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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424093
• Other study ID #: Virtual Reality Technology
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: Egymedicalpedia
• Contact: Waleed Mohamed shawky, MSC
• Phone: +201093699004
• Email: Waleed.shawky.94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 15, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety

Intervention

Procedure:
• Virtual Reality Technology
To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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