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| Name | Class |
|---|---|
| Saint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De Chartres | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control: Standard Intrapartum Care | No Intervention | Participants assigned to this group will receive standard intrapartum care without any additional virtual reality intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (admission for labor) and immediately after the intervention |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Yun Wei, master | Contact | 886+0930967008 | love88881010@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30702436 | Result | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000088544 | Exergaming |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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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.
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| Childbirth satisfaction as measured by the Childbirth Experience Questionnaire (CEQ) | Childbirth satisfaction will be assessed using the Childbirth Experience Questionnaire (CEQ). Total and domain scores will be calculated according to the scoring guidelines, with higher scores indicating greater satisfaction. | Within 48 hours postpartum |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |