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To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia
A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality glasses | Experimental | Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure with Virtual reality glasses on |
|
| No intervention. standard treatment | No Intervention | Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure without virtual reality glasses (no intervention) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SootheVR: AppliedVR, Los Angeles, California a head-mounted display | Device | For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be "swimming with dolphins" or any other content chosen by the participant |
| 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 in which 0 is no pain and 10 is the worst imaginable pain | 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 | 20 minutes |
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Inclusion Criteria:
Patients over 18 years referred for conization of cervix due to cervical dysplasia
Exclusion Criteria:
all patients are women referred for conization of cervix uterus due to cervical dysplasia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadav Michaan, MD | Contact | 972527360283 | nadavmi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lis Maternity Hospital, Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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: Parallel Assignment
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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 |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |