Pre-EclampsiaNCT06893510
Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia
A study testing Virtual Reality Based Progressive Muscle Relaxation and Face-to-Face Progressive Muscle Relaxation in people with Pre-Eclampsia and Maternal Health, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. It is clinically characterized by elevated blood pressure (≥140/90 mmHg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, Maternal Health, Relaxation
- What is being tested?
- Virtual Reality Based Progressive Muscle Relaxation and Face-to-Face Progressive Muscle Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 1 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with a diagnosis of preeclampsia.
- Gestational age ≥26 weeks.
- 18 years or older.
- Singleton and viable pregnancy.
- Willing to participate in the study voluntarily.
Who cannot join
- Multiple pregnancy.
- Pregnancy achieved through assisted reproductive technologies.
- Hearing or vision impairment in the pregnant individual.
- Fetal distress requiring emergency intervention.
- HELLP Syndrome or Eclampsia.
- History of vertigo.
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- Withdrawal Criteria:
- Cases where live birth does not occur.
- Participants who voluntarily withdraw from the study.
- Participants whose general health condition deteriorates during the intervention.
- Participants experiencing side effects from virtual reality headset use (e.g., dizziness, nausea, headache).
- Participants who do not practice progressive muscle relaxation at least once a week after the intervention.
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, 1 recruiting
- Recruiting
Ümraniye Training and Research Hospital
Istanbul
Güzin Ünlü Suvari, M.Sc.
About this study
Official title: The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women With Preeclampsia
Preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. It is clinically characterized by elevated blood pressure (≥140/90 mmHg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and cerebral symptoms. This condition poses significant risks for both maternal and fetal health, increasing the likelihood of organ damage, preterm birth, and long-term cardiovascular and neurodevelopmental complications. Non-pharmacological interventions, including relaxation techniques, have been explored for symptom management. Progressive muscle relaxation (PMR) has shown efficacy in reducing stress, anxiety, and blood pressure. Recently, virtual reality (VR)-based relaxation techniques have gained attention for enhancing stress relief and improving health outcomes. This study aims to compare the effects of VR-based PMR with in-person PMR on maternal and fetal outcomes in preeclamptic pregnancies.
- Conditions
- Pre-Eclampsia, Maternal Health, Relaxation, Virtual Reality, Fetal Monitoring
- Being tested
- Virtual Reality Based Progressive Muscle Relaxation, Face-to-Face Progressive Muscle Relaxation
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Based Progressive Muscle RelaxationOther
Participants engage in progressive muscle relaxation exercises using a virtual reality headset that provides immersive visual and auditory relaxation content. Sessions are conducted under researcher supervision, followed by self-guided practice using an audio recording.
Face-to-Face Progressive Muscle RelaxationOther
Participants practice progressive muscle relaxation exercises in a traditional face-to-face setting, guided by a researcher. Initial supervised sessions are complemented by self-guided practice using an audio recording.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG) | Experimental | Participants in this group will engage in 15-minute progressive muscle relaxation (PMR) exercises guided by the researcher for three consecutive days (once per day). To promote continued practice, participants will receive an audio recording of the PMR session, narrated by the researcher. After the initial three supervised sessions, they will be asked to listen to this recording twice a week and log their practice on a provided tracking sheet. The researcher will follow up with participants via phone calls to monitor compliance. Receives: Other: Face-to-Face Progressive Muscle Relaxation |
| Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG) | Experimental | Participants will undergo 15-minute VR-assisted PMR sessions for three consecutive days (once per day) under the researcher's supervision. During the VR sessions, participants will be exposed to relaxing nature scenes and sounds while simultaneously engaging in researcher-guided progressive muscle relaxation (PMR) exercises. After the initial three sessions, participants will receive an audio recording of the PMR session and will be instructed to listen to it twice a week, logging their sessions. The researcher will conduct phone follow-ups to ensure adherence. Receives: Other: Virtual Reality Based Progressive Muscle Relaxation |
| Control Group | No intervention | Participants in the control group will not receive any relaxation intervention and will continue their usual daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form
A researcher-developed questionnaire designed to collect sociodemographic and obstetric data based on the literature.
