Back to resultsEffect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography
Primary Purpose
Hysterosalpingography
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
music
no music
Sponsored by
About this trial
This is an interventional supportive care trial for Hysterosalpingography
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
music group
non-music group
Arm Description
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.
Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.
Outcomes
Primary Outcome Measures
pain During contrast medium injection
pain will be assessed by visual analog scale from 0 to 10
Secondary Outcome Measures
pain after hysterosalpingography
pain will be assessed by visual analog scale from 0 to 10
Full Information
NCT ID
NCT05069064
First Posted
September 25, 2021
Last Updated
September 25, 2021
Sponsor
Cairo University
Collaborators
Hospital El Gezeera
1. Study Identification
Unique Protocol Identification Number
NCT05069064
Brief Title
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography
Official Title
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Hospital El Gezeera
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterosalpingography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
music group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-music group
Arm Type
Other
Arm Description
Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no music
Intervention Description
Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.
Primary Outcome Measure Information:
Title
pain During contrast medium injection
Description
pain will be assessed by visual analog scale from 0 to 10
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
pain after hysterosalpingography
Description
pain will be assessed by visual analog scale from 0 to 10
Time Frame
10 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHMED SAMY
Phone
01100681167
Email
ahmedsamy8233@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed s ali
Phone
01558869998
Email
ahmedsaidali987@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography
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