Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia
NCT ID: NCT06893510
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
96 participants
INTERVENTIONAL
2025-09-08
2026-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Virtual Reality Application and Progressive Relaxation Exercise
NCT06896955
The Effect of Virtual Reality Glasses on Fear of Birth, Delivery Time and Non-Stress Test Results in Pregnancy in the Process of Labor
NCT05723666
The Effect of Virtual Reality Glass During Labor Process on Labor Pain, Birth Perception and Anxiety
NCT04664114
The Use of Virtual Reality and Music Therapy for Hypertensive Urgency
NCT07272486
The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women
NCT06996457
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG)
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.
Face-to-Face Progressive Muscle Relaxation
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.
Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG)
Participants will undergo 15-minute VR-assisted PMR sessions for three consecutive days (once per day) under the researcher's supervision. The VR sessions will include relaxing nature scenes combined with the researcher's PMR audio guidance. After the initial three sessions, participants will receive the same PMR audio recording and will be instructed to listen to it twice a week, logging their sessions. The researcher will conduct phone follow-ups to ensure adherence.
Virtual Reality Based Progressive Muscle Relaxation
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.
Control Group
Participants in the control group will not receive any relaxation intervention and will continue their usual daily routines.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Reality Based Progressive Muscle Relaxation
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 Relaxation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Gestational age ≥26 weeks.
* 18 years or older.
* Singleton and viable pregnancy.
* Willing to participate in the study voluntarily.
Exclusion Criteria
* 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.
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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Güzin Ünlü Suvari
M.Sc, Ph.D. Student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ergül Aslan, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
İstanbul University-Cerrahpaşa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ümraniye Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Güzin Ünlü Suvari, M.Sc.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
Bell 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.
Bernstein, 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.
Dominguez-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.
Escobar-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.
Estrella-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.
Ferguson 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.
Folk 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.
Hajesmaeel-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.
Ioannou 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.
Machado 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.
Severi 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.
Son 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-01/37
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.