Stress Levels During PregnancyALEXITHYMIANCT07663812
THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES
A study testing a group where motivational sessions are held for pregnant women and their partners in people with Stress Levels During Pregnancy and Levels of Alexithymia During Pregnancy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of midwife-led motivational interviewing during pregnancy on couples' stress and alexithymia levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Levels During Pregnancy, Levels of Alexithymia During Pregnancy
- What is being tested?
- a group where motivational sessions are held for pregnant women and their partners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2026to 30 Oct 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For pregnant women:
- Agreement to participate in the study
- Being 18 years of age or older and married
- Being in the second trimester
- No pregnancy-related risks (such as preeclampsia, diabetes, heart disease, placenta previa, or oligohydramnios),
- No issues related to fetal health (such as fetal anomalies or intrauterine growth restriction),
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- Ability to speak Turkish,
- No history of chronic or psychiatric conditions,
- For partners:
- Agreeing to participate in the study,
- Accompanying their partner during the second trimester of pregnancy,
- Not having a diagnosed psychiatric condition (depression, anxiety disorder, bipolar disorder, etc.),
- Being able to speak and understand Turkish,
Who cannot join
- • Participants deciding to withdraw from the study at any stage,
- Inability to contact the pregnant woman and/or her partner before the data collection process is completed,
- The pregnant woman being diagnosed with a high-risk pregnancy during the data collection process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yozgat City Hospital
Yozgat, Center
ESMA KIR, 05550617545, esma.kir@bozok.edu.tr.edu
About this study
Official title: THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED BY MIDWIVES DURING PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES
The aim of this study is to examine the effect of midwife-led motivational interviewing during pregnancy on couples' stress and alexithymia levels.
Read the detailed description
This study aims to evaluate the effect of midwife-led motivational interviewing during pregnancy on couples' stress coping skills and levels of alexithymia. Designed as a randomized controlled trial, the study includes healthy pregnant women in their second trimester and their partners. The intervention group receives midwife-led motivational interviewing, while the control group receives routine care. Data are collected using the Demographic Information Form, the Coping Styles Scale, and the Toronto Alexithymia Scale. The study results will determine whether midwife-led motivational interviews are an effective intervention for supporting psychological well-being during pregnancy through a couple-centered approach.
- Being tested
- a group where motivational sessions are held for pregnant women and their partners
- Keywords
- Levels of Alexithymia,, Levels of Stress,, Motivational Interviewing, Pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a group where motivational sessions are held for pregnant women and their partnersOther
a group where motivational sessions are held for pregnant women and their partners
| Study group | Role | What they receive |
|---|---|---|
| No motivational interview | No intervention | the group of pregnant women and their partners who did not receive motivational counseling |
| There is a motivational interview | Experimental | a group where motivational sessions are held for pregnant women and their partners Receives: Other: a group where motivational sessions are held for pregnant women and their partners |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Stress Coping Styles Scale (SCSS):
Couples' stress coping skills are being assessed. The assessment is administered twice: as a pre-test (at the beginning) and a post-test (after the intervention). Both the total scale score and the subscale scores are used.
Measured: 24 weeks
1. Stress Coping Styles Scale (SCSS): This scale assesses couples' stress coping skills. It is administered twice: at the pre-test (baseline) and post-test (post-intervention). Both the total scale score and the subscale scores are used.
Measured: 24 weeks
Secondary outcomes (1)
2. Toronto Alexithymia Scale (TAS):
Couples' levels of alexithymia are being assessed. The assessment is administered twice: as a pre-test (at the beginning) and a post-test (after the intervention). Both the total scale score and the subscale scores are used.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start28 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Levels During PregnancyStudies 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
- Model description
- There are two parallel groups (experimental and control). The experimental group receives four sessions of motivational interviewing led by a midwife, while the control group receives routine prenatal education. Both groups undergo assessments before the intervention (pre-test) and after the intervention (post-test).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESMA KIR, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663812
- Sponsor's protocol ID
- 30.10.2025 - 646244
- Acronym
- ALEXITHYMIA
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of participants' personal data and comply with the requirements of the ethics committee's approval, individual patient data will not be shared. The study involves a sensitive population-pregnant women and their partners-and the data collected will be used solely for the purposes of this research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED BY MIDWIVES DURING PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES
- ClinicalTrials.gov ID
- NCT07663812
- Acronym / sponsor ID
- ALEXITHYMIA / 30.10.2025 - 646244
- Keywords
- Levels of Alexithymia,, Levels of Stress,, Motivational Interviewing, Pregnant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 23 Jun 2026 (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 aim of this study is to examine the effect of midwife-led motivational interviewing during pregnancy on couples' stress and alexithymia levels.
Detailed description
This study aims to evaluate the effect of midwife-led motivational interviewing during pregnancy on couples' stress coping skills and levels of alexithymia. Designed as a randomized controlled trial, the study includes healthy pregnant women in their second trimester and their partners. The intervention group receives midwife-led motivational interviewing, while the control group receives routine care. Data are collected using the Demographic Information Form, the Coping Styles Scale, and the Toronto Alexithymia Scale. The study results will determine whether midwife-led motivational interviews are an effective intervention for supporting psychological well-being during pregnancy through a couple-centered approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two parallel groups (experimental and control). The experimental group receives four sessions of motivational interviewing led by a midwife, while the control group receives routine prenatal education. Both groups undergo assessments before the intervention (pre-test) and after the intervention (post-test).
| Arm | Type | Receives |
|---|---|---|
| No motivational interview | No intervention | –the group of pregnant women and their partners who did not receive motivational counseling |
| There is a motivational interview | Experimental | Other: a group where motivational sessions are held for pregnant women and their partnersa group where motivational sessions are held for pregnant women and their partners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For pregnant women:
- Agreeing to participate in the study,
- Accompanying their partner during the second trimester of pregnancy,
- Not having a diagnosed psychiatric condition (depression, anxiety disorder, bipolar disorder, etc.),
- Being able to speak and understand Turkish,
Key exclusion criteria (3 listed)
- • Participants deciding to withdraw from the study at any stage,
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 |
|---|---|---|
| a group where motivational sessions are held for pregnant women and their partnersa group where motivational sessions are held for pregnant women and their partners | Other | There is a motivational interview |
Primary outcome
1. Stress Coping Styles Scale (SCSS):
Time frame: 24 weeks
Couples' stress coping skills are being assessed. The assessment is administered twice: as a pre-test (at the beginning) and a post-test (after the intervention). Both the total scale score and the subscale scores are used.
1. Stress Coping Styles Scale (SCSS): This scale assesses couples' stress coping skills. It is administered twice: at the pre-test (baseline) and post-test (post-intervention). Both the total scale score and the subscale scores are used.
Time frame: 24 weeks
1 secondary outcome
2. Toronto Alexithymia Scale (TAS):
Time frame: 24 weeks
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 26 Jun 2026.
- Individual participant dataSharing planned: No. To protect the privacy of participants' personal data and comply with the requirements of the ethics committee's approval, individual patient data will not be shared. The study involves a sensitive population-pregnant women and their partners-and the data collected will be used solely for the purposes of this research.
Related trials for Stress Levels During Pregnancy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a group where motivational sessions are held for pregnant women and their partners in people with Stress Levels During Pregnancy and Levels of Alexithymia During Pregnancy, run by Tokat Gaziosmanpasa 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 13 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. 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?
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 ESMA KIR (+905550617545, esma.kir@bozok.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Stress Coping Styles Scale (SCSS): (time frame: 24 weeks). The study lists 2 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 26 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.