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Effect 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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hysterosalpingography

Eligibility Criteria

19 Years - 42 Years (Adult)FemaleDoes not accept 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.

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

    First Posted
    September 25, 2021
    Last Updated
    September 25, 2021
    Sponsor
    Cairo University
    Collaborators
    Hospital El Gezeera
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    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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