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

Istanbul University - Cerrahpasa

Status: Begins enrollment in 1 month

Conditions: Pre-Eclampsia; Fetal Monitoring; Relaxation; Virtual Reality; Maternal Health

Treatments: Other: Face-to-Face Progressive Muscle Relaxation; Other: Virtual Reality Based Progressive Muscle Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT06893510

2025-01/37

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

96 participants in 3 patient groups

Face-to-Face Progressive Muscle Relaxation Group (F2F-PMRG)

Experimental group

Description:

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.

Treatment:

Other: Face-to-Face Progressive Muscle Relaxation

Virtual Reality Progressive Muscle Relaxation Group (VR-PMRG)

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Based Progressive Muscle Relaxation

Control Group

No Intervention group

Description:

Participants in the control group will not receive any relaxation intervention and will continue their usual daily routines.