Comparison of the Effect of Music Therapy and Guided Imagination on Anxiety in Patients Before Coronary Artery Bypass Grafting in Heshmat Hospital in Rasht;
Design
Clinical trial with control group, with parallel groups, one blinded, randomized
Settings and conduct
For patients before coronary artery bypass grafting hospitalized in surgery wards of heshmat hospital in rasht ,7 days prior to cardiac surgery will be listened to bach nonverbal music CD and guided imagery CD for 7 session during 18-20 mintutes.7 days before CABG and immediately at the end of listening to CDs, the apparent and hidden anxiety scores of the subjects under study will be measured by the Spielberger questionnaire. The present study design is one blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1) having an age of 20-65 years; 2) having a minimum reading and writing literacy; 3) not having hearing impairment; 4) lack of addiction to alcohol and drugs; 5) having undergone cardiac surgery for the first time;
Non-compliance criteria:
1) the patient's dissatisfaction with the continuation of the study, 2) receiving sedation drugs within the last 24 hours, 3) having arrhythmias (Atrial fibrillation, etc.), 4) lack of experience in the use of relaxation and guided imagery classes and music therapy 5) having a degree in psychology and related fields; 6) having a bitter memory of the sea;
Intervention groups
Eligible individuals are randomly assigned to the 3 groups according to block randomized allocation.The first group, the group that is undergoing music therapy;The second group, the group being guided imagery and the third group, a group that receives routin nursing care without interventions.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N3
Registration date:2019-06-11, 1398/03/21
Registration timing:registered_while_recruiting
Last update:2019-06-11, 1398/03/21
Update count:0
Registration date
2019-06-11, 1398/03/21
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-07-09, 1398/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of Guided Imagery and music therapy on Anxiety in patients before Coronary Artery Bypass Grafting
Public title
The Effect of Music Therapy and Guided Imaging on Anxiety in Coronary Artery Bypass Grafting patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the age of 20-65 years
2) having the least reading and writing skills
3) not having hearing impairment
4) lack of drug and alcohol addiction
5) undergoing cardiac surgery for the first time
6) having anxiety Less than 64 on anxiety scale and anxiety less than 62 in the hidden anxiety scale;
Exclusion criteria:
Patient's dissatisfaction with the continuation of the study
2) Receiving sedation drugs within 24 hours ago
3) Having dangerous arrhythmias (atrial fibrillation, etc
4) No history of using relaxation and guided visualization classes and music therapy
5) Having a degree in psychology and related courses
6) having a bitter memory of the sea
7) any pain and calmness or calmness habit
8) a history of participation in training courses on stress and yoga control at the previous 6 months
9 ) The history of a new crisis, such as the death of a first-degree relative, a self-divorce or his/her parent`s at the previous 6 months
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are randomly assigned to the 3 groups according to block randomized allocation.Random sequences will be generated using the Random Generator program. Based on the random block method and considering the six blocks, 14 blocks will be generated for 84 patients. To hide the randomization process from sealed envelopes, which are numbered sequentially will be used and the envelope related to each person will be opened only after the verification of the inclusion criteria eligible and sign in the consent form.
Blinding (investigator's opinion)
Single blinded
Blinding description
Registration and sequencing of random allocation is done by the collaborator of the methodology of the project and the assignment of interventions by the collaborator of the project, which is blinded to the control and intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Rasht, Namjoo Ave., Shahid Siadati St., Faced to the 17th Shahrivar Hospital, Old Building, School of Health, University of Technology Research and Technology
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.GUMS.REC.1398.084
Health conditions studied
1
Description of health condition studied
Patients before cardiac bypass surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Anxiety
Timepoint
7 days before the operation and immediately at the end of listening to Bach nonverbal music CD and guided imagery CD auditory
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 7days prior to cardiac surgery will be listened to Bach nonverbal music CD for 7 sessions during 18-20 mintutes.
Category
Other
2
Description
Intervention group:7days prior to cardiac surgery will be listened to guided imagery CD for 7 sessions during 18-20 mintutes.
Category
Other
3
Description
Control group: A group that receives routin nursing care without intervention and just get training during treatment by nurse .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Rasht Hospital
Full name of responsible person
Zahra Ahmadnia
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Fax
+98 31 3361 8177
Email
Zahmadnia@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Namjoo Ave., Shahid Siadati St., Rasht., Technology & Research Vice-chancellor of University
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 31 3333 2058
Fax
+98 31 3333 2058
Email
Zahmadnia@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
Zahmadnia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
Zahmadnia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
Zahmadnia@gums.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