NCT05069077

Brief Summary

The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

September 25, 2021

Last Update Submit

January 15, 2025

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 100

    5 minutes

Secondary Outcomes (1)

  • Intensity of pain

    20 minutes

Study Arms (2)

music group

EXPERIMENTAL

In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.

Other: Music

non-music group

OTHER

Participants in the non-music group will undergo diagnostic outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Other: No music

Interventions

MusicOTHER

In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.

music group
No musicOTHER

Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

non-music group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

You may not qualify if:

  • patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities
0

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 of obstetrics and gynecology

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 6, 2021

Study Start

October 15, 2021

Primary Completion

May 10, 2022

Study Completion

May 15, 2022

Last Updated

January 17, 2025

Record last verified: 2025-01