AnxietyNCT07329764
Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women
A study testing Virtual Reality in people with Anxiety and Labor Pain, run by Wan-Lin Pan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Labor Pain
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Women meeting the following criteria were eligible for enrollment:
- Pregnant.
- Aged 18 years or older.
- Pregnant for more than 37 weeks.
- Single baby born in the cephalic presentation and willing to deliver naturally.
- Admitted to the hospital during the latent period.
- No major medical conditions or complications during pregnancy for either mother or baby.
- Able to hear, speak, read, and write Chinese.
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety, Labor Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Labor Pain, Anxiety, Childbirth Satisfaction, Intrapartum Care, Maternal Mobility
- Medical subject headings
- Anxiety Disorders, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the active phase of labor
Labour pain intensity
Labour pain intensity was assessed using a numerical rating scale ranging from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Immediately after the intervention
Secondary outcomes (2)
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.
Measured: At baseline (admission for labor) and immediately after the intervention
Childbirth satisfaction as measured by the Mackey Childbirth Satisfaction Rating Scale (MCSRS)
Childbirth satisfaction will be assessed using the 32-item Mackey Childbirth Satisfaction Rating Scale (MCSRS). Items are rated on a 5-point Likert scale, with total scores ranging from 32 to 160; higher scores indicate greater childbirth satisfaction.
Measured: Within 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start16 Dec 2025
- Primary completion31 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wan-Lin Pan
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres
- Responsible party
- Sponsor-investigator, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329764
- Sponsor's protocol ID
- TYGH114028
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30702436
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women
- ClinicalTrials.gov ID
- NCT07329764
- Acronym / sponsor ID
- TYGH114028
- Conditions
- Anxiety, Labor Pain
- Keywords
- Virtual Reality, Labor Pain, Anxiety, Childbirth Satisfaction, Intrapartum Care, Maternal Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Wan-Lin PanUniversity, hospital or other
- Collaborators
- Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Virtual Reality Intervention | Experimental | Diagnostic Test: Virtual RealityParticipants 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. |
| Control: Standard Intrapartum Care | No intervention | –Participants assigned to this group will receive standard intrapartum care without any additional virtual reality intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual 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. | Diagnostic test | Experimental: Virtual Reality Intervention |
Primary outcome
Labor pain intensity as measured by the Visual Analogue Scale (VAS)
Time frame: During the active phase of labor
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.
Labour pain intensity
Time frame: Immediately after the intervention
Labour pain intensity was assessed using a numerical rating scale ranging from 0 to 10, with higher scores indicating greater pain intensity.
2 secondary outcomes
Maternal anxiety during labor as measured by the State-Trait Anxiety Inventory (STAI-S)
Time frame: At baseline (admission for labor) and immediately after the intervention
Childbirth satisfaction as measured by the Mackey Childbirth Satisfaction Rating Scale (MCSRS)
Time frame: Within 24 hours postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 30702436Birckhead 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Anxiety and Labor Pain, run by Wan-Lin Pan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain intensity as measured by the Visual Analogue Scale (VAS) (time frame: During the active phase of labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.