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The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.
Participants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).
Anxiety and pain levels will be assessed immediately before and after the TVUS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR- TVUS Group | Experimental | Participants undergo TVUS while using immersive virtual reality distraction |
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| Contro Group - Standard TVUS | No Intervention | Participants undergo standard TVUS, without virtual reality or any additional distraction intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality - based distraction | Behavioral | Participants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating | Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination | From immediately before the TVUS to immediately after completion of the examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity measured by Visual Analog scale (VAS) | Pain intensity is assessed using a VAS . VAS is a self-reported measure of pain expressed as a number on a continuum between 1 ("no pain") and 10 ("worst pain"). | From immediately before the TVUS to immediately after completion of the examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endometriosis Center, Sheba Medical Center | Ramat Gan | Central District | Israel |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Participants Are randomized to undergo either transvaginal ultrasound with virtual reality distraction or standard transvaginal ultrasound without virtual reality. Each participant is assigned to a single study arm for the duration of the study.
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This is an open-label study.
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| Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS |
Heart rate and blood pressure level are measured as objective measures of emotional distress and pain. |
| The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination. |
| D000091662 | Genital Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |