Effect of allowed favorite music versus control group on the pain and anxiety of patients under extracorporeal shock wave lithotripsy: a randomized control trial
To assess the effect of allowed favorite music versus control group on the pain and anxiety of patients under extracorporeal shock wave lithotripsy
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 60 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Alborz Hospital in Karaj city, involving 60 eligible patients under extracorporeal shock wave lithotripsy. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Kidney stones
Healthy hearing
Literacy
Ability to speak Persian
Exclusion criteria:
Renal colic pain before lithotripsy
Previous history of lithotripsy
Use of anti-anxiety drugs, narcotics, painkillers
Neurological and psychiatric diseases
Intervention groups
Intervention group:
Routine care before extracorporeal lithotripsy plus playing favorite music (including classical, pop, etc.) using Tesco Bluetooth headphones, model TH-5376, with a frequency of less than 85 dB for 15 to 30 minutes before extracorporeal lithotripsy
Control group:
Only routine care before extracorporeal lithotripsy
Main outcome variables
Primary outcome:
Pain intensity; Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N567
Registration date:2025-08-04, 1404/05/13
Registration timing:prospective
Last update:2025-08-04, 1404/05/13
Update count:0
Registration date
2025-08-04, 1404/05/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of allowed favorite music versus control group on the pain and anxiety of patients under extracorporeal shock wave lithotripsy: a randomized control trial
Public title
Effect of allowed favorite music versus control group on the pain and anxiety of patients under extracorporeal shock wave lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Kidney stones
Healthy hearing
Literacy
Ability to speak Persian
Exclusion criteria:
Renal colic pain before lithotripsy
Previous history of lithotripsy
Use of anti-anxiety drugs, narcotics, painkillers
Neurological and psychiatric diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Asadabad School of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Asadabad School of Medical Sciences, Rafsanjani Ave.
City
Asadabad
Province
Hamadan
Postal code
6541843189
Approval date
2025-07-02, 1404/04/11
Ethics committee reference number
IR.ASAUMS.REC.1404.003
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Renal colic pain
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain intensity
Timepoint
Before the start of lithotripsy and immediately after the end of lithotripsy
Method of measurement
Using the Visual Analog Scale (VAS)
2
Description
Anxiety score
Timepoint
Before the start of lithotripsy and immediately after the end of lithotripsy
Method of measurement
Using the Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care before extracorporeal lithotripsy plus playing favorite music (including classical, pop, etc.) using Tesco Bluetooth headphones, model TH-5376, with a frequency of less than 85 dB for 15 to 30 minutes before extracorporeal lithotripsy
Category
Treatment - Other
2
Description
Control group: Only routine care before extracorporeal lithotripsy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Hospital in Karaj city
Full name of responsible person
Daniel Moradi
Street address
Alborz Hospital, Parastar Ave.
City
Karaj
Province
Alborz
Postal code
6541843189
Phone
+98 81 3313 2015
Email
daniel.moradi7678@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
Sasan Navkhasi
Street address
Vice-chancellor for Research and Technology, Asadabad School of Medical Sciences, Rafsanjani Ave.
City
Asadabad
Province
Hamadan
Postal code
6541843189
Phone
+98 81 3313 2015
Email
n.heydari@asaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Asadabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
Daniel Moradi
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Asadabad School of Medical Sciences, Rafsanjani Ave.
City
Asadabad
Province
Hamadan
Postal code
6541843189
Phone
+98 81 3313 2015
Email
daniel.moradi7678@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
Daniel Moradi
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Asadabad School of Medical Sciences, Rafsanjani Ave.
City
Asadabad
Province
Hamadan
Postal code
6541843189
Phone
+98 81 3313 2015
Email
daniel.moradi7678@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available