Determining the effect of Benson relaxation method on anxiety of patients with myocardial infarction, hospitalized in CCU wards.
Design
Comparison of Benson relaxation technique with routine treatment method in patient with myocardial infarction admitted to Urmia Seyyed Shohada Hospital who were non-randomly allocated to intervention and control groups with parallel-group design. Non of these groups were blind. The sample size was 60.
Settings and conduct
Every admitted patient with myocardial infarction in intensive care unit of Urmia Seyyedol Shohada Hospital was identified by the researcher and non-randomly was allocated to one of the groups. After obtaining consent and stabilizing the patient's condition and also the approval of the physician, a pre-test based on the demographic form and the Spielberger questionnaire was performed. In control group there was no intervention. These patients were put under the routine care only. In intervention group, pretest was done after explaining about the steps on the first day. In this group, Benson relaxation was performed for each patient, two 15-minute sessions a day for 2 consecutive days. Post-test was done on second.
Participants/Inclusion and exclusion criteria
Inclusion criteria: heart attack based on doctor's approval; Complete patient awareness; hospitalization; No history of mental illness; absence of work experience in health centers; absence of relaxation methods; Willingness to cooperate
Non-inclusion criteria: History of anti-anxiety drugs; consciousness level change; Complications of disease; non cooperation or death of the patient; Cardiopulmonary resuscitation.
Intervention groups
In the intervention group, Benson's relaxation was performed during 2 days and in the morning and evening, and the control group received routine care only.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160220026662N6
Registration date:2019-01-07, 1397/10/17
Registration timing:retrospective
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4816
Email address
nader1453@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-20, 1396/02/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2017-06-02, 1396/03/12
Actual recruitment end date
2017-09-01, 1396/06/10
Trial completion date
2017-09-01, 1396/06/10
Scientific title
Comparison of the effect of Benson relaxation method and routine treatment on anxiety in patients with myocardial infarction.
Public title
The effect of Benson relaxation method on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a heart attack approved by a medical practitioner
Complete patient consciousness
hospitalization in the ward
No history of mental illness
Not having work experience in the health centers
Not receiving relaxation methods
Willingness to cooperate
Exclusion criteria:
History of consuming anti-anxiety drugs
Changing the level of consciousness
Occurrence of disease complications
Lack of cooperation or death of the patient
Cardio-pulmonary resuscitation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
IR.UMSU.IRC.1396.31
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
َAnxiety
Timepoint
Before the intervention and after the end of the intervention on the second day
Method of measurement
The Spielberger state-trait anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Benson's relaxation technique for each patient for 2 consecutive days and 2 times a day in the morning and at night between 10-11 am and 6-5 pm, and each times for 15 minutes (4 sessions ) was performed. On the second day after the implementation of the fourth session of the relaxation technique, the Spielberger Anxiety Scale Questionnaire for the intervention group was completed. This technique for patients in the intervention group in the intensive care unit on the patient's bed was placed in a semi-sitting position (45 degrees) was performed. As much as possible, light above the head of the patient and monitor's voice are reduced and, if the patient is beaten up, the alarms of the devices are used by the headphones or by any means in the ear to prevent disturbing sounds. Then it was asked from the patient to perform the Benson's relaxation as follows: the patient should be in a comfortable position and slowly close his eyes while relaxing his muscles from the soles of feets, he consciously breathes out of his nose and exhales out of his mouth while murmuring a word or a number that make him calm after repeating this task for 15 minutes, he should try to relax his muscles. Then he can open his eyes, however, for a few minutes he should not get up.
Category
Other
2
Description
Control group: No intervention was done in the control group and this group only received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedolshohada educational and treatment center in Urmia
Full name of responsible person
Nader Aghakhani
Street address
17 Shahrivar Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3237 5909
Email
nader1453@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Street address
Nazloo street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4961
Email
nader1453@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4916
Fax
+98 44 3275 4916
Email
nader1453@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 443275496
Email
nader1453@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 443275496
Email
nader1453@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintaining the principle of privacy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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