Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
- Conditions
- Pain, AcuteSatisfaction, Patient
- Interventions
- Device: Virtual reality as a distraction technique
- Registration Number
- NCT06463210
- Lead Sponsor
- Hospital Universitario 12 de Octubre
- Brief Summary
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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- Consecutive women candidates to undergo an OH
- Women aged 18 to 70 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual reality during hysteroscopy: study group Virtual reality as a distraction technique 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
- Primary Outcome Measures
Name Time Method Peak pain 5-10 minutes after the procedure a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable
Mean pain 5-10 minutes after the procedure a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable
- Secondary Outcome Measures
Name Time Method Patient satisfaction with the VR intervention 5-10 min after the procedure Patients on the VR group were also asked whether they would like to use the VR if they need to undergo another OH in the future (Yes/No)
Patient satisfaction with the information received 5-10 min before the procedure Prior to the OH all patients were interrogated about their perception of the information received about the procedure through the question "How has been the information received about the procedure?" (Not enough/Normal/Very good
Patient overall satisfaction with the procedure (OH) 5-10 min after the procedure Overall satisfaction with the OH was assessed through a question formulated as follows: "What is your level of satisfaction with the hysteroscopic procedure?", where patients could evaluate their opinion on a 5-point scale (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied
Trial Locations
- Locations (1)
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Comunidad De Madrid, Spain