Back to resultsUse of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
Primary Purpose
Hysteroscopy
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 Hysteroscopy
Eligibility Criteria
Inclusion Criteria:
- women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Exclusion Criteria:
- women with suspected pregnancy
heavy vaginal bleeding recent pelvic infection those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
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 outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
Outcomes
Primary Outcome Measures
Intensity of pain
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Secondary Outcome Measures
Intensity of pain
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
women satisfaction
satisfaction will be assessed by visual analogue scale-like scale ranging from 0 to 10 (0=no satisfaction; 10=maximal satisfaction)
Full Information
NCT ID
NCT05069025
First Posted
September 25, 2021
Last Updated
September 25, 2021
Sponsor
Cairo University
Collaborators
Hospital El Gezeera
1. Study Identification
Unique Protocol Identification Number
NCT05069025
Brief Title
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
Official Title
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients: Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2021 (Anticipated)
Primary Completion Date
April 10, 2022 (Anticipated)
Study Completion Date
April 30, 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 outpatient hysteroscopy on patients' level of pain and satisfaction in primarily infertile patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (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 outpatient hysteroscopy 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 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.
Intervention Type
Other
Intervention Name(s)
no-music
Intervention Description
Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Intensity of pain
Description
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Time Frame
30 minutes
Title
women satisfaction
Description
satisfaction will be assessed by visual analogue scale-like scale ranging from 0 to 10 (0=no satisfaction; 10=maximal satisfaction)
Time Frame
30 minutes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Exclusion Criteria:
women with suspected pregnancy
heavy vaginal bleeding recent pelvic infection those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
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
Plan to Share IPD
Undecided
Learn more about this trial
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
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