Effects of Virtual Reality Application and Progressive Relaxation Exercise

NCT ID: NCT06896955

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Exercise Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

PMR Education

Intervention Type OTHER

PMR education

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.

Group Type EXPERIMENTAL

PMR+VR Education

Intervention Type OTHER

PMR and VR education

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PMR+VR Education

PMR and VR education

Intervention Type OTHER

PMR Education

PMR education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Sule Gokyildiz Surucu

Sule Gokyildiz Surucu

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Senay Dagilgan, Msc

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Sule Gokyildiz Surucu, Prof.

Role: CONTACT

+90 (322) 338 64 84 ext. 1161

Senay Dagilgan, Msc

Role: CONTACT

+90 (322) 338 65 38 ext. 136

Facility Contacts

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Senay Dagilgan, Msc

Role: primary

+093223386538 ext. 136

Sule Gokyildiz Surucu, Prof.

Role: backup

+093223386484 ext. 1161

Other Identifiers

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01.09.2023/55

Identifier Type: -

Identifier Source: org_study_id

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