Pain, Acute, Satisfaction, Patient
Conditions
Keywords
Hysteroscopy
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.
Interventions
DEVICEVirtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset
Sponsors
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding of participants or care providers was not feasible to implement due to the nature of the intervention
Intervention model description
2 randomized groups with 60 patients per arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient satisfaction with the VR intervention | 5-10 min after the procedure | 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 |
Countries
Spain
Outcome results
None listed