Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04742543

Enrollment

100

Registered

2021-02-08

Start date

2022-05-19

Completion date

2024-03-31

Last updated

2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia, Cervix

Keywords

cervical dysplasia; conization; anxiety; pain; virtual reality

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.

Interventions

DEVICESootheVR: 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

: Parallel Assignment

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Assessments of pain through pain score parameter	20 minutes	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
Assessments of pain through physiological parameters	20 minutes	Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute

Countries

Israel

Contacts

Primary ContactNadav Michaan, MD

nadavmi@gmail.com972527360283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026