Anxiety, Labor Pain
Conditions
Keywords
Virtual Reality, Labor Pain, Anxiety, Childbirth Satisfaction, Intrapartum Care, Maternal Mobility
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.
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.
Interventions
DIAGNOSTIC_TESTVirtual 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.
Sponsors
Wan-Lin Pan
Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labor pain intensity as measured by the Visual Analogue Scale (VAS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal anxiety during labor as measured by the State-Trait Anxiety Inventory (STAI-S) | 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. |
| Childbirth satisfaction as measured by the Mackey Childbirth Satisfaction Rating Scale (MCSRS) | 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. |
Countries
Taiwan
Outcome results
None listed