Measured: Day 1 (Baseline, Pre-Intervention)
Maternal-Fetal Outcomes Follow-up Form
Tracked using a researcher-developed follow-up form, including maternal vital signs and Non-Stress Test (NST) parameters.
Measured: Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)
Beck Anxiety Inventory (BAI)
Developed by Beck, Steer, Epstein, and Brown in 1988 and adapted into Turkish by Ulusoy et al. in 1998, this 21-item Likert-type scale measures anxiety levels. Each item is scored between 0 and 3, with total scores ranging from 0 to 63. Higher scores indicate higher levels of anxiety. The Turkish version has a Cronbach's alpha of 0.93, indicating high internal consistency. Factor analysis suggests two subscales: Subjective Symptoms and Somatic Symptoms.
Measured: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Prenatal Comfort Scale (PCS)
Originally developed by Takeishi et al. in 2011 in Japan and later revised by Nakamura et al. in 2015 to a 15-item version, this scale measures prenatal comfort across five subscales: Partner's Role in Fatherhood, Fetal Interaction, Social Support, Maternal Role Adaptation, and Awareness of Pregnancy Changes. The 6-point Likert-type scale ranges from 0 (strongly disagree) to 5 (strongly agree), with higher scores indicating higher comfort levels. The scale has a Cronbach's alpha of 0.95 in the original study and 0.82 in the Turkish adaptation.
Measured: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Heart Rate Variability (HRV) Measurement via Photoplethysmography (PPG)
A non-invasive test used to assess physiological stress levels by measuring heart rate variability (HRV) through a photoplethysmography (PPG) sensor placed on the fingertip.
Measured: Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).
Satisfaction Evaluation Form (VAS)
A researcher-developed form assessing participants' overall satisfaction with the intervention, perceived anxiety and stress reduction, and general experience. (only for intervention groups)
Measured: Day 3 (Post-Intervention)
Edinburgh Postpartum Depression Scale (EPDS)
eveloped by Cox et al. in 1987 and adapted into Turkish by Engindeniz et al. in 1996, this 10-item, 4-point Likert-type self-report scale assesses postpartum depression risk. Scores range from 0 to 30, with a cut-off point of 13. Internal consistency in the Turkish adaptation is 0.79, with a sensitivity of 0.84 and specificity of 0.88.
Measured: Up to 4-6 weeks postpartum (via phone follow-up)
Postpartum Evaluation Form
A researcher-developed form assessing delivery type, maternal and neonatal health parameters, and newborn evaluations based on literature
Measured: Up to 4-6 weeks postpartum (via phone follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start8 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies 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
- Model description
- This study follows a parallel-group design, where participants are randomly assigned to one of three independent groups: Face-to-Face Progressive Muscle Relaxation (F2F-PMRG), Virtual Reality Progressive Muscle Relaxation (VR-PMRG), or the Control Group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Ünlü Suvari, Istanbul University - Cerrahpasa
- Investigators
- Ergül Aslan, Prof. Dr., Principal investigator, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893510
- Sponsor's protocol ID
- 2025-01/37
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be stored in an online database (e.g., Mendeley). Data will be available upon request after the study results are published by the researchers.
Publications
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
PubMed 32443079Bell IH, Nicholas J, Alvarez-Jimenez M, Thompson A, Valmaggia L. Virtual reality as a clinical tool in mental health research and practice . Dialogues Clin Neurosci. 2020 Jun;22(2):169-177. doi: 10.31887/DCNS.2020.22.2/lvalmaggia.
PubMed 32699517Bernstein, D. A., Borkovec, T. D., & Hazlett-Stevens, H. (2000). New directions in progressive relaxation training: A guidebook for helping professionals. Praeger Publishing.
