Determining the effect of binaural sound waves on fatigue and quality of life of hemodialysis patients
Design
Human interventional study (before and after trial), on 74 patients, with random block allocation with replacement
Settings and conduct
74 patients undergoing hemodialysis in hemodialysis centers affiliated to Yasuj University of Medical Sciences, will be selected by the available method and assigned to two intervention and control groups by random block allocation with replacement. In the intervention group, for two months, during the final hours of hemodialysis, two to three times a week and for 30 minutes, binaural beats are broadcast to the patients through hands-free by the researcher, and the patients are also asked on other days they do not come for hemodialysis, to listen to these waves during the day (noon) and at night before going to sleep. Binaural beats are captured through Audacity software and the audio file of these waves will be provided to the patients, the frequency of which is 10 Hz (right ear: 200 Hz, left ear: 210 Hz). Patients are allowed to adjust the volume to their liking. People in the control group will receive their usual care
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1)healthy listening condition and ability to hear voices 2)age over 18 years 3)history of hemodialysis for at least 3 months 4)moderate to high fatigue (fatigue score of 4 and above)
Exclusion criteria: 1)unwillingness to participate in the study 2)age less than 18 years 3)low fatigue (fatigue score of 3 and below) 4)use of hearing aids
Intervention groups
In the intervention group, patients will listen to binaural beats for two months. People in the control group will receive their usual care
Main outcome variables
Fatigue, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240713062415N1
Registration date:2024-07-20, 1403/04/30
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 0750
Email address
mohammadmohammadinurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of binaural beats on fatigue and quality of life of patients undergoing hemodialysis
Public title
The effect of binaural beats on fatigue and quality of life in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy hearing condition and ability to hear sounds
Age above 18 years
History of hemodialysis for at least 3 months
At least two dialysis sessions per week
Moderate to high fatigue (fatigue score of 4 and above)
Exclusion criteria:
Unwillingness to participate in the study
Age less than 18 years
Inability to perform the intervention protocol
History of substance abuse
Low fatigue (fatigue score of 3 or less)
Use of hearing aids
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used, considering the presence of 2 control and intervention groups, blocks of size 2 were considered, and two combinations of AB and BA were considered as all possible modes of allocation of patients in each block. The randomization unit is each person who will be independently and randomly assigned to one of the two intervention or control groups. For randomization, a lottery tool will be used. First, the labeling of the groups was determined using a lottery that A = control and B = intervention. The way to make a random sequence is that according to the total number of 74 patients, using a lottery with repositioning, 37 random sequences of AB and BA combinations will be produced, meaning that for each block, one of the two combinations AB or BA will be randomly selected and this process will be repeated 37 times to determine the allocation order for a total of 74 patients. The way people enter the randomly generated chain will be in such a way that after selecting the patients using the available method and confirming eligibility based on the inclusion and exclusion criteria, each patient will be assigned to the control or intervention group based on the selected combination. After allocating two patients in order and based on the composition of the current block, it will go to the next block and this work will continue until the allocation of 74 patients. blinding will only be done for the data analyst and the data will be presented to him in a coded form.
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
Yasuj University of Medical Sciences Research Ethics Committee
Street address
Shahid Motahari Blvd. - Headquarters of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.YUMS.REC.1403.033
Health conditions studied
1
Description of health condition studied
Patients undergoing hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fatigue
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 2 months after the start of the intervention
Method of measurement
Piper Fatigue Scale
2
Description
Quality of life
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 2 months after the start of the intervention
Method of measurement
Kidney Disease Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For two months, during the final hours of hemodialysis, two to three times a week and for 30 minutes, binaural beats will broadcast to patients through hands-free by the researcher, and the patients are also asked on other days when they do not come for hemodialysis to Listen to these waves at noon and at night before going to sleep. Binaural beats are captured through Audacity software and the binaural sound file will be provided to patients. The frequency of binaural beats is 10 Hz (right ear: 200 Hz, left ear: 210 Hz)
Category
Treatment - Other
2
Description
Control group: During this period, there will be no intervention on the control group and they will only receive their usual care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Department of Shahid Jalil Hospital
Full name of responsible person
Dr. Rozina Abbasi Larki
Street address
Qarani Boulevard, Shahid Jalil Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
Larki1353@gmail.com
2
Recruitment center
Name of recruitment center
Hemodialysis Department of Shahid Beheshti Hospital
Full name of responsible person
Dr. Rozina Abbasi Larki
Street address
Shahid Mohammad Montazeri Street, Shahid Beheshti Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
Larki1353@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hosseini Motlagh
Street address
Shahid Motahari Blvd, Yasuj University of Medical Sciences, Research Vice-Chancellor
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Data relevant to the study's main outcomes will be published
When the data will become available and for how long
Available after results are published
To whom data/document is available
Only members of the research team based on the principles specified in the research and patients will be allowed access to their information at the specified level. Other researchers and individuals will have access to the analyzed information without mentioning the details
Under which criteria data/document could be used
In order to conduct research on qualified people and also for the transparency of the study process
Also statistical analysis is allowed
From where data/document is obtainable
To receive documents, send a message to mohammadmohammadinurse@gmail.com
What processes are involved for a request to access data/document
Access to the documents is after obtaining permission from the Research Vice-Chancellor of Yasuj University of Medical Sciences and with the coordination of the main researcher of the research