Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

NCT ID: NCT04742543

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2024-03-31

Brief Summary

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

Detailed 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.

Conditions

Dysplasia, Cervix

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Virtual reality glasses

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

No intervention. standard treatment

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patients under 18 years
• pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Nadav Michaan, MD

Role: CONTACT

nadavmi@gmail.com

972527360283

Facility Contacts

Nadav Michaan, MD

Role: primary

nadavmi@gmail.com

Other Identifiers

0097-21-TLV

Identifier Type: -

Identifier Source: org_study_id