Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women

Wan-Lin Pan

Status: Not yet enrolling

Conditions: Relieve Pain; Childbirth Experience; Anxiety

Treatments: Diagnostic Test: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07329764

TYGH114028

Details and patient eligibility

About

This study is designed to evaluate whether a virtual reality (VR) intervention can help reduce pain and anxiety and improve childbirth satisfaction among laboring women.

Eligible participants will be randomly assigned to either a VR intervention group or a control group receiving standard intrapartum care. Women in the VR group will use a virtual reality headset that provides immersive natural imagery and music during labor, while women in the control group will receive routine care without VR.

The study will compare levels of labor pain, anxiety, and childbirth satisfaction between the two groups to determine the effectiveness of the virtual reality intervention as supportive care during labor.

Full description

This randomized, parallel-group interventional study aims to evaluate the effectiveness of a virtual reality (VR) intervention as supportive care during labor. The study will be conducted among laboring women admitted for childbirth who meet the eligibility criteria.

Eligible participants will be randomly assigned to one of two groups: a virtual reality intervention group or a control group receiving standard intrapartum care without additional intervention. Randomization will be performed using an appropriate allocation method to ensure comparable groups. Due to the nature of the intervention, this study will be conducted as an open-label trial.

Participants assigned to the VR intervention group will receive virtual reality-based supportive care during labor. The intervention involves the use of a head-mounted VR device providing immersive natural imagery and calming music, intended to promote relaxation and distraction from labor-related discomfort. The VR intervention will be administered during the active phase of labor according to the study protocol.

Participants in the control group will receive routine intrapartum care in accordance with standard clinical practice, without exposure to virtual reality or other additional supportive interventions beyond usual care.

The primary outcome of the study is labor pain intensity, assessed using the Visual Analogue Scale (VAS) during the active phase of labor. Secondary outcomes include maternal anxiety during labor, measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S), and childbirth satisfaction, assessed using the Childbirth Experience Questionnaire (CEQ) within 48 hours postpartum.

Outcome measures will be compared between the intervention and control groups to determine the effectiveness of the virtual reality intervention in reducing labor pain and anxiety and improving childbirth satisfaction.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Women meeting the following criteria were eligible for enrollment:

1. Pregnant.
2. Aged 18 years or older.
3. Pregnant for more than 37 weeks.
4. Single baby born in the cephalic presentation and willing to deliver naturally.
5. Admitted to the hospital during the latent period.
6. No major medical conditions or complications during pregnancy for either mother or baby.
7. Able to hear, speak, read, and write Chinese.
8. Interested in participating in this study and agreeing to complete the questionnaire.

Women meeting the above criteria will be enrolled after the researchers explain the research methods and objectives. Exclusion criteria include:

1. Virtual reality sickness.
2. Vision or hearing problems.
3. Withdrawal from the study.
4. Maternal or fetal condition requiring emergency cesarean section.
5. Those diagnosed with migraine, epilepsy, or mental illness.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Experimental: Virtual Reality Intervention

Experimental group

Description:

Participants assigned to this group will receive a virtual reality (VR) intervention during labor. The VR intervention consists of immersive natural imagery and music delivered through a head-mounted display as supportive care during labor.

Treatment:

Diagnostic Test: Virtual Reality

Control: Standard Intrapartum Care

No Intervention group

Description:

Participants assigned to this group will receive standard intrapartum care without any additional virtual reality intervention.