Chuang LL, Lin LC, Cheng PJ, Chen CH, Wu SC, Chang CL. The effectiveness of a relaxation training program for women with preterm labour on pregnancy outcomes: a controlled clinical trial. Int J Nurs Stud. 2012 Mar;49(3):257-64. doi: 10.1016/j.ijnurstu.2011.09.007. Epub 2011 Oct 2.
PubMed 21968280Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14.
PubMed 34464836Escobar-Bermudez A, Bejarano-Beltran MP. Experiences of women with preeclampsia in an Obstetric Intensive Care Unit in Colombia. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):166-174. doi: 10.1016/j.enfcli.2020.11.003. Epub 2021 Jan 9. English, Spanish.
PubMed 33436348Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.
PubMed 36383473Ferguson C, Davidson PM, Scott PJ, Jackson D, Hickman LD. Augmented reality, virtual reality and gaming: an integral part of nursing. Contemp Nurse. 2015;51(1):1-4. doi: 10.1080/10376178.2015.1130360. Epub 2016 Jan 14. No abstract available.
PubMed 26678947Folk DM. Hypertensive Disorders of Pregnancy: Overview and Current Recommendations. J Midwifery Womens Health. 2018 May;63(3):289-300. doi: 10.1111/jmwh.12725. Epub 2018 May 15.
PubMed 29764001Hajesmaeel-Gohari S, Sarpourian F, Shafiei E. Virtual reality applications to assist pregnant women: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):249. doi: 10.1186/s12884-021-03725-5.
PubMed 33765969Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec.
PubMed 33415290Machado MSR, Bertagnolli TV, Veiga ECA, Ferreira CJH, Duarte G, Machado JSR, Carvalho R. Multiprofessional care promotes of quality of life in pregnant women with preeclampsia: a cross-sectional study. Clinics (Sao Paulo). 2020 Oct 26;75:e1951. doi: 10.6061/clinics/2020/e1951. eCollection 2020.
PubMed 33146357Severi FM, Prattichizzo D, Casarosa E, Barbagli F, Ferretti C, Altomare A, Vicino A, Petraglia F. Virtual fetal touch through a haptic interface decreases maternal anxiety and salivary cortisol. J Soc Gynecol Investig. 2005 Jan;12(1):37-40. doi: 10.1016/j.jsgi.2004.07.006.
PubMed 15629669Son H, Ross A, Mendoza-Tirado E, Lee LJ. Virtual Reality in Clinical Practice and Research: Viewpoint on Novel Applications for Nursing. JMIR Nurs. 2022 Mar 16;5(1):e34036. doi: 10.2196/34036.
PubMed 35293870
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT06893510
- Acronym / sponsor ID
- 2025-01/37
- Conditions
- Pre-Eclampsia, Maternal Health, Relaxation, Virtual Reality, Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 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.
Preeclampsia, affecting 2-8% of pregnancies globally, is a leading hypertensive disorder in pregnancy. It is clinically characterized by elevated blood pressure (≥140/90 mmHg) after the 20th gestational week, often accompanied by proteinuria and systemic complications such as thrombocytopenia, liver dysfunction, and cerebral symptoms. This condition poses significant risks for both maternal and fetal health, increasing the likelihood of organ damage, preterm birth, and long-term cardiovascular and neurodevelopmental complications. Non-pharmacological interventions, including relaxation techniques, have been explored for symptom management. Progressive muscle relaxation (PMR) has shown efficacy in reducing stress, anxiety, and blood pressure. Recently, virtual reality (VR)-based relaxation techniques have gained attention for enhancing stress relief and improving health outcomes. This study aims to compare the effects of VR-based PMR with in-person PMR on maternal and fetal outcomes in preeclamptic pregnancies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study follows a parallel-group design, where participants are randomly assigned to one of three independent groups: Face-to-Face Progressive Muscle Relaxation (F2F-PMRG), Virtual Reality Progressive Muscle Relaxation (VR-PMRG), or the Control Group.
