Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia

Официальное название

The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women With Preeclampsia

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Descriptive Information Form [Срок оценки: Day 1 (Baseline, Pre-Intervention)]
• Maternal-Fetal Outcomes Follow-up Form [Срок оценки: Day 1 (Baseline, Pre-Intervention), Day 2 and 3 (Post-Intervention for intervention groups, routine monitoring for the control group)]
• Beck Anxiety Inventory (BAI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Day 1 (Baseline, before the relaxation intervention) and Day 3 (Post-intervention, after the relaxation session).]
• Satisfaction Evaluation Form (VAS) [Срок оценки: Day 3 (Post-Intervention)]
• Edinburgh Postpartum Depression Scale (EPDS) [Срок оценки: Up to 4-6 weeks postpartum (via phone follow-up)]
• Postpartum Evaluation Form [Срок оценки: Up to 4-6 weeks postpartum (via phone follow-up)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Ümraniye Training and Research Hospital — Istanbul

Публикации

• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. PMID 32443079
• 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. PMID 32699517
• 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. PMID 21968280
• 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. PMID 34464836
• 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. PMID 33436348
• 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. PMID 36383473
• 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. PMID 26678947

Идентификаторы

NCT: NCT06893510 · 2025-01/37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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