Status:
TERMINATED
Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy
Lead Sponsor:
Universidad Francisco de Vitoria
Collaborating Sponsors:
Jesús Pelazas Hernández
David Varillas Delgado
Conditions:
Uterine Diseases
Eligibility:
FEMALE
18-75 years
Phase:
NA
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 Obste...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03827824
Start Date
March 30 2019
End Date
December 31 2020
Last Update
May 19 2023
Active Locations (1)
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1
David Varillas Delgado
Pozuelo de Alarcón, Madrid, Spain, 28224