Virtual Reality's Role in See&Treat Hysteroscopy

The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Hyperplasia; Endometrial Cancer; Myoma;Uterus; Endometrial Diseases
• Intervention / Treatment: Device: Use of virtual reality during the hysteroscopic procedure

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 810131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; The patients in this group undergo the procedure using virtual reality.	Device: Use of virtual reality during the hysteroscopic procedure; In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.
No Intervention: Control group; The patients in this group undergo the procedure without the use of virtual reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Brunella Ms Zizolfi, AssProfessor, University Federico II of Naples - Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): July 6, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality Technology; Outpatient Hysteroscopy; Pain and Anxiety Management; See & Treat
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms; Uterine Diseases; Leiomyoma; Myofibroma
• Other Study ID Numbers: 112/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No