NCT06772636

Brief Summary

This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

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
110

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable pain

Status
not yet recruiting

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

January 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

Pain

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 where 0 denotes no pain and 10 denotes maximum pain felt

    10 minutes

Secondary Outcomes (1)

  • anxiety during procedure

    10 minutes

Study Arms (2)

music group

EXPERIMENTAL
Procedure: music group

non-music group

OTHER
Procedure: non music group

Interventions

music groupPROCEDURE

In the music group, the 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
non music groupPROCEDURE

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

non-music group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

You may not qualify if:

  • Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, Current pregnancy or suspicion of pregnancy.Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

AHMED SAMY ALI ASHOUR, MD

CONTACT

01100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 13, 2025

Study Start

March 1, 2025

Primary Completion

August 10, 2025

Study Completion

August 20, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01