Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy
1 other identifier
interventional
50
1 country
1
Brief Summary
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 11, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2024
CompletedMay 21, 2024
May 1, 2024
6 months
May 11, 2024
May 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Pain
The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)
10 minutes from starting the procedure
Study Arms (2)
Group A: Cases Group
EXPERIMENTALAbout 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology
Group B: Control Group
PLACEBO COMPARATORAbout 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology
Interventions
To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy
Eligibility Criteria
You may qualify if:
- \- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB
You may not qualify if:
- Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.
- Psychological ,hearing or visual disorders.
- known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .
- Previous history of failed office hysteroscopy
- Patients scheduled for operative hysteroscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egymedicalpedialead
Study Sites (1)
Ain Shams University Hospitals
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amr Elhussieny, Professor
Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University
- STUDY DIRECTOR
Mortada El Sayed Ahmed, Professor
Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
- PRINCIPAL INVESTIGATOR
Radwa Rsaheedy Ali, M.D
Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2024
First Posted
May 21, 2024
Study Start
May 1, 2024
Primary Completion
November 1, 2024
Study Completion
November 15, 2024
Last Updated
May 21, 2024
Record last verified: 2024-05