Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy

NCT ID: NCT05700123

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2025-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Video

Group Type EXPERIMENTAL

In-Office Hysteroscopy

Intervention Type PROCEDURE

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

Music

Group Type EXPERIMENTAL

In-Office Hysteroscopy

Intervention Type PROCEDURE

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

Vocal-Local

Group Type ACTIVE_COMPARATOR

In-Office Hysteroscopy

Intervention Type PROCEDURE

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

Interventions

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In-Office Hysteroscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Denied consent
* Use of analgesic drugs before the procedure
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Riemma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pasquale Franciscis, MD PhD

Role: STUDY_CHAIR

Università della Campania Luigi Vanvitelli

Gaetano Riemma

Role: PRINCIPAL_INVESTIGATOR

Università della Campania Luigi Vanvitelli

Locations

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University of Bari

Bari, , Italy

Site Status

University of Cagliari

Cagliari, , Italy

Site Status

University of Campania "Luigi Vanvitelli"

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0013700/i

Identifier Type: -

Identifier Source: org_study_id

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