Clinical trial NCT03827824: Virtual Reality on Perception of Pain and Anxiety by 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
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Diseases
Keywords: Virtual Reality
Hysteroscopy
Pain
Anxiety
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: Jesús Pelazas Hernández
name: David Varillas Delgado
name: Ignacio Cristóbal García
name: Teresa González Casado
name: Ignacio Cristóbal Quevedo
name: Agustina Alonso Bermejo
name: Marina Ronchas Martínez
First posted: 2019-02-01
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

1. - Design: Randomized intervention clinical trial
2. - 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.
3. - 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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline VAS at 30 minutes.
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline STAI scale at 30 minutes.
Secondary outcomes:
measure: Systolic and Diastolic blood pressure
timeFrame: Changes of systolic and diastolic blood pressure from baseline at 30 minutes.
measure: Cardiac frequency
timeFrame: Changes of cardiac frequency from baseline at 30 minutes.
measure: Oxygen saturation
timeFrame: Changes of oxygen saturation from baseline at 30 minutes.
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: David Varillas Delgado
state: Madrid
Study officials:
affiliation: Hospital El Escorial
name: Jesús V Pelazas Hernández, MD
role: PRINCIPAL_INVESTIGATOR
References: