Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy (Hysteroscopy)
Primary Purpose
Uterine Diseases
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hysteroscopy & virtual reality glasses
Hysteroscopy
Sponsored by
About this trial
This is an interventional prevention trial for Uterine Diseases focused on measuring Virtual Reality, Hysteroscopy, Pain, Anxiety
Eligibility Criteria
Inclusion Criteria:
- Women with an established indication for diagnostic hysteroscopy according to the Spanish Society of Gynecology and Obstetrics (SEGO) criteria collected in its document of consensus, updated in 2013, with the title of "Hysteroscopy in consultation".
- Age between 18 and 75 years.
- Suitable cultural level for the understanding of the characteristics of the study.
- Signature of informed consent.
Exclusion Criteria:
- Not be within the criteria established by SEGO for the realization of a hysteroscopy diagnostic.
- Existence of contraindication for hysteroscopy.
- Present some type of disease or disability that can intervene in the object of the study: visual deficit, auditory or sensory severe, illnesses or mental syndromes.
- Having suffered seizures, loss of knowledge, or other symptoms related to epileptic disorders that discourages the use of virtual reality glasses.
- Not signature of informed consent.
Sites / Locations
- David Varillas Delgado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hysteroscopy & Virtual reality glasses
Hysteroscopy
Arm Description
Hysteroscopy with use of virtual reality glasses
Hysteroscopy without use of virtual reality glasses
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
Visual Analogue Scale: A measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.This scale is between the values 0 to 10, being 0 the greatest pain possible and 10 the least pain. It is categorized into several sections, being intense pain 0-3, moderate pain 4-7 and low pain 8-10.
State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI): A psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Each measure has a different rating scale. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always.
Secondary Outcome Measures
Systolic and Diastolic blood pressure
Analize both blood pressures (systolic and diastolic) modifications in patients of study, experimental and active comparator groups.
Cardiac frequency
Analize cardiac frenquence modifications in intervention group previous procedure, during the procedure and at the end of procedure.
Oxygen saturation
Analize oxygen saturation modifications in intervention group previous procedure, during the procedure and at the end of procedure.
Full Information
NCT ID
NCT03827824
First Posted
January 24, 2019
Last Updated
May 17, 2023
Sponsor
Universidad Francisco de Vitoria
Collaborators
Jesús Pelazas Hernández, David Varillas Delgado, Ignacio Cristóbal García, Teresa González Casado, Ignacio Cristóbal Quevedo, Agustina Alonso Bermejo, Marina Ronchas Martínez
1. Study Identification
Unique Protocol Identification Number
NCT03827824
Brief Title
Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy
Acronym
Hysteroscopy
Official Title
Intervention Study to Measure the Effect on Perception of Pain and Anxiety in Women With Indication for Diagnostic Hysteroscopy Through the Use of Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Complete collection of study patients
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Francisco de Vitoria
Collaborators
Jesús Pelazas Hernández, David Varillas Delgado, Ignacio Cristóbal García, Teresa González Casado, Ignacio Cristóbal Quevedo, Agustina Alonso Bermejo, Marina Ronchas Martínez
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
Randomized intervention trial with a calculated sample size of 90 women aged between 18 and 75 years and medical criteria for performing a diagnostic hysteroscopy according to the Gynecology and Obstetrics Spanish Society (SEGO).
Nowadays the investigators known that acute pain requires cognitive attention for its perception, a patient's state of anxiety depends on the subjective capacity to cope with the process and that environments created with virtual reality can cause a cognitive distraction that diminishes the perception of pain as well as a subjective psychological illusion that diminishes the anxiety that motivates the procedure.
For all the above, the investigators will study as a main objective the differences between the use of virtual reality through the use of virtual reality glasses "Oculus go model", to reduce the perception of pain and anxiety motivated by the performance of a outpatient hysteroscopy versus clinical practice. It is usual not to use analgesia, using the VAS pain scale and the STAI (State-Trait Anxiety Inventory) questionnaire to assess the state of anxiety before and after the test. In addition, as secondary objectives, the investigators will compare different aspects such as surgical time used, determination of vital signs, satisfaction studies ...
Detailed Description
A Cochrane review (included 32 clinical trials and 3304 patients) concluded that there was no effective and safe treatment for pain relief in patients undergoing outpatient hysteroscopy. In the same way, The Gynecology and Obstetrics Spanish Society (SEGO) discourages the routine use of analgesics prior to the test or the use of local anesthesia or sedation, since neither improves the pain nor the satisfaction of the patients in this type of test.
Nowadays, is knowed that acute pain requires cognitive attention for its perception, a patient's state of anxiety depends on the subjective capacity to cope with the process and that environments created with virtual reality can cause a cognitive distraction that diminishes the perception of pain as well as a subjective psychological illusion that diminishes the anxiety that motivates the procedure.
With all this, the investigators intend to assess through this study if patients with medical indication for diagnostic hysteroscopy can benefit from the use of Virtual Reality for the decrease in their perception of pain, anxiety or increase in the degree of satisfaction with their performance.
