Clinical trial NCT06424093: Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy
Official title: Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Anxiety
Keywords: hysteroscopy
Acute Pain
Anxiety
Virtual Reality
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Pain
timeFrame: 10 minutes from starting the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University
name: Amr Elhussieny, Professor
role: STUDY_CHAIR
affiliation: Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
name: Mortada El Sayed Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
name: Radwa Rsaheedy Ali, M.D
role: PRINCIPAL_INVESTIGATOR
References: