Effect of white noise versus control group on the pain and anxiety of patients undergoing extracorporeal shock wave lithotripsy: a randomized clinical trial
To assess the effect of white noise versus control group on the pain and anxiety of patients during extracorporeal shock wave lithotripsy
Design
This is a randomized clinical trial study with a control group, with parallel design, without the possibility of blinding, phase 3, in which 60 eligible patients will be randomly assigned to two intervention and control groups by lottery method.
Settings and conduct
This study will be conducted at the Beheshti Hospital in Hamadan city, involving 60 eligible patients undergoing extracorporeal shock wave lithotripsy. The patients will be randomly assigned in parallel design to the intervention and control groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 50 years
Indications for extracorporeal shock wave lithotripsy
Being literate
Exclusion criteria:
Having colicky kidney pains before lithotripsy
Auditory disorder
History of anxiety or mental disorder
Intervention groups
Intervention group:
Routine care during extracorporeal shock wave lithotripsy in addition to playing white noise (including the sound of nature such as the sound of birds and the sound of water) with a frequency lower than 85 dB for 45 minutes through headphones
Control group:
Just routine care during extracorporeal shock wave lithotripsy
Main outcome variables
Pain score; anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N497
Registration date:2024-02-14, 1402/11/25
Registration timing:prospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
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
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of white noise versus control group on the pain and anxiety of patients undergoing extracorporeal shock wave lithotripsy: a randomized clinical trial
Public title
Effect of white noise versus control group on the pain and anxiety of patients undergoing extracorporeal shock wave lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 50 years
Indications for extracorporeal shock wave lithotripsy
Being literate
Exclusion criteria:
Having colicky kidney pains before lithotripsy
Auditory disorder
History of anxiety or mental disorder
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
IR.UMSHA.REC.1402.687
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
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain score
Timepoint
Before the intervention and immediately after that
Method of measurement
using the Visual Analog Scale (VAS)
2
Description
Anxiety score
Timepoint
Before the intervention and immediately after that
Method of measurement
Using the Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during extracorporeal shock wave lithotripsy in addition to playing white noise (including the sound of nature such as the sound of birds and the sound of water) with a frequency lower than 85 dB for 45 minutes through headphones
Category
Treatment - Devices
2
Description
Control group: Just routine care during extracorporeal shock wave lithotripsy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Zahra Karimi Vafa
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
zahrakarimivafa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Karimi Vafa
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrakarimivafa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Arezoo Karampoorian
Position
Health in Emergency and Disasters Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
karampor1@yahoo.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