Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women
NCT ID: NCT07329764
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
92 participants
INTERVENTIONAL
2025-12-12
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Reality for Pain and Anxiety Relief in Labor
NCT07194967
Virtual Reality Effect on Labor Pain and Satisfaction
NCT05280327
The Effect of Virtual Reality Glass During Labor Process on Labor Pain, Birth Perception and Anxiety
NCT04664114
Virtual Reality in Obstetric Patients
NCT03495531
Virtual Reality to Reduce Labor Pain
NCT05167383
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Control: Standard Intrapartum Care
Participants assigned to this group will receive standard intrapartum care without any additional virtual reality intervention.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres
OTHER
Wan-Lin Pan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wan-Lin Pan
professor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TYGH114028
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.