Virtual Reality's Role in See&Treat Hysteroscopy
NCT Number: NCT06524934
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Cancer|Endometrial Diseases|Myoma;Uterus|Endometrial Hyperplasia
Interventions: DEVICE: Use of virtual reality during the hysteroscopic procedure
Sponsor: Federico II University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-16
Completion Date: 2024-07-15
Locations: University of Naples Federico II, Napoli, 810131, Italy

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.

Primary Outcome Measures: Pain pre 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., 1 minute before the procedure|Anxiety pre 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., 1 minute before the procedure|Pain post 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., 1 minute after the procedure|Anxiety post 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., 1 minute after the procedure|Heart rate (HR) pre procedure, Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria)., 1 minute before the procedure|Respiratory rate (RR) pre procedure, Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria)., 1 minute before the procedure|Heart rate (HR) during procedure, Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria)., 5 minutes after the start of the procedure|Respiratory rate (RR) during procedure, Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria)., 5 minutes after the start of the procedure
Secondary Outcome Measures: Suspension rate of procedure, Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons), During procedure|Time of procedure, Recording the time of procedure, During procedure|Satisfaction rate, Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could), 5 minutes after the procedure|Side effects, Reported side effects, 5 minutes after the procedure