Mindfulness-Based Stress ReductionNCT06699550
Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth
A study testing Haptonomy and Mindfulness-Based Stress Reduction Program in people with Mindfulness-Based Stress Reduction, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this project was to examine the effects of haptonomy application and the mindfulness-based stress reduction program (MBSRP) on the psychological well-being levels, perceived stress, and fear of childbirth in primiparous women. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness-Based Stress Reduction
- What is being tested?
- Haptonomy and Mindfulness-Based Stress Reduction Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 1 Oct 2024
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are married and experiencing their first pregnancy.
- Aged 18 years or older.
- Able to read, write, and understand Turkish.
- Residing in the city center where the study is conducted.
- No physical or psychological health issues for themselves or their baby.
- Experiencing a spontaneous pregnancy between 22-28 weeks of gestation.
- Have not previously undergone BFTSAP (Body-Focused Therapy and Support for Anxiety during Pregnancy) and haptonomy applications.
- Pregnant women who agree to participate in the study.
Who cannot join
- Those with a known and diagnosed psychiatric disorder.
- Individuals who have previously undergone cognitive therapy.
- Experiencing severe levels of anxiety, stress, and depression.
- Having chronic diseases (such as hypertension, diabetes mellitus, heart diseases) that existed before or have emerged during pregnancy.
- Individuals who have not attended the first two sessions of the MBSR (Mindfulness-Based Stress Reduction) program and haptonomy applications.
- Lacking a partner or relative who can provide support and assistance at home during the applications.
- Without access to technical technology support.
- Pregnant women who do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Haptonomy Application and Mindfulness-based Stress Reduction Program on Psychological Well-being Levels, Perceived Stress, and Fear of Childbirth in Primiparous Mothers: A Randomized Controlled Trial
Aim: The aim of this project was to examine the effects of haptonomy application and the mindfulness-based stress reduction program (MBSRP) on the psychological well-being levels, perceived stress, and fear of childbirth in primiparous women.
Materials and Methods: This prospective, single-blind, randomized controlled study was conducted between January 1, 2024, and October 1, 2024. A total of 120 primiparous women (40: control group, 40: haptonomy group, and 40: MBSRP group) who volunteered to participate in the study were randomly assigned to three groups: the intervention group (haptonomy and MBSRP) and the control group. The haptonomy and MBSRP groups received individual and face-to-face interventions for 8 weeks. At baseline, the 4th week, and the 8th week, the "Personal Data Collection Form," "Psychological Well-Being Scale," "Perceived Stress Scale," and "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ/A) A version" were administered, based on a literature review.
- Conditions
- Mindfulness-Based Stress Reduction
- Being tested
- Haptonomy, Mindfulness-Based Stress Reduction Program
- Keywords
- Primiparous women, Haptonomy, Mindfulness-based stress reduction program, Psychological well-being, Perceived stress, Fear of childbirth
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaptonomyOther
The session transitioned to energy work and dream visualization. The researcher and the pregnant participant placed their left hands on each other's hearts. The goal was for the participants to feel the energy flowing between them, sense their hearts, open their third eye, and prepare their hands. This exercise aimed to enhance the pregnant participant's confidence in her own emotions and body by recognizing her feelings and physical sensations. Next, the researcher and the pregnant participant placed their right hands on the participant's forehead and their left hands over their hearts. This positioning facilitated the pregnant participant in visually sensing the presence of her baby. It was intended to promote communication between the mother and her baby at both a physical and spiritual level.
Mindfulness-Based Stress Reduction ProgramOther
Also called Mindfulness
Participants were introduced to each other and provided with information related to pregnancy. The Mindfulness-Based Stress Reduction Program (MBSR) was introduced. The participants shared their levels of well-being, stress, coping mechanisms for fear of childbirth, and their expectations from the MBSR program. Awareness of habitual behaviors was facilitated. Afterwards, breath-focused meditation and dried fruit meditation were practiced. Participants were encouraged to maintain awareness of activities performed at any time during the day. Lastly, body scan meditation was taught, and participants were instructed to repeat the practice throughout the week using audio recordings.
| Study group | Role | What they receive |
|---|---|---|
| Haptonomy | Experimental | Haptonomy was conducted individually, both in a prenatal school and at home. At the beginning of the application, information was provided about the definition, purpose, and importance of haptonomy. It was stated that haptonomy would be carried out over 8 weeks, once a week for at least 30 minutes, on days and times of their choosing. In the first 4 weeks, it would be conducted under the guidance of the researchers, while in the following 4 weeks, it would be applied with the help of videos and brochures provided by the researchers, together with their partners. Receives: Other: Haptonomy |
| Mindfulness-Based Stress Reduction Program | Experimental | Participants were introduced to each other and provided with information related to pregnancy. The Mindfulness-Based Stress Reduction Program (MBSR) was introduced. The participants shared their levels of well-being, stress, coping mechanisms for fear of childbirth, and their expectations from the MBSR program. Awareness of habitual behaviors was facilitated. Afterwards, breath-focused meditation and dried fruit meditation were practiced. Participants were encouraged to maintain awareness of activities performed at any time during the day. Lastly, body scan meditation was taught, and participants were instructed to repeat the practice throughout the week using audio recordings sent via WhatsApp. Receives: Other: Mindfulness-Based Stress Reduction Program |
| Control | No intervention | No use intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-Being Scale
The Psychological Well-Being Scale, developed, consists of eight items aimed at measuring psychological well-being levels. The internal consistency coefficient of the scale is 0.87. The Turkish adaptation of the Psychological Well-Being Scale was conducted, who found the internal consistency coefficient to be 0.87 as well. The scale is rated on a 1-7 point scale, with higher scores indicating that the individual possesses psychological strengths.
Measured: change from starting to 4. and 8. week
Perceived Stress Scale
The Perceived Stress Scale, consisting of 14 items, was developed to measure the degree to which individuals perceive certain situations in their lives as stressful. The scale is assessed using a 5-point Likert-type scoring system, ranging from 0 to 4. It comprises two factors: 'perception of stress/discomfort' and 'perception of inadequacy.' The scale allows for a maximum score of 56 and a minimum score of 0, with scores increasing as stress levels rise. The validity and reliability of the scale were established. The Turkish version of the Perceived Stress Scale (PSS-14) has an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87.
Measured: change from starting to 4. and 8. week
Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A
The scale, consists of 33 items. Responses to the items are rated on a scale from 0 to 5, utilizing a six-point Likert-type format. The maximum score attainable on the scale is 165, while the minimum is 0. A higher total score indicates a greater level of fear. Specifically, a scale score of 85 or above reflects clinical levels of birth fear, scores between 66 and 84 indicate severe fear, scores between 38 and 65 denote moderate fear, and scores of 37 and below signify mild levels of birth fear. The Cronbach's alpha coefficient for the scale is found to be 0.88 for first-time mothers (primiparous) and 0.90 for mothers who have given birth before (multiparous).
Measured: change from starting to 4. and 8. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start2 Jan 2024
- Primary completion10 Mar 2024
- Study completion1 Oct 2024
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 Mindfulness-Based Stress ReductionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Bartın Unıversity
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699550
- Sponsor's protocol ID
- 2023-SBB-0435
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kucukkaya B, Ozturk S, Ekrem EC. Comparison of the effects of haptonomy application and mindfulness-based stress reduction on psychological well-being, perceived stress, and fear of childbirth in primiparous women: a randomized controlled trial. BMC Complement Med Ther. 2026 Jul 3. doi: 10.1186/s12906-026-05452-w. Online ahead of print.
PubMed 42399888
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Haptonomy Application and Mindfulness-based Stress Reduction Program on Psychological Well-being Levels, Perceived Stress, and Fear of Childbirth in Primiparous Mothers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06699550
- Acronym / sponsor ID
- 2023-SBB-0435
- Conditions
- Mindfulness-Based Stress Reduction
- Keywords
- Primiparous women, Haptonomy, Mindfulness-based stress reduction program, Psychological well-being, Perceived stress, Fear of childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Bartın Unıversity
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 21 Nov 2024 (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.
Aim: The aim of this project was to examine the effects of haptonomy application and the mindfulness-based stress reduction program (MBSRP) on the psychological well-being levels, perceived stress, and fear of childbirth in primiparous women.
Materials and Methods: This prospective, single-blind, randomized controlled study was conducted between January 1, 2024, and October 1, 2024. A total of 120 primiparous women (40: control group, 40: haptonomy group, and 40: MBSRP group) who volunteered to participate in the study were randomly assigned to three groups: the intervention group (haptonomy and MBSRP) and the control group. The haptonomy and MBSRP groups received individual and face-to-face interventions for 8 weeks. At baseline, the 4th week, and the 8th week, the "Personal Data Collection Form," "Psychological Well-Being Scale," "Perceived Stress Scale," and "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ/A) A version" were administered, based on a literature review.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Haptonomy | Experimental | Other: HaptonomyHaptonomy was conducted individually, both in a prenatal school and at home. At the beginning of the application, information was provided about the definition, purpose, and importance of haptonomy. It was stated that haptonomy would be carried out over 8 weeks, once a week for at least 30 minutes, on days and times of their choosing. In the first 4 weeks, it would be conducted under the guidance of the researchers, while in the following 4 weeks, it would be applied with the help of videos and brochures provided by the researchers, together with their partners. |
| Mindfulness-Based Stress Reduction Program | Experimental | Other: Mindfulness-Based Stress Reduction ProgramParticipants were introduced to each other and provided with information related to pregnancy. The Mindfulness-Based Stress Reduction Program (MBSR) was introduced. The participants shared their levels of well-being, stress, coping mechanisms for fear of childbirth, and their expectations from the MBSR program. Awareness of habitual behaviors was facilitated. Afterwards, breath-focused meditation and dried fruit meditation were practiced. Participants were encouraged to maintain awareness of activities performed at any time during the day. Lastly, body scan meditation was taught, and participants were instructed to repeat the practice throughout the week using audio recordings sent via WhatsApp. |
| Control | No intervention | –No use intervention. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women who are married and experiencing their first pregnancy.
- Aged 18 years or older.
- Able to read, write, and understand Turkish.
- Residing in the city center where the study is conducted.
- No physical or psychological health issues for themselves or their baby.
Key exclusion criteria (8 listed)
- Those with a known and diagnosed psychiatric disorder.
- Individuals who have previously undergone cognitive therapy.
- Experiencing severe levels of anxiety, stress, and depression.
- Having chronic diseases (such as hypertension, diabetes mellitus, heart diseases) that existed before or have emerged during pregnancy.
- Individuals who have not attended the first two sessions of the MBSR (Mindfulness-Based Stress Reduction) program and haptonomy applications.
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 |
|---|---|---|
| HaptonomyThe session transitioned to energy work and dream visualization. The researcher and the pregnant participant placed their left hands on each other's hearts. The goal was for the participants to feel the energy flowing between them, sense their hearts, open their third eye, and prepare their hands. This exercise aimed to enhance the pregnant participant's confidence in her own emotions and body by recognizing her feelings and physical sensations. Next, the researcher and the pregnant participant placed their right hands on the participant's forehead and their left hands over their hearts. This positioning facilitated the pregnant participant in visually sensing the presence of her baby. It was intended to promote communication between the mother and her baby at both a physical and spiritual level. | Other | Haptonomy |
| Mindfulness-Based Stress Reduction ProgramAlso: MindfulnessParticipants were introduced to each other and provided with information related to pregnancy. The Mindfulness-Based Stress Reduction Program (MBSR) was introduced. The participants shared their levels of well-being, stress, coping mechanisms for fear of childbirth, and their expectations from the MBSR program. Awareness of habitual behaviors was facilitated. Afterwards, breath-focused meditation and dried fruit meditation were practiced. Participants were encouraged to maintain awareness of activities performed at any time during the day. Lastly, body scan meditation was taught, and participants were instructed to repeat the practice throughout the week using audio recordings. | Other | Mindfulness-Based Stress Reduction Program |
Primary outcome
Psychological Well-Being Scale
Time frame: change from starting to 4. and 8. week
The Psychological Well-Being Scale, developed, consists of eight items aimed at measuring psychological well-being levels. The internal consistency coefficient of the scale is 0.87. The Turkish adaptation of the Psychological Well-Being Scale was conducted, who found the internal consistency coefficient to be 0.87 as well. The scale is rated on a 1-7 point scale, with higher scores indicating that the individual possesses psychological strengths.
Perceived Stress Scale
Time frame: change from starting to 4. and 8. week
The Perceived Stress Scale, consisting of 14 items, was developed to measure the degree to which individuals perceive certain situations in their lives as stressful. The scale is assessed using a 5-point Likert-type scoring system, ranging from 0 to 4. It comprises two factors: 'perception of stress/discomfort' and 'perception of inadequacy.' The scale allows for a maximum score of 56 and a minimum score of 0, with scores increasing as stress levels rise. The validity and reliability of the scale were established. The Turkish version of the Perceived Stress Scale (PSS-14) has an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87.
Wijma Delivery Expectancy/Experience Scale (W-DEQ) Version A
Time frame: change from starting to 4. and 8. week
The scale, consists of 33 items. Responses to the items are rated on a scale from 0 to 5, utilizing a six-point Likert-type format. The maximum score attainable on the scale is 165, while the minimum is 0. A higher total score indicates a greater level of fear. Specifically, a scale score of 85 or above reflects clinical levels of birth fear, scores between 66 and 84 indicate severe fear, scores between 38 and 65 denote moderate fear, and scores of 37 and below signify mild levels of birth fear. The Cronbach's alpha coefficient for the scale is found to be 0.88 for first-time mothers (primiparous) and 0.90 for mothers who have given birth before (multiparous).
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 21 Nov 2024.
- Derived from this study: PubMed 42399888Kucukkaya B, Ozturk S, Ekrem EC. Comparison of the effects of haptonomy application and mindfulness-based stress reduction on psychological well-being, perceived stress, and fear of childbirth in primiparous women: a randomized controlled trial. BMC Complement Med Ther. 2026 Jul 3. doi: 10.1186/s12906-026-05452-w. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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 Haptonomy and Mindfulness-Based Stress Reduction Program in people with Mindfulness-Based Stress Reduction, run by Trakya 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 8 inclusion and 8 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 21 Nov 2024. 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?
Psychological Well-Being Scale (time frame: change from starting to 4. and 8. week). The study lists 3 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 NCT06699550, 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 21 Nov 2024.