An interventional study of Virtual reality as a distraction technique in Pain, Acute and Satisfaction, Patient, sponsored by Hospital Universitario 12 de Octubre. Completed at 1 site in Spain. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Hospital Universitario 12 de Octubre · Not applicable, Interventional, and Treatment
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
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Device: Virtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset
Peak pain
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
Time frame: 5-10 minutes after the procedure
Mean pain
a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable
Time frame: 5-10 minutes after the procedure
Patient satisfaction with the information received
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
Time frame: 5-10 min before the procedure
Patient overall satisfaction with the procedure (OH)
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
Time frame: 5-10 min after the procedure
Patient satisfaction with the VR intervention
On the study group, patient satisfaction with the VR intervention was also assessed with the following 5-point scale satisfaction question "What is your level of satisfaction with the VR intervention? (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied
Time frame: 5-10 min after the procedure
Patient satisfaction with the VR intervention
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)
Time frame: 5-10 min after the procedure
Plan to share: Undecided — If needed for further studies and with the previous evaluation of the investigators IPD would be available to other researchers
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Hospital Universitario 12 de Octubre