Father-Child RelationsHaptonomyNCT05329948
Application of Haptonomy and Pregnancy Adjustment, Paternal Attachment
A study testing Haptonomy application in people with Father-Child Relations, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Father-Child Relations
- What is being tested?
- Haptonomy application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2022to 5 Apr 2023
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least primary school graduate,
- Being at the 24th and 32nd week of pregnancy
- Living with your partner
Who cannot join
- Having problems with his wife
- Living apart with his wife
- Pregnant women who have completed the 32nd gestational week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Haptonomy Application on Pregnancy Adjustment and Prenatal Attachment of Fathers
The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy.
Therefore, this study; It was aimed to evaluate the effect of haptonomy application on prenatal attachment of fathers and compliance with pregnancy and to contribute to the midwifery literature of the results.
Read the detailed description
In accordance with the literature review, no similar study was found in our country. The reason for the application of haptonomy in pregnancy is the sense of touch, which develops in the first 2 months of pregnancy and is an emotional sense. The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy. Therefore, this study; The aim of this study was to evaluate the effect of haptonomy application on prenatal attachment of fathers and adaptation of pregnant women to pregnancy.
- Conditions
- Father-Child Relations
- Being tested
- Haptonomy application
- Keywords
- fetus, midwifery, pregnancy, haptonomy, father
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haptonomy applicationOther
Feeling the fetus by touching the mother's womb with meditation
| Study group | Role | What they receive |
|---|---|---|
| haptonomy application | Experimental | The data will be obtained by applying a pre-test to the pregnant women and their spouses included in the experimental group before the application. After the pre-test data are collected, 5 sessions of haptonomy will be applied to the couples in the experimental group. Each session (Breath awareness and diaphragm breathing 5 minutes, Feminine energy attunement and heart-looking energy work 5 minutes, Physical communication with the baby in the womb with touches 10 minutes, meditation from the heart to the uterus 15 minutes, awareness of the environment, closing breath and feedback 5 minutes) It will be 40 minutes. For the effectiveness and continuity between each session, planning will be made for 3 days to 7 days. The final test will be applied 1 week after the hapatonomy application (after 5 sessions are completed). Receives: Other: Haptonomy application |
| Control | No intervention | no application will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Haptonomy Application Prenatal Attachment of Fathers
The research is an experimentally planned randomized controlled trial. The sample of the study consists of pregnant women and their spouses (70 experimental group, 70 control group) between the 24th and 32nd weeks.
Fetal attachment of prospective fathers was evaluated with the intrauterine father attachment scale. Intrauterine Father Attachment consists of 23 items. A minimum score of 23 and a maximum of 92 points is obtained on the scale. Scale has no cutoff point. High scores obtained indicate high level of attachment of father to fetus before birth; low scores mean that the father's level of prenatal attachment to the fetus is low.
Measured: one month
Secondary outcomes (1)
The Effect of Haptonomy Application on Pregnancy Adjustment
Pregnancy compliance of pregnant women was evaluated with the prenatal self-rating scale. The scale is a 4-point Likert-type scale with 79 items and 7 sub-dimensions. A minimum of 79 and a maximum of 316 points can be obtained for the entire scale. Scale has no cutoff point. Low scores indicate high compliance with pregnancy.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start5 Apr 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Father-Child RelationsStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel ÖZTÜRK, Ataturk University
- Investigators
- Sibel ÖZTÜRK, Asst.Prof., Study director, Atatürk University Faculty of Health Sciences Department of Midwifery Yakutiye/ErzurumNazlı AKAR, Phd, Principal investigator, Kafkas University Faculty of Health Sciences Department of Midwifery Merkez/Kars
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329948
- Sponsor's protocol ID
- Ataturk University SÖZTÜRK0001
- Acronym
- Haptonomy
- Status last verified
- Jul 2023
- First submitted
- 3 Jan 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The principle of "Informed Consent" by informing the pregnant women and their spouses who meet the research criteria and want to support the research, the principle of "Respect for Autonomy" by stating that they are free to participate in the research, the principle of "Confidentiality and Protection of Confidentiality" by stating that the information of the pregnant women and spouses participating in the research will be kept confidential. will be fulfilled.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Haptonomy Application on Pregnancy Adjustment and Prenatal Attachment of Fathers
- ClinicalTrials.gov ID
- NCT05329948
- Acronym / sponsor ID
- Haptonomy / Ataturk University SÖZTÜRK0001
- Conditions
- Father-Child Relations
- Keywords
- fetus, midwifery, pregnancy, haptonomy, father
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 15 Apr 2022 (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.
