Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Dysplasia, Cervix Clinical Trial

Official title:

Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742543
• Other study ID #: 0097-21-TLV
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2022
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nadav Michaan, MD
• Phone: 972527360283
• Email: nadavmi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients under 18 years

• pregnant women

Related Conditions & MeSH terms

• Dysplasia, Cervix
• Uterine Cervical Dysplasia

Intervention

Device:
• 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

Locations

Country	Name	City	State
Israel	Lis Maternity Hospital, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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