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临床试验/NCT07669090
NCT07669090已完成不适用

The Effect of Virtual Reality and Relaxation Exercise on Physiological Parameters and Anxiety During The Non Stress Test

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1

研究概览

简要总结

Aim:

This randomized controlled trial aimed to compare the effectiveness of virtual reality and progressive muscle relaxation exercise in reducing anxiety during the non-stress test (NST) and to evaluate their effects on maternal physiological parameters in high-risk pregnant women.

Materials and Methods:

The study was conducted as a randomized controlled trial between March 2025 and August 2025 at Kanuni Sultan Süleyman Training and Research Hospital with 126 high-risk pregnant women. Participants were randomly assigned to three groups (42 per group): virtual reality, progressive muscle relaxation exercise, and control group.

During NST monitoring, participants in the virtual reality group received VR headset-based immersive audiovisual stimulation, while participants in the progressive muscle relaxation group performed guided relaxation exercises. The control group received routine NST monitoring without any additional intervention.

Data were collected using the Informed Consent Form, Pregnant Woman Information Form, Non-Stress Test Follow-up Form, Physiological Parameters Follow-up Form, Visual Analog Scale (VAS), and State-Trait Anxiety Inventory (STAI Form TX-I). The STAI, VAS, and physiological parameters were measured before and after NST, while fetal NST parameters were recorded during the procedure.

详细描述

Background and Rationale

Non-stress test (NST) is a commonly used antenatal surveillance method in high-risk pregnancies to evaluate fetal well-being. However, the procedure may increase maternal anxiety and discomfort due to prolonged immobility and concern about fetal health. Elevated anxiety during NST may also influence maternal physiological responses.

Non-pharmacological interventions such as virtual reality (VR) and progressive muscle relaxation exercise (PMRE) are increasingly used in clinical settings to reduce anxiety and improve physiological stability. VR provides immersive multisensory distraction through audiovisual stimulation, while PMRE reduces sympathetic nervous system activity through systematic muscle tension and relaxation cycles.

Although both interventions have been shown to reduce anxiety in different clinical populations, limited evidence exists comparing VR and PMRE within the same randomized controlled framework during NST in high-risk pregnant women.

Aim of the Study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants who meet all of the following criteria will be eligible for inclusion:
  • Aged 18 years or older;
  • Able to read, write, and understand Turkish;
  • At ≥28 weeks of gestation;
  • Having a singleton pregnancy;
  • Having eaten, emptied the bladder, and refrained from smoking and alcohol consumption for at least 2 hours before the non-stress test (NST) procedure;
  • Diagnosed by a physician with a high-risk pregnancy, including but not limited to preeclampsia, gestational diabetes mellitus, gestational hypertension, chronic hypertension, type 1 or type 2 diabetes mellitus, decreased fetal movement, premature rupture of membranes, threatened preterm birth, intrauterine growth restriction (IUGR), small for gestational age (SGA), oligohydramnios, or polyhydramnios.

排除标准

  • Participants meeting any of the following criteria will be excluded:
  • Having a physical or mental condition that may impair communication;
  • Having a medical condition that may prevent participation in the intervention (e.g., musculoskeletal disorders, asthma);
  • Receiving magnesium sulfate (MgSO₄) treatment or having received MgSO₄ within the previous 2 hours.
  • Withdrawal Criteria
  • Participants will be withdrawn from the study if they:
  • Request to withdraw or no longer wish to continue participation in the study;
  • Are assigned to an intervention group and fail to participate in at least 80% of the intervention sessions.

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Korur

Principal Investigator, Midwife

Istanbul University - Cerrahpasa

研究点 (1)

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