NCT06524934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 18, 2024

Last Update Submit

July 24, 2024

Conditions

Endometrial CancerEndometrial DiseasesMyoma;UterusEndometrial Hyperplasia

Keywords

Outpatient HysteroscopyVirtual Reality TechnologyPain and Anxiety ManagementSee & Treat

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (4)

  • Suspension rate of procedure

    During procedure

  • Time of procedure

    During procedure

  • Satisfaction rate

    5 minutes after the procedure

  • Side effects

    5 minutes after the procedure

Study Arms (2)

Case group

EXPERIMENTAL

The patients in this group undergo the procedure using virtual reality.

Device: Use of virtual reality during the hysteroscopic procedure

Control group

NO INTERVENTION

The patients in this group undergo the procedure without the use of virtual reality.

Interventions

Use of virtual reality during the hysteroscopic procedureDEVICE

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.

Case group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Napoli, 810131, Italy

Location

MeSH Terms

Conditions

Endometrial NeoplasmsUterine DiseasesMyofibromaEndometrial HyperplasiaPain

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brunella Ms Zizolfi, AssProfessor

    University Federico II of Naples - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 29, 2024

Study Start

May 16, 2024

Primary Completion

July 6, 2024

Study Completion

July 15, 2024

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

IT(1)