ViMAP-OH: Videos and Music for Reducing Anxiety and Pain During In-office Hysteroscopy

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Recruiting

CT.gov ID

NCT05700123

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: In-Office Hysteroscopy

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Usefulness of Videos and Music for Reducing Anxiety and Pain During In-office Hysteroscopy

Actual Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Video	Procedure: In-Office Hysteroscopy In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach
Music	Procedure: In-Office Hysteroscopy In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach
Vocal-Local	Procedure: In-Office Hysteroscopy In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach

Arm

Intervention/Treatment

Video

Procedure: In-Office Hysteroscopy

In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach

Music

Procedure: In-Office Hysteroscopy

In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach

Vocal-Local

Procedure: In-Office Hysteroscopy

In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach

Outcome Measures

Primary Outcome Measures

The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries [24 hours]
20 (better) - 80 (worse)
post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS) [24 hours]
1 (better) - 10 (worse)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

Premenopausal and postmenopausal women
Indication for in-office operative hysteroscopy

Exclusion Criteria:

Denied consent
Use of analgesic drugs before the procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Campania "Luigi Vanvitelli"	Napoli		Italy	80138

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

Study Chair: Pasquale Franciscis, MD PhD, Università della Campania Luigi Vanvitelli
Principal Investigator: Gaetano Riemma, Università della Campania Luigi Vanvitelli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Riemma, Co-Principal Investigator, University of Campania "Luigi Vanvitelli"

ClinicalTrials.gov Identifier:

NCT05700123

Other Study ID Numbers:

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jan 26, 2023