Virtual Reality's Role in See&Treat Hysteroscopy

Not Applicable

Completed

• Conditions: Endometrial Diseases; Endometrial Cancer; Endometrial Hyperplasia; Myoma;Uterus
• Interventions: Device: Use of virtual reality during the hysteroscopic procedure

• Registration Number: NCT06524934
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Status Verified: 2024-07
• Primary Completion: 2024-07-06
• Study Completion: 2024-07-15
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	Use of virtual reality during the hysteroscopic procedure	The patients in this group undergo the procedure using virtual reality.

Primary Outcome Measures

Name	Time	Method
Respiratory rate (RR) pre procedure	1 minute before the procedure	Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Pain post procedure	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	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.
Heart rate (HR) pre procedure	1 minute before the procedure	Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Pain pre procedure	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.
Anxiety post procedure	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	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	5 minutes after the start of the procedure	Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).

Secondary Outcome Measures

Name	Time	Method
Satisfaction rate	5 minutes after the procedure	Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could)
Suspension rate of procedure	During procedure	Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons)
Time of procedure	During procedure	Recording the time of procedure
Side effects	5 minutes after the procedure	Reported side effects

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Napoli, Italy