Determining the effect of nature-based sounds on anxiety and stress and physiological variables of myocardial infarction patients
Design
Clinical trial with control and intervention group and randomized
Settings and conduct
Patients with myocardial infarction diagnosed by a physician admitted to ccu wards in Golestan and Imam hospitals of Ahvaz will be randomly divided into two groups of intervention and control after obtaining written and informed consent.
Participants/Inclusion and exclusion criteria
_heart attack
- Not being fully conscious and not intubating
- Not being in a critical condition in terms of health
- No smoking
- No respiratory and mental illnesses known and diagnosed by a doctor
- Literacy
Intervention groups
Heart attack patients admitted to the hospital after obtaining informed written consent, enter the study. In this method, an MP3 device that contains different sounds based on nature is given to patients in the intervention group and they are asked to during the day and especially in In times of stress, listen to their favorite natural sounds.This will be done for three days. And every day the researcher is present in the department and the questionnaires and vital signs are completed before and after listening to the music. Nature sounds are played using an MP3 device using headphonesQuestionnaires and vital signs will be completed by participants before the intervention and every day for three days. All patients in the control group receive routine care
The effect of nature-based sounds on anxiety, stress and physiologic variables of myocardial infarction patients
Public title
The effect of nature-based sounds on anxiety, stress and physiological variables of myocardial infarction patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
heart attack
Complete consciousness and lack of intuition
Not being in a critical health condition
No smoking
No drug addiction
Be literate
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
.After selecting myocardial infarction patients hospitalized in the ccu ward, patients are divided into two groups of intervention and control by simple randomization using lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University
Street address
Golestan, Esfand Street
City
Ahvaz
Province
Khouzestan
Postal code
6391995855
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
Iranums.rec.1398-752
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
Primary outcomes
1
Description
Stress
Timepoint
Measuring stress and anxiety and physiological variables during three consecutive days before and after listening to music
Method of measurement
DOS Questionnaire - Spielberger Questionnaire - Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Listen to nature-based music
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan and Imam Ahvaz Hospital
Full name of responsible person
Shekoufe fatehi moghadam
Street address
Golestan, Esfand St., Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6391995855
Phone
+98 61 4362 7805
Email
Shekoufefatehi2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shekoufe fatehi moghadam
Street address
Golestan, Esfand St., Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6391995855
Phone
+98 61 4362 7805
Email
Shekoufefatehi2013@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
40
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
Ahvaz University of Medical Sciences
Full name of responsible person
Shekoufe fatehi moghadam
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Golestan, Esfand St., Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6391995855
Phone
+98 61 4362 7805
Email
Shekoufefatehi2013@gmail
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shekoufe fatehi moghadam
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Golestan, Esfand St., Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6391995855
Phone
+98 61 4362 7805
Email
Shekoufefatehi2013@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shekoufe fatehi moghadam
Position
Student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Golestan, Esfand St., Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
63919o5855
Phone
+98 61 4362 7805
Email
Shekoufefatehi2013@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