PregnancyNCT06896955
Effects of Virtual Reality Application and Progressive Relaxation Exercise
A study testing PMR+VR Education and PMR Education in people with Pregnancy and Exercise, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Exercise, Virtual Reality
- What is being tested?
- PMR+VR Education and PMR Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Having a psychiatric disease diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Cukurova University
Adana, 01330
Senay Dagilgan, Msc, +093223386538 ext. 136, sdagilgan@cu.edu.tr
Sule Gokyildiz Surucu, Prof., +093223386484 ext. 1161, gokyildizsurucu@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Exercise, Virtual Reality
- Being tested
- PMR+VR Education, PMR Education
- Keywords
- Pregnancy, Exercise, progressive exercise, virtual reality
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMR+VR EducationOther
PMR and VR education
PMR EducationOther
PMR education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PMR Education |
| 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. Receives: Other: PMR+VR Education |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Stress Assessment Scale
Change in pregnancy-related stress levels in pregnant women. As the score from the scale increases, stress increases.
Measured: 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.
Measured: 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.
Measured: intervention after 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Gokyildiz Surucu, Cukurova University
- Investigators
- Senay Dagilgan, Msc, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896955
- Sponsor's protocol ID
- 01.09.2023/55
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Application and Progressive Relaxation Exercise Training on Pregnant Women's Stress, Birth Affect and Birth Self-Efficacy
- ClinicalTrials.gov ID
- NCT06896955
- Acronym / sponsor ID
- 01.09.2023/55
- Conditions
- Pregnancy, Exercise, Virtual Reality
- Keywords
- Pregnancy, Exercise, progressive exercise, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMR Group | Experimental | Other: PMR Education* 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 | Other: PMR+VR Education* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Having a psychiatric disease diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMR+VR EducationPMR and VR education | Other | VR+PMR Group |
| PMR EducationPMR education | Other | PMR Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senay Dagilgan, Msc principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMR+VR Education and PMR Education in people with Pregnancy and Exercise, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sule Gokyildiz Surucu, Prof. (+90 (322) 338 64 84 ext. 1161, gokyildizsurucu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Stress Assessment Scale (time frame: pre-intervention, after 2 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.