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Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy (VRPAD)

Primary Purpose

Pain, Acute, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Hysteroscopy, Pain, Virtual Reality, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being over 18 years
  • Understand and accept the study procedures
  • Sign the informed consent.
  • Indication of outpatient hysteroscopy according to the care protocols of the center
  • Not taking drugs for the treatment of anxiety.

Exclusion Criteria:

  • Not being able to understand the nature of the study and / or the procedures to be followed
  • Not signing the informed consent
  • Be under the age of 18
  • Pregnancy
  • Being diagnosed with anxiety disorder or being treated with anxiolytics
  • Patients suffering from vertigo
  • Patients with epilepsy
  • Active ear infection
  • Patients with diagnosed hypertension
  • Patients with cardiovascular disease
  • Patients with psychosis or severe mental illness

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

Virtual Reality

Arm Description

Office hysteroscopy performed as the standard of care of our Hospital

Office hysteroscopy with the use of VR environment (preprocedure and during procedure)

Outcomes

Primary Outcome Measures

Pain score
Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.

Secondary Outcome Measures

Heart Rate
Changes in basal Heart Rate, maximum Heart Rate, mean Heart Rate, and final Heart Rate.
Blood Pressure
Changes in pre and postprocedure blood pressure
Skin conductace
Change between basal and maximum skin conductance levels during pocedure measured by a small sensor placed on two hand fingers. Skin conductance depends directly on the state of relaxation or stress, making it a commonly used and very precise stress indicator.

Full Information

First Posted
December 11, 2020
Last Updated
January 21, 2021
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Psious
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1. Study Identification

Unique Protocol Identification Number
NCT04721587
Brief Title
Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy
Acronym
VRPAD
Official Title
Effectiveness of Virtual Reality as a Pain and Anxiety Distraction Strategy on Office Hysteroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Psious

4. Oversight

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

5. Study Description

Brief Summary
Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results. Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure. The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anxiety
Keywords
Hysteroscopy, Pain, Virtual Reality, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Office hysteroscopy performed as the standard of care of our Hospital
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Office hysteroscopy with the use of VR environment (preprocedure and during procedure)
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
The patients of the VR Group will be subjected to the same hysteroscopy technique as the Standard of Care Group, but additionally a VR device will be applied where a distraction VR environment ("Underwater Game") will be reproduced during the exploration
Primary Outcome Measure Information:
Title
Pain score
Description
Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.
Time Frame
Intraprocedure
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Changes in basal Heart Rate, maximum Heart Rate, mean Heart Rate, and final Heart Rate.
Time Frame
Intraprocedure
Title
Blood Pressure
Description
Changes in pre and postprocedure blood pressure
Time Frame
Intraprocedure
Title
Skin conductace
Description
Change between basal and maximum skin conductance levels during pocedure measured by a small sensor placed on two hand fingers. Skin conductance depends directly on the state of relaxation or stress, making it a commonly used and very precise stress indicator.
Time Frame
Intraprocedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being over 18 years Understand and accept the study procedures Sign the informed consent. Indication of outpatient hysteroscopy according to the care protocols of the center Not taking drugs for the treatment of anxiety. Exclusion Criteria: Not being able to understand the nature of the study and / or the procedures to be followed Not signing the informed consent Be under the age of 18 Pregnancy Being diagnosed with anxiety disorder or being treated with anxiolytics Patients suffering from vertigo Patients with epilepsy Active ear infection Patients with diagnosed hypertension Patients with cardiovascular disease Patients with psychosis or severe mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Estadella
Phone
+34935537041
Email
jestadella@santpau.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Estadella Tarriel
Phone
934081052
Email
josepestadella@hotmail.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Estadella Tarriel
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Estadella
Phone
+34935537041
Email
jestadella@santpau.cat
First Name & Middle Initial & Last Name & Degree
Josep Esatdella

12. IPD Sharing Statement

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Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy

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