Maternal Fetal Attachment Pregnancy PerceptionNCT06724874
Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception
A study testing Web-Based Deep Relaxation Exercise in people with Maternal Fetal Attachment Pregnancy Perception and Pregnancy Perception, run by Çankırı Karatekin University.
Trial summary
This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. 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 Pregnancy Perception, Pregnancy Perception
- What is being tested?
- Web-Based Deep Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Jun 2025
- 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
- Women with internet access,
- Women expecting a single baby,
- Women whose pregnancy is 12-24 weeks
Who cannot join
- Women with a history of physical and/or psychological illness and those taking any psychiatric medication
- Women who answered the survey questions incompletely.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception: A Randomized Controlled Trial
This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. The study is planned to be conducted with pregnant women reached through social media (such as Facebook, Messenger, Instagram). The study is planned to be conducted between December 15, 2024 and June 15, 2025. The universe of the study will consist of pregnant women who volunteer to participate in online deep relaxation exercises and share their contact information. When the power analysis was performed, the sample size was calculated as a total of 80 pregnant women (40 experimental, 40 control), assuming that the web-based deep relaxation exercise applied would increase the mean maternal-fetal attachment score (72.25±7.16) (Güney and Uçar, 2019) by four and a half points at a 5% error level, a two-sided significance level, a 95% confidence interval, and an 80% ability to represent the universe (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html). Pregnant women to be included in the groups will be selected from the relevant population using the improbable random sampling method.
- Being tested
- Web-Based Deep Relaxation Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Deep Relaxation ExerciseOther
Web-based deep relaxation exercise videos have been prepared online. Each video lasts approximately 20-25 minutes. The 4-week applications will be sent to pregnant women one video each week and they will be asked to continue the exercises at home 4 times a week.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| Web-based deep relaxation exercise | Experimental | Not described Receives: Other: Web-Based Deep Relaxation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment
Measured: Four months
Secondary outcomes (1)
The effect of online web-based deep relaxation exercise applied to pregnant women on pregnancy perception
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal Fetal Attachment Pregnancy PerceptionStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Gökbulut, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724874
- Sponsor's protocol ID
- KARATEKIN UNIVERSITY
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared, because before starting the research, pregnant women who will participate in the research, as they will be guaranteed that their personal information will be kept completely confidential and will only be used for this research purpose.
Publications
Kumcağız H, Ersanlı E, Murat N. The Development of a Self-perception of Pregnants Scale and its Psychometric Features.Journal of Psychiatric Nursing 2017;8(1):23-31
Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.
PubMed 24962076
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06724874
- Acronym / sponsor ID
- KARATEKIN UNIVERSITY
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 9 Dec 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.
This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. The study is planned to be conducted with pregnant women reached through social media (such as Facebook, Messenger, Instagram). The study is planned to be conducted between December 15, 2024 and June 15, 2025. The universe of the study will consist of pregnant women who volunteer to participate in online deep relaxation exercises and share their contact information. When the power analysis was performed, the sample size was calculated as a total of 80 pregnant women (40 experimental, 40 control), assuming that the web-based deep relaxation exercise applied would increase the mean maternal-fetal attachment score (72.25±7.16) (Güney and Uçar, 2019) by four and a half points at a 5% error level, a two-sided significance level, a 95% confidence interval, and an 80% ability to represent the universe (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html). Pregnant women to be included in the groups will be selected from the relevant population using the improbable random sampling method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| Web-based deep relaxation exercise | Experimental | Other: Web-Based Deep Relaxation Exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with internet access,
- Women expecting a single baby,
- Women whose pregnancy is 12-24 weeks
Key exclusion criteria (2 listed)
- Women with a history of physical and/or psychological illness and those taking any psychiatric medication
- Women who answered the survey questions incompletely.
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 |
|---|---|---|
| Web-Based Deep Relaxation ExerciseWeb-based deep relaxation exercise videos have been prepared online. Each video lasts approximately 20-25 minutes. The 4-week applications will be sent to pregnant women one video each week and they will be asked to continue the exercises at home 4 times a week. | Other | Web-based deep relaxation exercise |
Primary outcome
Effect of online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment
Time frame: Four months
1 secondary outcome
The effect of online web-based deep relaxation exercise applied to pregnant women on pregnancy perception
Time frame: Four months
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 9 Dec 2024.
- BackgroundKumcağız H, Ersanlı E, Murat N. The Development of a Self-perception of Pregnants Scale and its Psychometric Features.Journal of Psychiatric Nursing 2017;8(1):23-31
- Background: PubMed 24962076Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared, because before starting the research, pregnant women who will participate in the research, as they will be guaranteed that their personal information will be kept completely confidential and will only be used for this research purpose.
Related trials for Maternal Fetal Attachment Pregnancy Perception
Not yet recruiting
Prenatal Haptonomy-Based Support for Attachment and Partner Support
Maternal-Fetal Attachment, Perceived Partner Support
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.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Deep Relaxation Exercise in people with Maternal Fetal Attachment Pregnancy Perception and Pregnancy Perception, run by Çankırı Karatekin University.
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 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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 Nilay Gökbulut (903762189500, ngokbulut@karatekin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment (time frame: Four months). 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 NCT06724874, which also lists 2 linked publications.
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 9 Dec 2024.