Objectives:The purpose of this study will be determined the impact of Benson Relaxation on the anxiety level of patients experiencing coronary angiography.
Design:This research will be a randomized clinical trial .
Setting and conduct:This study will be performed on a group of 73 patients hospitalized in Mazandaran Heart Center for coronary angiography in 2014. who will be randomly selected. They will be divided in two subject (34) and control (33) groups. Demographic data sheets, Spielberger state-trait anxiety inventory and recording sheet of homodynamic variables will be distributed among the two groups before and after Benson Relaxation.
Inclusion criteria: age of 30-90 years; undergoing coronary angiography for the first time; only undergoing coronary angiography; patients with full consciousness and not in critical conditions and having the ability to speak and hear
Exclusion criteria: lack of patient consent to continue participation in the study;having received a sedative within the past 8 hours; history of treatment with procedures similar to muscular relaxation and suffering from muscle paralysis.
Intervention:In relaxation group,One hour before angiography and immediately before the intervention, anxiety levels and vital signs will be recorded.This technique will be done, then anxiety levels and vital
signs will be recorded after 30 minutes at the end of relaxation . The participants will be received routine care,.
The control group will be received only routine care. Anxiety levels and vital signs will be measured 60 and 30 minutes prior to angiography.
The main outcome measures will be anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110087067N2
Registration date:2015-12-30, 1394/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Homyra Tahmasebi
Name of organization / entity
Sari branch, Islamic Azad University, Sari, Iran
Country
Iran (Islamic Republic of)
Phone
+98 15 1213 3857
Email address
htahmasebi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Sari Branch
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of Benson relaxation on the anxiety of patients experiencing coronary angiography
Public title
The impact of Benson relaxation on the anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 30-90 years; undergoing coronary angiography for the first time; only undergoing coronary angiography; patients with full consciousness and not in critical conditions and having the ability to speak and hear
Exclusion criteria: lack of patient consent to continue participation in the study;having received a sedative within the past 8 hours; history of treatment with procedures similar to muscular relaxation and suffering from muscle paralysis.
Age
From 30 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
How randomization was sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Sari Branch
Street address
7th km of sea Road(Farah Abad)
City
Sari
Postal code
Approval date
2014-08-13, 1393/05/22
Ethics committee reference number
1393-6
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobias
Primary outcomes
1
Description
Anxiety
Timepoint
one hour and 30 minutes before the angiography
Method of measurement
Spielberger standard questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
Hour and 30 minutes before the angiography
Method of measurement
Sphygmomanometer
2
Description
Pulse
Timepoint
Hour and 30 minutes before the angiography
Method of measurement
Physical examination
3
Description
Respiratory
Timepoint
Hour and 30 minutes before the angiography
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group:In subject group(relaxation group), the audio file for relaxation exercises will be provided to the patients and the exercises will be performed by the patients simultaneously in the presence of the researcher on the day before angiography.one hour before angiography anxiety levels and vital signs will be recorded immediately before the intervention. They will be received routine care, providing a calm and quiet environment and minimizing the environmental provocations, the patients will be listened to the audio file for relaxation techniques through headphones. In this technique, patients calmly lie on the bed with closed eyes and start to say the relaxing words (Like God; love; etc.) and mean while, deeply inhale through the nose and deeply exhale through the mouth and repeat the desired word in their mind and simultaneously relax their muscles from the fingertips upward until complete relaxation of all the muscles of the body. This condition will be maintained for 20 minutes and this technique was done before the angiography and then anxiety levels and vital signs will be recorded after 30 minutes at the end of relaxation.
Category
Prevention
2
Description
Control group: no intervention was done and only received routine care. Anxiety levels and vital signs were measured one hour and 30 minutes before the angiography. There was no intervention and placebo in this group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Dr.Vahid Mokhberi
Street address
Army Blvd , Square Municipality
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Farsi
Street address
7th km of sea Road(Farah Abad)
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Isamic Azad University
Full name of responsible person
Homyra Tahmasebi
Position
MSc
Other areas of specialty/work
Street address
7th km of sea Road(Farah Abad)
City
sari
Postal code
Phone
+961 133175540
Fax
Email
htahmasebi@iausari.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Nursing department
Full name of responsible person
Homyra Tahmasebi
Position
MSc
Other areas of specialty/work
Street address
7th km of sea Road(Farah Abad)
City
Sari
Postal code
Phone
+98 11 3317 5540
Fax
Email
hthahmasebi@yahoo.com;htahmasebi@iausari.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university sari branch
Full name of responsible person
Homyra Tahmasebi
Position
MSc
Other areas of specialty/work
Street address
7th km of sea Road(Farah Abad)
City
sari
Postal code
Phone
0098
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)