The Effect of Benson´s relaxation on anxiety and physiological parameters on candidate of open heart surgery patients in selected hospitals of AJA University Medical Science.
This study is a clinical trial was performed on 90 patients undergoing open heart surgery. The main inclusion criteria included aged 20 to 70 years old; Absence of trouble hearing; Unfamiliarity with the same periods with Benson’s relaxation in the experimental and control groups; Absence of musculoskeletal system disorder; The ability to communicate in Persian language; The ability to taking Benson’s relaxation training; Absence of contraindications to control blood pressure and pulse of the right hand and The main exclusion criteria Included unwillingness to continue cooperation in the study at any time of the study. Data collection instruments included a demographic questionnaire, and the Spielberg’s anxiety inventory. The patients were randomly assigned into two experimental and control groups. Anxiety levels in two groups the day before surgery measuring by questionnaire Spielberg’s anxiety and then in the experimental group were trained Benson’s relaxation. In the morning of surgery, Benson’s relaxation were performed by the experimental group and then anxiety levels and physiological parameters control and evaluation in both groups about half an hour before was sent to the operating room. Finally data analyzed was performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121520328N1
Registration date:2015-08-26, 1394/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-26, 1394/06/04
Registrant information
Name
Mahdi Malmir
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 88028350
Email address
mahdimalmir@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA University Medical Science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Benson´s relaxation on anxiety and physiological parameters on candidate of open heart surgery patients in selected hospitals of AJA University Medical Science.
Public title
The Effect of Benson´s relaxation on anxiety in candidate of open heart surgery patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 20 to 70 years old; Absence of trouble hearing; Absence of psychiatric illness recognized; Not use sedative or anti-anxiety drugs except of the routine method; Not having with substance abuse; Unfamiliarity with the same periods with Benson’s relaxation in the experimental and control groups; Absence of musculoskeletal system disorder; The ability to communicate in Persian language; The ability to taking Benson’s relaxation training; Absence of contraindications to control blood pressure and pulse of the right hand.
Exclusion criteria: Unwillingness to continue cooperation in the study at any time of the study.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
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
AJA University of Medical Science
Street address
Adjacent to Imam Reza (AS) Hospital, Martyr St. Etemadzadeh,Tehran
City
Tehran
Postal code
Approval date
2014-09-27, 1393/07/05
Ethics committee reference number
9319
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease Coronary (artery)
Primary outcomes
1
Description
anxiety
Timepoint
During two days
Method of measurement
Spielberg’s anxiety inventory
2
Description
physiological parameters
Timepoint
During two days
Method of measurement
A stethoscope and sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Anxiety levels in two groups the day before surgery measuring by questionnaire Spielberg’s anxiety and then in the experimental group were trained Benson’s relaxation. In the morning of surgery, Benson’s relaxation were performed by the experimental group and then anxiety levels and physiological parameters control and evaluation in both groups about half an hour before was sent to the operating room.
Category
Other
2
Description
In the control group routine care done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Hospital of AJA University of Medical Sciences (Hospital 502)
Full name of responsible person
Dr.Mohammad Ali Bayanfar
Street address
Intersection of Taleghani and Bahar Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AJA University of Medical Science
Full name of responsible person
Dr. Armin Zareian
Street address
Shariati Ave. Kaj St. Aja College of Nursing
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Mahdi Malmir
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Aja College of Nursing
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
mahdimalmir@ajaums.ac.irmalmir65@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Teimouri
Position
Mentor
Other areas of specialty/work
Street address
AJA College of Nursing
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
fatemeh teimouri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA university of medical sciences
Full name of responsible person
Mahdi Malmir
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
AJA College of Nursing
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
mahdimalmir@ajaums.ac.irmalmir65@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)