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG) | Experimental | Other: Face-to-Face Progressive Muscle RelaxationParticipants in this group will engage in 15-minute progressive muscle relaxation (PMR) exercises guided by the researcher for three consecutive days (once per day). To promote continued practice, participants will receive an audio recording of the PMR session, narrated by the researcher. After the initial three supervised sessions, they will be asked to listen to this recording twice a week and log their practice on a provided tracking sheet. The researcher will follow up with participants via phone calls to monitor compliance. |
| Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG) | Experimental | Other: Virtual Reality Based Progressive Muscle RelaxationParticipants will undergo 15-minute VR-assisted PMR sessions for three consecutive days (once per day) under the researcher's supervision. During the VR sessions, participants will be exposed to relaxing nature scenes and sounds while simultaneously engaging in researcher-guided progressive muscle relaxation (PMR) exercises. After the initial three sessions, participants will receive an audio recording of the PMR session and will be instructed to listen to it twice a week, logging their sessions. The researcher will conduct phone follow-ups to ensure adherence. |
| Control Group | No intervention | –Participants in the control group will not receive any relaxation intervention and will continue their usual daily routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized with a diagnosis of preeclampsia.
- Gestational age ≥26 weeks.
- 18 years or older.
- Singleton and viable pregnancy.
- Willing to participate in the study voluntarily.
Key exclusion criteria (12 listed)
- Multiple pregnancy.
- Pregnancy achieved through assisted reproductive technologies.
- Hearing or vision impairment in the pregnant individual.
- Fetal distress requiring emergency intervention.
- HELLP Syndrome or Eclampsia.
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 |
|---|---|---|
| Virtual Reality Based Progressive Muscle RelaxationParticipants engage in progressive muscle relaxation exercises using a virtual reality headset that provides immersive visual and auditory relaxation content. Sessions are conducted under researcher supervision, followed by self-guided practice using an audio recording. | Other | Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG) |
| Face-to-Face Progressive Muscle RelaxationParticipants practice progressive muscle relaxation exercises in a traditional face-to-face setting, guided by a researcher. Initial supervised sessions are complemented by self-guided practice using an audio recording. | Other | Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG) |
Primary outcome
Descriptive Information Form
Time frame: Day 1 (Baseline, Pre-Intervention)
A researcher-developed questionnaire designed to collect sociodemographic and obstetric data based on the literature.
Maternal-Fetal Outcomes Follow-up Form
Time frame: Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)
Tracked using a researcher-developed follow-up form, including maternal vital signs and Non-Stress Test (NST) parameters.
Beck Anxiety Inventory (BAI)
Time frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Developed by Beck, Steer, Epstein, and Brown in 1988 and adapted into Turkish by Ulusoy et al. in 1998, this 21-item Likert-type scale measures anxiety levels. Each item is scored between 0 and 3, with total scores ranging from 0 to 63. Higher scores indicate higher levels of anxiety. The Turkish version has a Cronbach's alpha of 0.93, indicating high internal consistency. Factor analysis suggests two subscales: Subjective Symptoms and Somatic Symptoms.
Prenatal Comfort Scale (PCS)
Time frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 3 (Post-intervention for intervention groups, after routine assessment for control group).
Originally developed by Takeishi et al. in 2011 in Japan and later revised by Nakamura et al. in 2015 to a 15-item version, this scale measures prenatal comfort across five subscales: Partner's Role in Fatherhood, Fetal Interaction, Social Support, Maternal Role Adaptation, and Awareness of Pregnancy Changes. The 6-point Likert-type scale ranges from 0 (strongly disagree) to 5 (strongly agree), with higher scores indicating higher comfort levels. The scale has a Cronbach's alpha of 0.95 in the original study and 0.82 in the Turkish adaptation.
Heart Rate Variability (HRV) Measurement via Photoplethysmography (PPG)
Time frame: Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).
A non-invasive test used to assess physiological stress levels by measuring heart rate variability (HRV) through a photoplethysmography (PPG) sensor placed on the fingertip.