- Design: Randomized intervention clinical trial
- Sample: by contrast of hypothesis, a sample size of 90 women with an established medical indication for outpatient hysteroscopy was determined. They were randomized using excel software. As criteria of inclusion, those of SEGO with ages between 18 and 75 years were used. Criteria of exclusion those of the test, presenting some type of illness or disability that contraindicate the use of Virtual Reality (blindness, deafness, epilepsy, etc), voluntary wish of no inclusion or inability to understand the study.
- Methodology:
parameters to analyze:
the average decrease in the perception of pain in both groups using the Visual Analogue Scale (VAS) with determinations at the end, at 15 and 30 minutes.
the average decrease in the perception of the state of anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire prior to the performance of the test and after it.
Modifications in the degree of satisfaction with the test by means of a STAI questionnaire included in the protocol of the Gynecology Service of El Escorial University Hospital.
Changes in parameters such as blood pressure, heart rate and oxygen saturation before, during and after hysteroscopy.
The influence of different circumstances such as age, parity, on the painful perception, state of anxiety or degree of satisfaction in both arms of the study.
A 5 mm Bettocchi hysteroscope model will be used as a physiological serum distension medium and initial irrigation pressures of 75 mm Hg.
Semi-rigid 5 Charr instruments (scissors, grasping forceps and biopsy).
Oculus Go virtual reality glasses.
The recruitment time will be that necessary to obtain the sample size.
The patients will be given the STAI anxiety scale that will be completed prior to accessing the room. Once sitting on the examination table, a pulse oximeter will be placed on the left index finger, a cuff for measuring blood pressure on the right arm, and in the selected group virtual reality glasses, the first determination of blood pressure, heart rate and oxygen saturation is made at this time and will be repeated when accessing the endometrial cavity and immediately after removing the hysteroscope. After completing the test, still sitting and removed the virtual reality components will be given VAS for pain determination during the test. After dressing, the pain will be assessed using VAS at 15 and 30 minutes after the end of the test. Before leaving, a new STAI anxiety state will be delivered that will complete as well as respond to the two questions of the satisfaction protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Diseases
Keywords
Virtual Reality, Hysteroscopy, Pain, Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hysteroscopy & Virtual reality glasses
Arm Type
Experimental
Arm Description
Hysteroscopy with use of virtual reality glasses
Arm Title
Hysteroscopy
Arm Type
Active Comparator
Arm Description
Hysteroscopy without use of virtual reality glasses
Intervention Type
Device
Intervention Name(s)
Hysteroscopy & virtual reality glasses
Intervention Description
Hysteroscopy. Virtual reality glasses. VAS. STAI scale.
Intervention Type
Device
Intervention Name(s)
Hysteroscopy
Intervention Description
Hysteroscopy. VAS. STAI scale.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale: A measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.This scale is between the values 0 to 10, being 0 the greatest pain possible and 10 the least pain. It is categorized into several sections, being intense pain 0-3, moderate pain 4-7 and low pain 8-10.
Time Frame
Change from baseline VAS at 30 minutes.
Title
State-Trait Anxiety Inventory (STAI)
Description
State-Trait Anxiety Inventory (STAI): A psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Each measure has a different rating scale. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always.
Time Frame
Change from baseline STAI scale at 30 minutes.
Secondary Outcome Measure Information:
Title
Systolic and Diastolic blood pressure
Description
Analize both blood pressures (systolic and diastolic) modifications in patients of study, experimental and active comparator groups.
Time Frame
Changes of systolic and diastolic blood pressure from baseline at 30 minutes.
Title
Cardiac frequency
Description
Analize cardiac frenquence modifications in intervention group previous procedure, during the procedure and at the end of procedure.
Time Frame
Changes of cardiac frequency from baseline at 30 minutes.
Title
Oxygen saturation
Description
Analize oxygen saturation modifications in intervention group previous procedure, during the procedure and at the end of procedure.
Time Frame
Changes of oxygen saturation from baseline at 30 minutes.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with an established indication for diagnostic hysteroscopy according to the Spanish Society of Gynecology and Obstetrics (SEGO) criteria collected in its document of consensus, updated in 2013, with the title of "Hysteroscopy in consultation".
Age between 18 and 75 years.
Suitable cultural level for the understanding of the characteristics of the study.
Signature of informed consent.
Exclusion Criteria:
Not be within the criteria established by SEGO for the realization of a hysteroscopy diagnostic.
Existence of contraindication for hysteroscopy.
Present some type of disease or disability that can intervene in the object of the study: visual deficit, auditory or sensory severe, illnesses or mental syndromes.
Having suffered seizures, loss of knowledge, or other symptoms related to epileptic disorders that discourages the use of virtual reality glasses.
Women who cannot tolerate the pain at the beginning and during hysteroscopy.
Not signature of informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús V Pelazas Hernández, MD
Organizational Affiliation
Hospital El Escorial
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Varillas Delgado
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28224
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy
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