Effects of Virtual Reality Application and Progressive Relaxation Exercise
1 other identifier
interventional
75
1 country
1
Brief Summary
In the study, random assignment and randomization concealment will be applied to control selection bias. Pregnant women were assigned to groups by an independent statistician using the block randomization method. For this purpose, 6-digit combinations consisting of the letters "A", "B" and "C" were first created in the randomization of 78 women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Mar 2025
Shorter than P25 for not_applicable pregnancy
1 active site
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
First Submitted
Initial submission to the registry
March 20, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedMarch 26, 2025
March 1, 2025
5 months
March 20, 2025
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pregnancy Stress Assessment Scale
Change in pregnancy-related stress levels in pregnant women. As the score from the scale increases, stress increases.
pre-intervention, after 2 month
Birth Self-Efficacy Scale
Change in self-efficacy levels of pregnant women during labor. As the score from the scale increases, self-efficacy increases.
intervention after 2 month
Birth Affect Scale
Change in the emotional state experienced by mothers during labor. As the score from the scale increases, positive affect increases.
intervention after 2 month
Study Arms (3)
PMR Group
EXPERIMENTAL* After meeting the pregnant woman in the polyclinic, a personal information form and the Pregnancy Stress Assessment Scale will be filled out at the beginning of the research. * PMR will be explained to the pregnant woman and the first application will be done together. Any questions the pregnant woman may have will be answered. * An education booklet will be given about PMR. * The application will be performed 3 times a week starting at the 32nd week of pregnancy until labor begins, each application lasting 20 minutes. * The first application will be done face to face, and subsequent applications will be done by the pregnant woman herself, accompanied by a PMRvideo. * Continuous communication will be maintained with the pregnant woman via mobile phone. * The Pregnancy Stress Assessment Scale will be filled out at the 38th week. * The Birth Affect Scale and Birth Self-Efficacy Scale will be filled out on the first day after birth.
VR+PMR Group
EXPERIMENTAL* PMR will be applied to this group accompanied by a therapeutic video shown with virtual reality glasses. * At the beginning of the research, a personal information form and the Pregnancy Stress Assessment Scale will be filled out. * An educational booklet about PMR will be given. * After both application methods are shown and applied, PGE will be applied together accompanied by a therapeutic video shown with virtual reality glasses. * The application will be performed 3 times a week starting from the 32nd week of pregnancy until labor begins, 20 minutes each time. * The first application will be done face to face, and subsequent applications will be done by the pregnant woman herself. * Pregnancy Stress Assessment Scale will be filled out again in the 38th week. * On the first day after delivery, the Birth Affect Scale, Birth Self-Efficacy Scale and Virtual Reality Glasses Application Evaluation Form will be filled out.
Control Group
NO INTERVENTION* Pregnant women in the control group will not be subjected to any treatment other than routine pregnancy follow-up and examinations at the hospital. * Forms will be filled out in parallel with the intervention groups. * Participants who wish will be given an educational booklet about PGE at the end of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Voluntary participation
- No communication difficulties (no mental retardation, no visual/hearing impairment)
- Knowing Turkish and being literate
- No fetal anomalies
- Being in the 32nd week of pregnancy
- Not being diagnosed with a risky pregnancy (multiple pregnancy, premature rupture of membranes, preeclampsia, gestational diabetes, placenta previa, etc., pregnancies may end with a cesarean section)
You may not qualify if:
- Having a psychiatric disease diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, 01330, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Senay Dagilgan, Msc
Cukurova University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sule Gokyildiz Surucu
Study Record Dates
First Submitted
March 20, 2025
First Posted
March 26, 2025
Study Start
March 25, 2025
Primary Completion
August 25, 2025
Study Completion
March 25, 2026
Last Updated
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share