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To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy 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 operative hysteroscopy 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 hysteroscopy with Vr System |
|
| Standart care | Experimental | women allocated to undergo hysteroscopy without VR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SootheVR: AppliedVR, Los Angeles, California | Device | a head-mounted display |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| eli shprecher, Prof | souraski MC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lis Maternity Hospital, Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel | |||
| Souraski MC |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| Tel Aviv |
| Israel |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |