Birth Outcome, AdverseNCT06508554
The Door to the Womb at Birth: Haptonomy
A study testing Haptonomy in people with Birth Outcome, Adverse and Self Efficacy, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor. 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
- Birth Outcome, Adverse, Self Efficacy, Memory Impairment
- What is being tested?
- Haptonomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 1 Aug 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
- Married and pregnant women,
- ≥ 18 years old,
- Able to read, write and understand Turkish,
- Living in the city center where the study is conducted,
- Does not have any physical or psychological health problems for herself or her baby,
- Having a spontaneous pregnancy at 28.< gestational weeks,
- Those who have not received haptonomy application before,
- Pregnant women who agreed to participate in the study were included.
Who cannot join
- Those with psychological and chronic health problems,
- Pregnant women who did not agree to participate in the study were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor.
Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.
- Being tested
- Haptonomy
- Keywords
- Haptonomy, Birth Expectation
- Medical subject headings
- Pregnancy Complications, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaptonomyOther
- With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. It will be ensured that the mother's communication with her baby has a spiritual dimension as well as a physical one. 6. Then the stage of touching and communicating with the baby will begin. The hands of the researcher and the pregnant woman will be placed on the pregnant woman's uterus. Then, the pregnant woman will be the first to call her baby. This call to the baby will be repeated 2-3 times. 7. The pregnant woman and her uterus will be touched and exercises will be performed to adapt to the fetus. The aim is to increase the emotional awareness of the pregnant woman and to enable her to play intrauterine games with her baby (such as calling the baby, shaking her belly, moving the baby to the touched area with the mother's voice). Haptonomy will be completed with a deep relaxation exercise that will support the heart-uterus connection accompanied by breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No action will be taken. Surveys and scales will be applied. |
| Haptonomy | Experimental | 1. A face-to-face sitting position will be taken for the application.
2. Throughout the research, the study will be accompanied by the music desired by each pregnant woman. The same music chosen by the woman or couple will be used throughout the work.
3. The application will be done with the pregnant woman's eyes closed.
4. The application will start with breathing exercises and the body will be relaxed with the help of abdominal and chest breathing (hara breathing).
5. With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. The researcher and the pregnant woman will place their left hands on each other's hearts. The aim is to feel the energy flowing from each other, to feel the heart, to open the third eye and to prepare the hands. This study aims to increase the pregnant woman's confidence in her own emotions and body by getting to know her emotions and body. Receives: Other: Haptonomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version
This scale was adapted from Wijma et al. Developed by. The purpose of the scale is to evaluate women's fear of birth during their own birth experiences in the postpartum period. Turkish validity and reliability study was conducted by Uçar and Beji. The scale consists of 33 items. Each item is a 6-point Likert type with scores ranging from 1 to 6, with 1 being "completely" and 6 being "not at all". While the minimum score on the scale is 33, the maximum score is 198. High scores indicate that women have a high fear of childbirth. Negatively loaded questions in the scale (2, 3, 6, 7, 8, 11, 12,15, 19, 20, 24, 25, 27, 31) are calculated by reversing them in the opposite direction to ensure consistency in measurement.
Measured: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
Self-Efficacy Scale in Labor
Self-Efficacy Scale in Labor - Short Version' was developed by Ip et al. to measure self-efficacy levels in labor. The Turkish validity and reliability study of the scale was conducted by Ersoy (2011). The scale consists of two sub-dimensions: outcome expectation and competence expectation, and there are 16 questions in each sub-dimension. The lowest score to be obtained from the sub-dimensions of the scale is 16 and the highest score is 160. A high score from each subscale indicates that pregnant women have high expectations of adequacy and outcome regarding labor. Responses on a Likert-type scale are scored from 1 to 10.
Measured: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
Birth Memory and Recall Scale
This scale developed by Foley et al. in 2014, was adapted into Turkish by Topkara and Çağan in 2021. The scale is a 7-point Likert type. The scale, which consists of a total of 21 items, has six sub-dimensions. Its sub-dimensions are "Emotional Memory", "Ambivalent Emotional Memory", "Centeredness of Memory", "Coherence and Reliving", "Sensory Memory" and "Involuntary Remembering". The highest score that can be obtained from the scale is 147 and the lowest score is 6. High scores from the "Emotional Memory" sub-dimension indicate that the mother's negative emotions about the birth experience are more intense, high scores from the "Ambivalent Emotional Memory" sub-dimension indicate that the mother has more ambivalent emotions, and high scores from the "Centeredness of Memory" sub-dimension indicate that the mother has more ambivalent emotions.
