Saint Paul's Hospital
Taoyuan, Taoyuan City, 330, Taiwan
NCT Number: NCT07329764
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Taoyuan, Taoyuan City, 330, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Women meeting the following criteria were eligible for enrollment:
Women meeting the above criteria will be enrolled after the researchers explain the research methods and objectives. Exclusion criteria include:
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.
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.
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.
Time frame: At baseline (admission for labor) and immediately after the intervention
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.
Time frame: Within 24 hours postpartum
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.
Wan-Lin Pan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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