NCT06767644

Brief Summary

This study aims to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and anxiety in postmenopausal women

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 4, 2025

Last Update Submit

January 4, 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 10

    5 minutes

Secondary Outcomes (1)

  • anxiety during procedure

    5 minutes

Study Arms (2)

music group

EXPERIMENTAL
Other: music

non-music group

PLACEBO COMPARATOR
Other: no music

Interventions

musicOTHER

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.

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

Central Study Contacts

AHMED ALI

CONTACT

01100681167ahmedsamy8233@gmail.com

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
professor

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 10, 2025

Study Start

February 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 30, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01