Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05069064

Collaborator

Al Gezeera Hospital (Other)

108

Enrollment

Arms

8.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hysterosalpingography	Other: music Other: no music	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial

Anticipated Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: music group 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 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.
Other: non-music group Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.	Other: no music Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.

Arm

Intervention/Treatment

Experimental: music group

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

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.

Other: non-music group

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

Other: no music

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

Outcome Measures

Primary Outcome Measures

pain During contrast medium injection [5 minutes]
pain will be assessed by visual analog scale from 0 to 10

Secondary Outcome Measures

pain after hysterosalpingography [10 minutes]
pain will be assessed by visual analog scale from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University
Al Gezeera Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Samy aly ashour, assistant professor of obstetrics and gynecology, Cairo University

ClinicalTrials.gov Identifier:

NCT05069064

Other Study ID Numbers:

hysterosalpingography music

First Posted:

Oct 6, 2021

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Oct 6, 2021