The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy.
Therefore, this study; It was aimed to evaluate the effect of haptonomy application on prenatal attachment of fathers and compliance with pregnancy and to contribute to the midwifery literature of the results.
Detailed description
In accordance with the literature review, no similar study was found in our country. The reason for the application of haptonomy in pregnancy is the sense of touch, which develops in the first 2 months of pregnancy and is an emotional sense. The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy. Therefore, this study; The aim of this study was to evaluate the effect of haptonomy application on prenatal attachment of fathers and adaptation of pregnant women to pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| haptonomy application | Experimental | Other: Haptonomy applicationThe data will be obtained by applying a pre-test to the pregnant women and their spouses included in the experimental group before the application. After the pre-test data are collected, 5 sessions of haptonomy will be applied to the couples in the experimental group. Each session (Breath awareness and diaphragm breathing 5 minutes, Feminine energy attunement and heart-looking energy work 5 minutes, Physical communication with the baby in the womb with touches 10 minutes, meditation from the heart to the uterus 15 minutes, awareness of the environment, closing breath and feedback 5 minutes) It will be 40 minutes. For the effectiveness and continuity between each session, planning will be made for 3 days to 7 days. The final test will be applied 1 week after the hapatonomy application (after 5 sessions are completed). |
| Control | No intervention | –no application will be made |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- At least primary school graduate,
- Being at the 24th and 32nd week of pregnancy
- Living with your partner
Key exclusion criteria (3 listed)
- Having problems with his wife
- Living apart with his wife
- Pregnant women who have completed the 32nd gestational week
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 |
|---|---|---|
| Haptonomy applicationFeeling the fetus by touching the mother's womb with meditation | Other | haptonomy application |
Primary outcome
The Effect of Haptonomy Application Prenatal Attachment of Fathers
Time frame: one month
The research is an experimentally planned randomized controlled trial. The sample of the study consists of pregnant women and their spouses (70 experimental group, 70 control group) between the 24th and 32nd weeks. Fetal attachment of prospective fathers was evaluated with the intrauterine father attachment scale. Intrauterine Father Attachment consists of 23 items. A minimum score of 23 and a maximum of 92 points is obtained on the scale. Scale has no cutoff point. High scores obtained indicate high level of attachment of father to fetus before birth; low scores mean that the father's level of prenatal attachment to the fetus is low.
1 secondary outcome
The Effect of Haptonomy Application on Pregnancy Adjustment
Time frame: one month
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 Jul 2023.
- Individual participant dataSharing planned: No. The principle of "Informed Consent" by informing the pregnant women and their spouses who meet the research criteria and want to support the research, the principle of "Respect for Autonomy" by stating that they are free to participate in the research, the principle of "Confidentiality and Protection of Confidentiality" by stating that the information of the pregnant women and spouses participating in the research will be kept confidential. will be fulfilled.
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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.
Sibel ÖZTÜRK, Asst.Prof. study director
Atatürk University Faculty of Health Sciences Department of Midwifery Yakutiye/Erzurum
Nazlı AKAR, Phd principal investigator
Kafkas University Faculty of Health Sciences Department of Midwifery Merkez/Kars
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 application in people with Father-Child Relations, run by Ataturk 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 3 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 Jul 2023. 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?
The Effect of Haptonomy Application Prenatal Attachment of Fathers (time frame: one month). 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 Jul 2023.