Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (ViMAP-OH)

January 11, 2025 updated by: Gaetano Riemma, University of Campania Luigi Vanvitelli

Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (Metodiche Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • University of Bari
      • Cagliari, Italy
        • University of Cagliari
      • Napoli, Italy, 80138
        • University of Campania "Luigi Vanvitelli"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Women scheduled for in-office hysteroscopy due to common clinical indications (i.e. abnormal uterine bleeding, infertility)

Description

Inclusion Criteria:

  • Premenopausal and postmenopausal women
  • Indication for in-office operative hysteroscopy

Exclusion Criteria:

  • Denied consent
  • Use of analgesic drugs before the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0013700/i

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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