Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy

NCT03827824 | Terminated

• 1 other identifier: 12.18
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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 ...

Conditions

Uterine Diseases

Keywords

Virtual Reality; Hysteroscopy; Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline VAS at 30 minutes.

• 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.

  Change from baseline STAI scale at 30 minutes.

Secondary Outcomes (3)

• Systolic and Diastolic blood pressure

  Changes of systolic and diastolic blood pressure from baseline at 30 minutes.

• Cardiac frequency

  Changes of cardiac frequency from baseline at 30 minutes.

• Oxygen saturation

  Changes of oxygen saturation from baseline at 30 minutes.

Study Arms (2)

Hysteroscopy & Virtual reality glasses

EXPERIMENTAL

Hysteroscopy with use of virtual reality glasses

Device: Hysteroscopy & virtual reality glasses; Device: Hysteroscopy

Hysteroscopy

ACTIVE COMPARATOR

Hysteroscopy without use of virtual reality glasses

Device: Hysteroscopy

Interventions

Hysteroscopy & virtual reality glasses DEVICE

Hysteroscopy. Virtual reality glasses. VAS. STAI scale.

Hysteroscopy & Virtual reality glasses

Hysteroscopy DEVICE

Hysteroscopy. VAS. STAI scale.

Hysteroscopy; Hysteroscopy & Virtual reality glasses

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead
• Jesús Pelazas Hernández: collaborator
• David Varillas Delgado: collaborator
• Ignacio Cristóbal García: collaborator
• Teresa González Casado: collaborator
• Ignacio Cristóbal Quevedo: collaborator
• Agustina Alonso Bermejo: collaborator
• Marina Ronchas Martínez: collaborator

Study Sites (1)

David Varillas Delgado

Pozuelo de Alarcón, Madrid, 28224, Spain

Location

MeSH Terms

Conditions

Uterine Diseases; Pain; Anxiety Disorders

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jesús V Pelazas Hernández, MD

  Hospital El Escorial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 1, 2019
• Study Start: March 30, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2020
• Last Updated: May 19, 2023

Record last verified: 2022-07

Locations

ES (1)