Satisfaction Evaluation Form (VAS)
Time frame: Day 3 (Post-Intervention)
A researcher-developed form assessing participants' overall satisfaction with the intervention, perceived anxiety and stress reduction, and general experience. (only for intervention groups)
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: Up to 4-6 weeks postpartum (via phone follow-up)
eveloped by Cox et al. in 1987 and adapted into Turkish by Engindeniz et al. in 1996, this 10-item, 4-point Likert-type self-report scale assesses postpartum depression risk. Scores range from 0 to 30, with a cut-off point of 13. Internal consistency in the Turkish adaptation is 0.79, with a sensitivity of 0.84 and specificity of 0.88.
Postpartum Evaluation Form
Time frame: Up to 4-6 weeks postpartum (via phone follow-up)
A researcher-developed form assessing delivery type, maternal and neonatal health parameters, and newborn evaluations based on literature
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 10 Jun 2026.
- Background: PubMed 32443079Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
- Background: PubMed 32699517Bell IH, Nicholas J, Alvarez-Jimenez M, Thompson A, Valmaggia L. Virtual reality as a clinical tool in mental health research and practice . Dialogues Clin Neurosci. 2020 Jun;22(2):169-177. doi: 10.31887/DCNS.2020.22.2/lvalmaggia.
- BackgroundBernstein, D. A., Borkovec, T. D., & Hazlett-Stevens, H. (2000). New directions in progressive relaxation training: A guidebook for helping professionals. Praeger Publishing.
- Background: PubMed 21968280Chuang LL, Lin LC, Cheng PJ, Chen CH, Wu SC, Chang CL. The effectiveness of a relaxation training program for women with preterm labour on pregnancy outcomes: a controlled clinical trial. Int J Nurs Stud. 2012 Mar;49(3):257-64. doi: 10.1016/j.ijnurstu.2011.09.007. Epub 2011 Oct 2.
- Background: PubMed 34464836Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14.
- Background: PubMed 33436348Escobar-Bermudez A, Bejarano-Beltran MP. Experiences of women with preeclampsia in an Obstetric Intensive Care Unit in Colombia. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):166-174. doi: 10.1016/j.enfcli.2020.11.003. Epub 2021 Jan 9. English, Spanish.
- Background: PubMed 36383473Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.
- Background: PubMed 26678947Ferguson C, Davidson PM, Scott PJ, Jackson D, Hickman LD. Augmented reality, virtual reality and gaming: an integral part of nursing. Contemp Nurse. 2015;51(1):1-4. doi: 10.1080/10376178.2015.1130360. Epub 2016 Jan 14. No abstract available.
- Background: PubMed 29764001Folk DM. Hypertensive Disorders of Pregnancy: Overview and Current Recommendations. J Midwifery Womens Health. 2018 May;63(3):289-300. doi: 10.1111/jmwh.12725. Epub 2018 May 15.
- Background: PubMed 33765969Hajesmaeel-Gohari S, Sarpourian F, Shafiei E. Virtual reality applications to assist pregnant women: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):249. doi: 10.1186/s12884-021-03725-5.
- Background: PubMed 33415290Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec.
- Background: PubMed 33146357Machado MSR, Bertagnolli TV, Veiga ECA, Ferreira CJH, Duarte G, Machado JSR, Carvalho R. Multiprofessional care promotes of quality of life in pregnant women with preeclampsia: a cross-sectional study. Clinics (Sao Paulo). 2020 Oct 26;75:e1951. doi: 10.6061/clinics/2020/e1951. eCollection 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be stored in an online database (e.g., Mendeley). Data will be available upon request after the study results are published by the researchers.
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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.
Ergül Aslan, Prof. Dr. principal investigator
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Based Progressive Muscle Relaxation and Face-to-Face Progressive Muscle Relaxation in people with Pre-Eclampsia and Maternal Health, run by Istanbul University - Cerrahpasa 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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 Güzin Ünlü Suvari, M.Sc. (+902165004429, guzin.unlu@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Information Form (time frame: Day 1 (Baseline, Pre-Intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893510, which also lists 14 linked publications.
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 10 Jun 2026.