The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Federico II University
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Respiratory rate (RR) pre procedure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see & treat philosophy.
Investigators
Brunella Zizolfi
Assistant Professor
Federico II University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Respiratory rate (RR) pre procedure
Time Frame: 1 minute before the procedure
Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Pain post procedure
Time Frame: 1 minute after the procedure
Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.
Anxiety pre procedure
Time Frame: 1 minute before the procedure
Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.
Pain pre procedure
Time Frame: 1 minute before the procedure
Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.
Heart rate (HR) pre procedure
Time Frame: 1 minute before the procedure
Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Anxiety post procedure
Time Frame: 1 minute after the procedure
Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.
Respiratory rate (RR) during procedure
Time Frame: 5 minutes after the start of the procedure
Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Heart rate (HR) during procedure
Time Frame: 5 minutes after the start of the procedure
Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Secondary Outcomes
- Satisfaction rate(5 minutes after the procedure)
- Suspension rate of procedure(During procedure)
- Time of procedure(During procedure)
- Side effects(5 minutes after the procedure)