NCT05069064

Brief Summary

The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.

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
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

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
10 days until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

September 25, 2021

Last Update Submit

September 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain During contrast medium injection

    pain will be assessed by visual analog scale from 0 to 10

    5 minutes

Secondary Outcomes (1)

  • pain after hysterosalpingography

    10 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 hysterosalpingography 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 headphone in order to maintain a good communication and interaction between the participant and the doctor.

music group

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

Age19 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertility; patients aged 19 to 42 years; candidate for hysterosalpingography.

You may not qualify if:

  • Severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.

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

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 5, 2021

Primary Completion

June 1, 2022

Study Completion

June 15, 2022

Last Updated

October 6, 2021

Record last verified: 2021-09