NCT07159984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

18 days

First QC Date

August 30, 2025

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    change from Baseline (before implementation) and at 1st and 4th weeks of practice

Study Arms (2)

Education group

EXPERIMENTAL
Behavioral: Education on Changes During Pregnancy

Control group

NO INTERVENTION

Interventions

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.

Education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those who withdrew or dropped out of the study early,
  • Those who were not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

May 18, 2025

Primary Completion

June 5, 2025

Study Completion

August 30, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations