This study is a randomized control trial to determine the Effect of Benson relaxation technique on anxiety and comfort in patients before CABG, who were referred to Buali Hospital in Ghazvin City, were our statistical research community. Of them, 64 patients were selected based on inclusion criteria and they were randomly divided into two experimental and control groups using table of random numbers. For relaxation intervention groups for two sessions of practice on the evening before and the morning of surgery for every 30 minutes was conducted by headphone. Patients filled kolcaba comfort and Eshpel Burgers anxiety Inventory before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042133005N1
Registration date:2017-04-21, 1396/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Masoumeh Sahrakhil
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 28 2282 5065
Email address
msahrakheil@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2016-10-23, 1395/08/02
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson relaxation technique on anxiety and comfort in patients before CABG
Public title
Effect of Benson relaxation technique on anxiety and comfort
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Experience first open heart surgery and other emergency and coronary artery bypass; the age of 30 years and older, sober, understanding content in Farsi; no history of psychiatric diseases known, no addiction to drugs and alcohol, lack of skin problems. Exclusion criteria: withdrawal to continue cooperation; Death of a patient; changes in hemodynamic status
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers was used For randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch
Street address
khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
Approval date
2016-10-23, 1395/08/02
Ethics committee reference number
ir.iau.tmu.rec.1395.217
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I70-I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Eshpel Burgers' anxiety questionnaire
2
Description
Comfort
Timepoint
before and after intervention
Method of measurement
Colkaba comfort inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the patients in this group received two sessions of practice on the evening before and the morning of surgery for every 30 minutes was conducted by headphone
Category
Other
2
Description
Control group: There was no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
BuAli Hospital
Full name of responsible person
Masoumeh sahrakhil
Street address
Adl Blvd, Ferdosi Street, Ghazvin, Iran
City
Ghazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
Full name of responsible person
Masoumeh Sahrakhil
Street address
Shariati Avenue, Khaghani Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
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
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Masoumeh sahrakhil
Position
Master student of nursing
Other areas of specialty/work
Street address
Shariati Avenue, Khaghani Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8355 3970
Fax
Email
masumesahra67@ yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Tahereh Nasrabadi
Position
PhD of nursing
Other areas of specialty/work
Street address
Shariati Avenue, Khaghani Street, Tehran
City
Tehran
Postal code
Phone
+98 21120391947
Fax
Email
Taherehnasrabdi2009@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Masoumeh Sahrakhil
Position
Master student of nursing
Other areas of specialty/work
Street address
Shariati Avenue, Khaghani Street, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
masumesahra67@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)