Pregnant WomenNCT07159984
Training Given to Pregnant Women and Their Partners on Coping With Stress as a Couple, Couple Adjustment, Complaints and Quality of Life
A study testing Education on Changes During Pregnancy in people with Pregnant Women and Coping With Stress as a Couple, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to examine the effect of education provided to pregnant women and their partners on coping with stress as a couple, couple harmony, complaints, and quality of life regarding changes during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Coping With Stress as a Couple, Dyadic Adjustment
- What is being tested?
- Education on Changes During Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2025to 30 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women and their spouses who are over 18 years of age,
- Literate and able to understand Turkish,
- Married,
- With a living spouse,
- Primiparous,
- Who have applied to the Bartın Provincial Health Directorate Healthy Life Center Pregnancy Class,
- Have written consent, and volunteer to participate in the study
Who cannot join
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training Given to Pregnant Women and Their Partners on Coping With Stress as a Couple, Couple Adjustment, Complaints and Quality of Life: A Randomized Controlled Study
Objective: This study aims to examine the effect of education provided to pregnant women and their partners on coping with stress as a couple, couple harmony, complaints, and quality of life regarding changes during pregnancy.
- Conditions
- Pregnant Women, Coping With Stress as a Couple, Dyadic Adjustment, Complaints, Quality of Life, Education
- Being tested
- Education on Changes During Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on Changes During PregnancyBehavioural
In the first session of the researcher-prepared training presentation, women will be informed about the structure and functions of their internal and external reproductive organs, as well as changes in physical, hormonal, social, and lifestyle activities. After the first session, there will be a 15-minute break before the second session, which will include evidence-based training on the effects of pregnancy-related changes on stress, couple harmony, and quality of life. Methods for coping with stress and pregnancy-related complaints, process management that positively impacts couple harmony, and healthy lifestyle behaviors that enhance quality of life will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Not described Receives: Behavioral: Education on Changes During Pregnancy |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Couple Coping Inventory
Developed by Bodenmann to measure couple coping and stress communication in romantic relationships . The inventory is a 5-point Likert-type scale with 37 items. Item scores range from 1 (never) to 5 (always).
Measured: change from Baseline (before implementation) and at 1st and 4th weeks of practice
The Pregnancy Complaints and Their Impact on Quality of Life Scale
This scale measures pregnancy complaints and their impact on quality of life. The scale contains 42 items and consists of two sections. The first section assesses the frequency of pregnancy-related complaints experienced in the past month, and the second section assesses how these complaints impact daily activities. As the total score increases, quality of life decreases.
Measured: change from Baseline (before implementation) and at 1st and 4th weeks of practice
The Revised Dyadic Adjustment Scale
The RDS is the final version of the 32-item Dyadic Adjustment Scale developed by Spanier, which was revised and reduced to 14 items.
Measured: change from Baseline (before implementation) and at 1st and 4th weeks of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start18 May 2025
- Primary completion5 Jun 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- 68 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
- NCT07159984
- Sponsor's protocol ID
- 2025-SBB-0331
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given to Pregnant Women and Their Partners on Coping With Stress as a Couple, Couple Adjustment, Complaints and Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07159984
- Acronym / sponsor ID
- 2025-SBB-0331
- Conditions
- Pregnant Women, Coping With Stress as a Couple, Dyadic Adjustment, Complaints, Quality of Life, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 18 May 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 8 Sep 2025 (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.
Objective: This study aims to examine the effect of education provided to pregnant women and their partners on coping with stress as a couple, couple harmony, complaints, and quality of life regarding changes during pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: Education on Changes During Pregnancy |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women and their spouses who are over 18 years of age,
- Literate and able to understand Turkish,
- Married,
- With a living spouse,
- Primiparous,
Key exclusion criteria (2 listed)
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in 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 |
|---|---|---|
| Education on Changes During PregnancyIn the first session of the researcher-prepared training presentation, women will be informed about the structure and functions of their internal and external reproductive organs, as well as changes in physical, hormonal, social, and lifestyle activities. After the first session, there will be a 15-minute break before the second session, which will include evidence-based training on the effects of pregnancy-related changes on stress, couple harmony, and quality of life. Methods for coping with stress and pregnancy-related complaints, process management that positively impacts couple harmony, and healthy lifestyle behaviors that enhance quality of life will be discussed. | Behavioural | Education group |
Primary outcome
The Couple Coping Inventory
Time frame: change from Baseline (before implementation) and at 1st and 4th weeks of practice
Developed by Bodenmann to measure couple coping and stress communication in romantic relationships . The inventory is a 5-point Likert-type scale with 37 items. Item scores range from 1 (never) to 5 (always).
The Pregnancy Complaints and Their Impact on Quality of Life Scale
Time frame: change from Baseline (before implementation) and at 1st and 4th weeks of practice
This scale measures pregnancy complaints and their impact on quality of life. The scale contains 42 items and consists of two sections. The first section assesses the frequency of pregnancy-related complaints experienced in the past month, and the second section assesses how these complaints impact daily activities. As the total score increases, quality of life decreases.
The Revised Dyadic Adjustment Scale
Time frame: change from Baseline (before implementation) and at 1st and 4th weeks of practice
The RDS is the final version of the 32-item Dyadic Adjustment Scale developed by Spanier, which was revised and reduced to 14 items.
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 8 Sep 2025.
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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 Education on Changes During Pregnancy in people with Pregnant Women and Coping With Stress as a Couple, 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 7 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 8 Sep 2025. 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 Couple Coping Inventory (time frame: change from Baseline (before implementation) and at 1st and 4th weeks of practice). 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 8 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.