Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

Madrid Health Service

Status: Completed

Conditions: Pain, Acute; Satisfaction, Patient

Treatments: Device: Virtual reality as a distraction technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06463210

VRHSC 21/278

Details and patient eligibility

About

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.

The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH

Full description

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.

The standard care group had a trained nurse providing distraction and emotional support.

The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consecutive women candidates to undergo an OH
• Women aged 18 to 70 years old

Exclusion criteria

• Visual impairment
• Hearing impairment
• Language barrier impeding the correct explanation of the study
• Contraindication for using the VR device
• Confirmed malignant endometrial disease
• Anatomical characteristics impeding the office hysteroscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Nurse support during hysteroscopy: control group

No Intervention group

Description:

In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious. As part of our standard procedure during the OH, a trained nurse with \>10 years of experience provides distraction and emotional support to the woman. She explains the patient how to breathe and what to expect during the different moments of the procedure, thus involving the women directly in what is happening during the procedure.

Virtual reality during hysteroscopy: study group

Experimental group

Description:

In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious. A 360º video was administered to the study group through an Oculus Quest 2™ headset (Meta Platforms, CA. USA). The video was administered through the headset just before the start of the procedure. The video chosen showed a gondola ride through the canals of Venice with relaxing music played on the headset

Treatment:

Device: Virtual reality as a distraction technique