- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663812
THE EFFECT OF MOTIVATIONAL INTERVENTIONS LED PREGNANCY ON STRESS AND ALEXITHYMIA IN COUPLES (ALEXITHYMIA)
June 23, 2026 updated by: ESMA KIR, Tokat Gaziosmanpasa University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ESMA KIR
- Phone Number: +905550617545
- Email: esma.kir@bozok.edu.tr
Study Locations
-
-
Center
-
Yozgat, Center, Turkey (Türkiye)
- Recruiting
- Yozgat City Hospital
-
Contact:
- ESMA KIR
- Phone Number: 05550617545
- Email: esma.kir@bozok.edu.tr.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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),
- 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,
Exclusion Criteria:
• 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No motivational interview
the group of pregnant women and their partners who did not receive motivational counseling
|
|
|
Experimental: There is a motivational interview
a group where motivational sessions are held for pregnant women and their partners
|
a group where motivational sessions are held for pregnant women and their partners
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2. Toronto Alexithymia Scale (TAS):
Time Frame: 24 weeks
|
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.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
June 13, 2026
First Submitted That Met QC Criteria
June 17, 2026
First Posted (Actual)
June 23, 2026
Study Record Updates
Last Update Posted (Actual)
June 26, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 30.10.2025 - 646244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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