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NCT06893510 | NOT YET RECRUITING | Pre-Eclampsia

Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women with Preeclampsia
Sponsor:

Istanbul University - Cerrahpasa

Information provided by (Responsible Party):

Güzin famous suvari

Brief 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 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.

Condition or disease

Pre-Eclampsia

Maternal Health

Relaxation

Virtual Reality

Fetal Monitoring

Intervention/treatment

Virtual Reality Based Progressive Muscle Relaxation

Face-to-Face Progressive Muscle Relaxation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 96 participants
Masking : SINGLE
Masking Description : This study employs a single-blind design, where participants will be unaware of their assigned intervention group (VR-based progressive muscle relaxation or in-person progressive muscle relaxation). However, researcher administering the interventions will be informed of group assignments. To ensure ethical compliance, separate informed consent forms have been prepared for each group, detailing the intervention.
Primary Purpose : SUPPORTIVE_CARE
Official Title : The Effect of Virtual Reality-Based and Face-to-Face Relaxation Programs on Maternal and Fetal Outcomes in Pregnant Women with Preeclampsia
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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.
Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women with Preeclampsia

Location Details

NCT06893510

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