Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy (Hysteroscopy)
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|ClinicalTrials.gov Identifier: NCT03827824|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 8, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Hysteroscopy & Virtual reality glasses
Hysteroscopy with use of virtual reality glasses
Device: Hysteroscopy & virtual reality glasses
Hysteroscopy. Virtual reality glasses. VAS. STAI scale.
Hysteroscopy. VAS. STAI scale.
Active Comparator: Hysteroscopy
Hysteroscopy without use of virtual reality glasses
Hysteroscopy. VAS. STAI scale.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827824
|Contact: David V Varillas Delgado, PhD||+34 firstname.lastname@example.org|
|Contact: Jesús V Pelazas Hernández, MD||+34 email@example.com|
|David Varillas Delgado||Recruiting|
|Pozuelo de Alarcón, Madrid, Spain, 28224|
|Contact: David V Varillas Delgado, PhD 617068714 firstname.lastname@example.org|
|Principal Investigator: Jesús V Pelazas Hernández, MD|
|Sub-Investigator: Ignacio V Cristóbal García, PhD MD|
|Principal Investigator:||Jesús V Pelazas Hernández, MD||Hospital El Escorial|