Measured: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Oct 2023
- Primary completion25 Feb 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Outcome, AdverseStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508554
- Sponsor's protocol ID
- 2023-SBB-0594
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Door to the Womb at Birth: Haptonomy
- ClinicalTrials.gov ID
- NCT06508554
- Acronym / sponsor ID
- 2023-SBB-0594
- Keywords
- Haptonomy, Birth Expectation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Jul 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.
Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor.
Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No action will be taken. Surveys and scales will be applied. |
| Haptonomy | Experimental | Other: Haptonomy1. A face-to-face sitting position will be taken for the application. 2. Throughout the research, the study will be accompanied by the music desired by each pregnant woman. The same music chosen by the woman or couple will be used throughout the work. 3. The application will be done with the pregnant woman's eyes closed. 4. The application will start with breathing exercises and the body will be relaxed with the help of abdominal and chest breathing (hara breathing). 5. With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. The researcher and the pregnant woman will place their left hands on each other's hearts. The aim is to feel the energy flowing from each other, to feel the heart, to open the third eye and to prepare the hands. This study aims to increase the pregnant woman's confidence in her own emotions and body by getting to know her emotions and body. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Married and pregnant women,
- ≥ 18 years old,
- Able to read, write and understand Turkish,
- Living in the city center where the study is conducted,
- Does not have any physical or psychological health problems for herself or her baby,
Key exclusion criteria (2 listed)
- Those with psychological and chronic health problems,
- Pregnant women who did not agree to participate in the study were not included.
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 |
|---|---|---|
| Haptonomy5. With the energy work, we will move on to the stage of harmonizing the intuitive and heart energy fields. It will be ensured that the mother's communication with her baby has a spiritual dimension as well as a physical one. 6. Then the stage of touching and communicating with the baby will begin. The hands of the researcher and the pregnant woman will be placed on the pregnant woman's uterus. Then, the pregnant woman will be the first to call her baby. This call to the baby will be repeated 2-3 times. 7. The pregnant woman and her uterus will be touched and exercises will be performed to adapt to the fetus. The aim is to increase the emotional awareness of the pregnant woman and to enable her to play intrauterine games with her baby (such as calling the baby, shaking her belly, moving the baby to the touched area with the mother's voice). Haptonomy will be completed with a deep relaxation exercise that will support the heart-uterus connection accompanied by breathing exercises. | Other | Haptonomy |
Primary outcome
Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version
Time frame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
This scale was adapted from Wijma et al. Developed by. The purpose of the scale is to evaluate women's fear of birth during their own birth experiences in the postpartum period. Turkish validity and reliability study was conducted by Uçar and Beji. The scale consists of 33 items. Each item is a 6-point Likert type with scores ranging from 1 to 6, with 1 being "completely" and 6 being "not at all". While the minimum score on the scale is 33, the maximum score is 198. High scores indicate that women have a high fear of childbirth. Negatively loaded questions in the scale (2, 3, 6, 7, 8, 11, 12,15, 19, 20, 24, 25, 27, 31) are calculated by reversing them in the opposite direction to ensure consistency in measurement.
Self-Efficacy Scale in Labor
Time frame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
Self-Efficacy Scale in Labor - Short Version' was developed by Ip et al. to measure self-efficacy levels in labor. The Turkish validity and reliability study of the scale was conducted by Ersoy (2011). The scale consists of two sub-dimensions: outcome expectation and competence expectation, and there are 16 questions in each sub-dimension. The lowest score to be obtained from the sub-dimensions of the scale is 16 and the highest score is 160. A high score from each subscale indicates that pregnant women have high expectations of adequacy and outcome regarding labor. Responses on a Likert-type scale are scored from 1 to 10.
Birth Memory and Recall Scale
Time frame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
This scale developed by Foley et al. in 2014, was adapted into Turkish by Topkara and Çağan in 2021. The scale is a 7-point Likert type. The scale, which consists of a total of 21 items, has six sub-dimensions. Its sub-dimensions are "Emotional Memory", "Ambivalent Emotional Memory", "Centeredness of Memory", "Coherence and Reliving", "Sensory Memory" and "Involuntary Remembering". The highest score that can be obtained from the scale is 147 and the lowest score is 6. High scores from the "Emotional Memory" sub-dimension indicate that the mother's negative emotions about the birth experience are more intense, high scores from the "Ambivalent Emotional Memory" sub-dimension indicate that the mother has more ambivalent emotions, and high scores from the "Centeredness of Memory" sub-dimension indicate that the mother has more ambivalent emotions.
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 27 Aug 2024.
- 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 in people with Birth Outcome, Adverse and Self Efficacy, 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 2 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 27 Aug 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?
Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version (time frame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.). 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?
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 27 Aug 2024.