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Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Primary Purpose

Dysplasia, Cervix

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SootheVR: AppliedVR, Los Angeles, California a head-mounted display
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysplasia, Cervix focused on measuring cervical dysplasia; conization; anxiety; pain; virtual reality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Lis Maternity Hospital, Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality glasses

No intervention. standard treatment

Arm 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

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)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2021
Last Updated
May 30, 2022
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04742543
Brief Title
Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia
Official Title
Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysplasia, Cervix
Keywords
cervical dysplasia; conization; anxiety; pain; virtual reality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
: Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality glasses
Arm Type
Experimental
Arm 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
Arm Title
No intervention. standard treatment
Arm Type
No Intervention
Arm 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)
Intervention Type
Device
Intervention Name(s)
SootheVR: AppliedVR, Los Angeles, California a head-mounted display
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessments of pain through pain score parameter
Description
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
Time Frame
20 minutes
Title
Assessments of pain through physiological parameters
Description
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute
Time Frame
20 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
all patients are women referred for conization of cervix uterus due to cervical dysplasia
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadav Michaan, MD
Phone
972527360283
Email
nadavmi@gmail.com
Facility Information:
Facility Name
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadav Michaan, MD
Email
nadavmi@gmail.com
First Name & Middle Initial & Last Name & Degree
eli shprecher, prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

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