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Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy (Hysteroscopy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827824
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Jesús Pelazas Hernández
David Varillas Delgado
Ignacio Cristóbal García
Information provided by (Responsible Party):
Universidad Francisco de Vitoria

Brief Summary:

Randomized intervention trial with a calculated sample size of 150 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 ...


Condition or disease Intervention/treatment Phase
Uterine Diseases Device: Hysteroscopy & virtual reality glasses Device: Hysteroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hysteroscopy & Virtual reality glasses
Hysteroscopy with use of virtual reality glasses
Device: Hysteroscopy & virtual reality glasses
Hysteroscopy. Virtual reality glasses. VAS. STAI scale.

Device: Hysteroscopy
Hysteroscopy. VAS. STAI scale.

Active Comparator: Hysteroscopy
Hysteroscopy without use of virtual reality glasses
Device: Hysteroscopy
Hysteroscopy. VAS. STAI scale.




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: Change from baseline VAS at 30 minutes. ]
    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.

  2. State-Trait Anxiety Inventory (STAI) [ Time Frame: Change from baseline STAI scale at 30 minutes. ]
    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 :
  1. Systolic and Diastolic blood pressure [ Time Frame: Changes of systolic and diastolic blood pressure from baseline at 30 minutes. ]
    Analize both blood pressures (systolic and diastolic) modifications in patients of study, experimental and active comparator groups.

  2. Cardiac frequency [ Time Frame: Changes of cardiac frequency from baseline at 30 minutes. ]
    Analize cardiac frenquence modifications in intervention group previous procedure, during the procedure and at the end of procedure.

  3. Oxygen saturation [ Time Frame: Changes of oxygen saturation from baseline at 30 minutes. ]
    Analize oxygen saturation modifications in intervention group previous procedure, during the procedure and at the end of procedure.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827824


Contacts
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Contact: David V Varillas Delgado, PhD +34 617068714 david.varillas@ufv.es
Contact: Jesús V Pelazas Hernández, MD +34 630945535 jesuspelazas@hotmail.com

Locations
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Spain
David Varillas Delgado Recruiting
Pozuelo de Alarcón, Madrid, Spain, 28224
Contact: David V Varillas Delgado, PhD    617068714    david.varillas@ufv.es   
Principal Investigator: Jesús V Pelazas Hernández, MD         
Sub-Investigator: Ignacio V Cristóbal García, PhD MD         
Sponsors and Collaborators
Universidad Francisco de Vitoria
Jesús Pelazas Hernández
David Varillas Delgado
Ignacio Cristóbal García
Investigators
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Principal Investigator: Jesús V Pelazas Hernández, MD Hospital El Escorial
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Responsible Party: Universidad Francisco de Vitoria
ClinicalTrials.gov Identifier: NCT03827824    
Other Study ID Numbers: 12.18
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Francisco de Vitoria:
Virtual Reality
Hysteroscopy
Pain
Anxiety
Additional relevant MeSH terms:
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Uterine Diseases
Genital Diseases, Female