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

Egymedicalpedia

Status: Enrolling

Conditions: Anxiety; Acute Pain

Treatments: Procedure: Virtual Reality Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT06424093

Virtual Reality Technology

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Group A: Cases Group

Experimental group

Description:

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

Treatment:

Procedure: Virtual Reality Technology

Group B: Control Group

Placebo Comparator group

Description:

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

Treatment:

Procedure: Virtual Reality Technology