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

NCT07329764 | Not Yet Recruiting DMC

• 1 other identifier: TYGH114028
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Childbirth Experience; Relieve Pain; Anxiety

Keywords

Virtual Reality; Labor Pain; Anxiety; Childbirth Satisfaction; Non-pharmacological Pain Management; Intrapartum Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maternal anxiety during labor as measured by the State-Trait Anxiety Inventory (STAI-S)

  At baseline (admission for labor) and immediately after the intervention

• Childbirth satisfaction as measured by the Childbirth Experience Questionnaire (CEQ)

  Within 48 hours postpartum

Study Arms (2)

Experimental: Virtual Reality Intervention

EXPERIMENTAL

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

Control: Standard Intrapartum Care

NO INTERVENTION

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

Interventions

Virtual Reality DIAGNOSTIC_TEST

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.

Experimental: Virtual Reality Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 30702436 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Labor Pain

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tian Yun Wei, master

CONTACT

886+0930967008; love88881010@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: This study uses a randomized, parallel-group interventional design. Eligible laboring women will be randomly assigned to either a virtual reality (VR) intervention group or a control group with no intervention. Participants in the VR group will receive virtual reality-based supportive care during labor, while participants in the control group will receive standard intrapartum care without additional intervention. Outcomes will be assessed and compared between the two groups.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 9, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share