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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05069025
Other study ID # a8233
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date April 30, 2022

Study information

Verified date September 2021
Source Cairo University
Contact AHMED SAMY
Phone 01100681167
Email ahmedsamy8233@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date April 30, 2022
Est. primary completion date April 10, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
music
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.
no-music
Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Cairo University Al Gezeera Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of pain Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10 5 minutes
Secondary 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 30 minutes
Secondary women satisfaction satisfaction will be assessed by visual analogue scale-like scale ranging from 0 to 10 (0=no satisfaction; 10=maximal satisfaction) 30 minutes
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