The effect of white noise and Benson relaxation technique on death anxiety in patients undergoing coronary artery bypass graft surgery at Farshchian Hospital in Hamadan in 2021
Determining the effect of white noise and Benson relaxation technique on death anxiety in patients undergoing coronary artery bypass graft surgery.
Design
The present study is a randomized two-group clinical trial study to investigate the effect of white noise and Benson relaxation technique on the anxiety of death of 60 patients undergoing open heart surgery admitted to Farshchian cardiovascular hospital in Hamadan in 1400.The research units will be selected by available sampling method and will be randomly divided into control and test groups.
Settings and conduct
This study will be conducted with the participation of 60 patients in Farshchian Hospital in Hamadan in 1400. Patients will be randomly divided into control and test groups. In the intervention group, the patient is asked to listen to music in the morning, afternoon, and evening for 30 minutes while performing Benson's relaxation technique. In the control group, only routine care will be done. After the intervention, the questionnaire will be completed by two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction of patients to participate in the research, Not participating in similar Benson relaxation courses, Absence of musculoskeletal disorder.
Exclusion criteria: Patient's unwillingness to participate in the study, Instability of the hemodynamic status
Intervention groups
Intervention group: Intervention group: Benson relaxation technique with white music will be taught to the experimental group by the researcher. The patient will be asked to listen to music while performing Benson's relaxation technique. At the end of the intervention, the Templer death anxiety questionnaire will be completed by the experimental and control groups.
Control group: In the control group, only routine care will be performed.
Main outcome variables
Death anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N35
Registration date:2021-05-15, 1400/02/25
Registration timing:prospective
Last update:2021-05-15, 1400/02/25
Update count:0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of white noise and Benson relaxation technique on death anxiety in patients undergoing coronary artery bypass graft surgery at Farshchian Hospital in Hamadan in 2021
Public title
Effect of white noise and Benson relaxation technique on death anxiety in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the person to participate in the research
Not participating in similar Benson relaxation courses
Absence of musculoskeletal disorders
Exclusion criteria:
Instability of the patient's hemodynamic status
Age
From 40 years old to 75 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 the present study, the patients were registered according to the sample size (60) and according to the inclusion criteria, and using the blocking method (using a two-block method, two letters A and B with different permutations we place in blocks and randomly select 30 blocks and assign each block to 2 people) will be assigned to two groups
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
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2020-12-10, 1399/09/20
Ethics committee reference number
IR.UMSHA.REC.1399.881
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.11
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with angina pectoris
Primary outcomes
1
Description
Death anxiety
Timepoint
Before and two weeks after the intervention
Method of measurement
Templer death anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the patient will be asked to listen to music in the morning, afternoon, and evening for 30 minutes while performing Benson's relaxation technique.
Category
N/A
2
Description
Control group: In the control group, only routine care will be provided.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Shadi Dalvand
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Shadi Dalvand
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
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