Effect of two relaxation methods Jacobson's and Benson's on anxiety and physiological indicators of patients before coronary artery angiography
Design
A clinical trial with a control group, one-way blind, single-center trial, randomized, 12 participants in 3 groups of 4 people.
Settings and conduct
The study is conducted on patients who refer to the angiography center of Kausar Hospital for coronary artery angiography.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 40 to 80 years; Not having mental, nervous and muscular diseases; No history of taking anti-anxiety and depression drugs in the last year; Absence of dangerous heart arrhythmia; The absence of an accident within a month before the intervention.
Exclusion Criteria: Intolerance of exercises and or the patient's deterioration; Occurrence of hemodynamic disorder and emergency conditions.
Intervention groups
Intervention group1: In Jacobson's relaxation group, patients are asked to contract and relax their muscles for 12 minutes according to the protocol one hour before coronary angiography.
Intervention group2: In Benson's relaxation group, patients are asked to contract and relax their muscles for 12 minutes according to the protocol one hour before coronary angiography. also, choose and repeat a soothing word that always reminds of relaxation and start breathing deeply and regularly.
Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group.
Main outcome variables
Anxiety, Blood pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N82
Registration date:2024-06-29, 1403/04/09
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-10-20, 1403/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of two relaxation methods Jacobson's and Benson's on anxiety and physiological indicators of patients before coronary artery angiography
Public title
Effect of two relaxation methods Jacobson's and Benson's on anxiety and physiological indicators of patients before coronary artery angiography
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 80 years
Not having mental, nervous and muscular diseases
No history of taking anti-anxiety and depression drugs in the last year
Absence of dangerous heart arrhythmia
The absence of an accident within a month before the intervention
Exclusion criteria:
Intolerance of exercises and or the patient's deterioration
Occurrence of hemodynamic disorder and emergency conditions
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Using Sealed Envelope software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
The participating person and the person who performs the statistical analysis do not know about the intervention modes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SEMUMS.REC.1403.001
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Using the Spielberger questionnaire
2
Description
Blood pressure
Timepoint
Before and after the intervention
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In Jacobson's relaxation group, patients are asked to contract and relax their muscles for 12 minutes according to the protocol one hour before coronary angiography.
Category
Rehabilitation
2
Description
Intervention group2: In Benson's relaxation group, patients are asked to contract and relax their muscles for 12 minutes according to the protocol one hour before coronary angiography. also, choose and repeat a soothing word that always reminds of relaxation and start breathing deeply and regularly.
Category
Rehabilitation
3
Description
Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mohamadreza Asgari
Street address
Street Amin, Semnan
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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