, 5). Subscale scores are calculated by summing the items in that subscale and dividing by the number of items in that subscale.Total score range: 0 to 100. Subscale score range: 0 to 100 for each subscale. There is no cut-off score. Higher scores indicate higher perceived pregnancy risk, which is considered a worse outcome.
2 secondary outcomes
Tilburg Pregnancy Distress Scale Total Score
Time frame: Baseline and 5 months after intervention
Prenatal Attachment Inventory Total Score
Time frame: Baseline and 5 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- haptonomyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Haptonomy
Not yet recruiting
Prenatal Haptonomy-Based Support for Attachment and Partner Support
Maternal-Fetal Attachment, Perceived Partner Support
Not yet recruiting
The Effect of Haptonomy Practice on Body Functionality Appreciation and Childbirth Self-Efficacy in Pregnant Women
Pregnant Women
Recruiting
Effect of Haptonomy on Prenatal Attachment and Fear of Childbirth in Primiparous Couples
Fear of Childbirth, Prenatal Attachment
Enrolling by invitation
The Effect of Haptonomy and Conscious Awareness Applied to Pregnant Women on Prenatal Breastfeeding Self-efficacy and Infant Feeding Attitudes
Pregnancy
Not yet recruiting
The Effect of Mindfulness-Based Intervention and Haptonomy Application on Birth Self-Efficacy, Prenatal Attachment and Anxiety Levels of Pregnant Women With Fear of ChildBirth
Fear of Childbirth, Haptonomy
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.
ZEYNEP KALKAN, MİDWİFERY principal investigator
Inonu 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 Haptonomy in people with Haptonomy and Prenatal Loss, run by Inonu 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 5 inclusion and 3 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 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?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
"Perceived Pregnancy Risk Scale Score" (time frame: Baseline and 5 months after intervention). 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 6 Nov 2026.