Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy

May 16, 2024 updated by: Egymedicalpedia

Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.

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. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.

Although a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.

The studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.

Nonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rania Gamal Anwar, Lecturer
        • Sub-Investigator:
          • Yassin Asaad Mostafa, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Cases Group
About 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology
Procedure: Virtual Reality Technology
To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy
Other Names:
  • Hysteroscopy
Placebo Comparator: Group B: Control Group
About 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology
Procedure: Virtual Reality Technology
To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy
Other Names:
  • Hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pain
Time Frame: 10 minutes from starting the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtual Reality Technology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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