Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography

Effect of Music on Pain and Satisfaction in Infertile Patients Undergoing Hysterosalpingography: a Randomized Controlled Trial

The aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 108
• 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: 19 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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 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.
Other: non-music group; Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.	Other: no music; Participants in the non-music group will undergo hysterosalpingography 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
pain During contrast medium injection	pain will be assessed by visual analog scale from 0 to 10	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain after hysterosalpingography	pain will be assessed by visual analog scale from 0 to 10	10 minutes

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Hospital El Gezeera

Study record dates

Study Major Dates

• Study Start (Anticipated): October 5, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 15, 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: hysterosalpingography music

Drug and device information, study documents

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