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Status unknownNCT06424093Updated May 21, 2024

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

An interventional study of Virtual Reality Technology in Acute Pain and Anxiety, sponsored by Egymedicalpedia. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Acute Pain
  • Anxiety

Keywords

  • hysteroscopy
  • Acute Pain
  • Anxiety
  • Virtual Reality
03

In context

Acute Pain

908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's planned enrollment of 50 is below the median of 87 across 759 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Browse Egymedicalpedia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Group A: Cases Group

    About 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology

    Procedure: Virtual Reality Technology

  • Placebo comparator
    Group B: Control Group

    About 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology

    Procedure: Virtual Reality Technology

Interventions

  • ProcedureVirtual Reality Technology

    To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy

    Also known as: Hysteroscopy

06

What researchers measure

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)

    Time frame: 10 minutes from starting the procedure

07

Study locations

1 of 1 sites recruiting
  • Ain Shams University Hospitals
    Cairo, Egypt
    • Ahmed Eid Elsayed Zidan, MSc · Contact · dr.a.zidan87@gmail.com · +201067845518
    • Joseph Adel Ibrahim, MSc · Contact · joseph.johny2010@gmail.com · +201285515950
    • Rania Gamal Anwar, Lecturer · Principal investigator
    • Yassin Asaad Mostafa, MSc · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Nov 2024, 6 months after the start.

Of 318 interventional studies with no phase under Acute Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2024
First posted
May 21, 2024
StartActual
May 1, 2024
Primary completionEst.
Nov 1, 2024
CompletionEst.
Nov 15, 2024
Last update
May 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06424093
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
May 21, 2024
Start date
May 1, 2024
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 15, 2024 (estimated)
Last update
May 21, 2024

Study contacts

Waleed Mohamed shawky, MSC
Contact
Waleed.shawky.94@gmail.com
+201093699004
Tarek Sabry Mohamed, MSC
Contact
Tareksabry44444@gmail.com
+201096398888
Amr Elhussieny, Professor
study chair · Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University
Mortada El Sayed Ahmed, Professor
study director · Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
Radwa Rsaheedy Ali, M.D
principal investigator · Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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