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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Childbirth Experience; Relieve Pain
• Intervention / Treatment: Diagnostic test: Virtual Reality

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian Yun Wei, master; Phone Number: 886+0930967008; Email: love88881010@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Virtual Reality Intervention; 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.	Diagnostic test: Virtual Reality; Virtual reality interventions offer a promising avenue for addressing the challenges faced by laboring women in Taiwan, particularly in the context of nursing shortages. By effectively reducing pain, anxiety, and improving childbirth satisfaction, these interventions present a cost-effective and easily implementable solution with multiple benefits.
No Intervention: Control: Standard Intrapartum Care; Participants assigned to this group will receive standard intrapartum care without any additional virtual reality intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor pain intensity as measured by the Visual Analogue Scale (VAS)	Labor pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at predefined time points during the active phase of labor. Mean VAS scores will be calculated and compared between groups.	During the active phase of labor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal anxiety during labor as measured by the State-Trait Anxiety Inventory (STAI-S)	Maternal anxiety will be measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S). Scores range from 20 to 80, with higher scores indicating greater anxiety. Mean scores will be analysed at each assessment point.	At baseline (admission for labor) and immediately after the intervention
Childbirth satisfaction as measured by the Childbirth Experience Questionnaire (CEQ)	Childbirth satisfaction will be assessed using the Childbirth Experience Questionnaire (CEQ). Total and domain scores will be calculated according to the scoring guidelines, with higher scores indicating greater satisfaction.	Within 48 hours postpartum

Collaborators and Investigators

• Sponsor: Wan-Lin Pan
• Collaborators: Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres

Publications and helpful links

General Publications

• Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.

Study record dates

Study Major Dates

• Study Start (Estimated): December 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Virtual Reality; Labor Pain; Non-pharmacological Pain Management; Childbirth Satisfaction; Intrapartum Care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Labor Pain; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Exergaming
• Other Study ID Numbers: TYGH114028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No