Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Dysplasia, Cervix

Treatments: Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display

Study type: Interventional

Funder types: Other

Identifiers

NCT04742543

0097-21-TLV

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion criteria

• patients under 18 years
• pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual reality glasses

Experimental group

Description:

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

Treatment:

Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display

No intervention. standard treatment

No Intervention group

Description:

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)