Effects of Virtual Reality Application and Progressive Relaxation Exercise

March 20, 2025 updated by: Sule Gokyildiz Surucu, Cukurova University

Effects of Virtual Reality Application and Progressive Relaxation Exercise Training on Pregnant Women's Stress, Birth Affect and Birth Self-Efficacy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There will be three groups in the randomized experimental controlled study:PRE (Progressive Relaxation Exercise), VR (Virtual Reality)+PGR (Progressive Relaxation Exercise) and Control group. In order to carry out the application phase of the study, the responsible researcher participated in the training program on PRE and received a certificate on this subject. In addition, permission for the use of PRE Cd was obtained from the Turkish Psychologists Association to be used in the PRE group. The following procedures will be performed for pregnant women included in the study.

Study Type

Interventional

Enrollment (Estimated)

75

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

Study Contact Backup

Study Locations

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:

  • 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)

Exclusion Criteria:

  • Having a psychiatric disease diagnosis

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PMR Group
  • 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.
Other: PMR Education
PMR education
Experimental: VR+PMR Group
  • 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.
Other: PMR+VR Education
PMR and VR education
No Intervention: Control Group
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Stress Assessment Scale
Time Frame: pre-intervention, after 2 month
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
Time Frame: intervention after 2 month
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
Time Frame: intervention after 2 month
Change in the emotional state experienced by mothers during labor. As the score from the scale increases, positive affect increases.
intervention after 2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Senay Dagilgan, Msc, Cukurova University

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 (Estimated)

March 25, 2025

Primary Completion (Estimated)

August 25, 2025

Study Completion (Estimated)

March 25, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01.09.2023/55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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