NCT05700123

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

January 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 13, 2023

Last Update Submit

January 11, 2025

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

  • The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries

    20 (better) - 80 (worse)

    24 hours

  • post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)

    1 (better) - 10 (worse)

    24 hours

Study Arms (3)

Video

EXPERIMENTAL
Procedure: In-Office Hysteroscopy

Music

EXPERIMENTAL
Procedure: In-Office Hysteroscopy

Vocal-Local

ACTIVE COMPARATOR
Procedure: In-Office Hysteroscopy

Interventions

In-Office HysteroscopyPROCEDURE

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

MusicVideoVocal-Local

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Denied consent
  • Use of analgesic drugs before the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Bari

Bari, Italy

Location

University of Cagliari

Cagliari, Italy

Location

University of Campania "Luigi Vanvitelli"

Napoli, 80138, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Pasquale Franciscis, MD PhD

    Università della Campania Luigi Vanvitelli

    STUDY CHAIR

  • Gaetano Riemma

    Università della Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 26, 2023

Study Start

May 9, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)