Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
1 other identifier
interventional
130
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedStudy Start
First participant enrolled
October 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedOctober 6, 2021
September 1, 2021
6 months
September 25, 2021
September 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Intensity of pain
30 minutes
women satisfaction
30 minutes
Study Arms (2)
music group
EXPERIMENTALIn 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.
non-music group
OTHERParticipants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
Interventions
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.
Eligibility Criteria
You may qualify if:
- women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Hospital El Gezeeracollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor of obstetrics and gynecology
Study Record Dates
First Submitted
September 25, 2021
First Posted
October 6, 2021
Study Start
October 10, 2021
Primary Completion
April 10, 2022
Study Completion
April 30, 2022
Last Updated
October 6, 2021
Record last verified: 2021-09