Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients

Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients: Prospective Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hysteroscopy
• Intervention / Treatment: Other: music; Other: no-music

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AHMED SAMY; Phone Number: 01100681167; Email: ahmedsamy8233@gmail.com
• Study Contact Backup: Name: ahmed s ali; Phone Number: 01558869998; Email: ahmedsaidali987@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: music group; 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.	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.
Other: non-music group; Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.	Other: no-music; Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Hospital El Gezeera

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2021
• Primary Completion (Anticipated): April 10, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: a8233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No