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To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System |
|
| Standart care | No Intervention | women allocated to undergo ultrasound for the diagnosis of endometriosis without VR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SootheVR: AppliedVR, Los Angeles, California a head-mounted displa | Device | For the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be "swimming with dolphins". |
| Measure | Description | Time Frame |
|---|---|---|
| Assessments of pain through pain score parameter | Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety. | 20 minutes |
| Assessments of pain through physiological parameters | Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lis Maternity Hospital, Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42013933 | Derived | Cohen A, Levin I, Cohen Y, Gil Y, Feldman N, Bar-On S, Krajden N, Nagar R. Virtual Reality for Pain Reduction During Transvaginal Ultrasound in Women With Endometriosis: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2026 Apr 19:S1553-4650(26)00243-8. doi: 10.1016/j.jmig.2026.04.013. Online ahead of print. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017699 | Pelvic Pain |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |