Determination and Comparison of the Effect of Reflective Massage and Progressive Muscle Relaxation on Anxiety in Patients with Acute Coronary Syndrome.
Design
A randomized clinical trial using blocking and sealed envelopes with parallel groups, without blinding with a sample size of 90 people (two 45-person randomized groups).
Settings and conduct
Sampling will perform among hospitalized patients in the cardiac care unit of Imam Hossein Hospital and Khatam Al-Anbia Hospital in Shahroud. Patients will be divided into two groups. Due to the nature of the study and the type of intervention, participants cannot be blinded. But data collectors and data analysts will be unaware of the patients' placement in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having mild anxiety based on questionnaire criteria; full alertness and ability to communicate; age: 18 to 75 years old; the patient has been hospitalized for at least 24 hours; stabilize patient status for sampling; having acute Coronary Syndrome. Exclusion criteria: En Dangerous arrhythmies and CPR cases in the ward; having a history of using psychotropic drugs based on patient statements and cases; drug and alcohol addiction citing the case; having a history of reflective massage and relaxation and psychotherapy; fractures, wounds and skin problems and the possibility of DVT at the Massage location; starting effective medicines in anxiety before intervention.
Intervention groups
Group A: Reflexive Foot Massage. Group B: Progressive Muscle Relaxation
Main outcome variables
Spielberger Anxiety Inventory (STAI) will be used in these patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191222045854N1
Registration date:2020-01-09, 1398/10/19
Registration timing:prospective
Last update:2020-01-09, 1398/10/19
Update count:0
Registration date
2020-01-09, 1398/10/19
Registrant information
Name
Maryam Bigom Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3237 2675
Email address
mb.hosseini@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the effect of foot reflexology massage and progressive muscle relaxation on anxiety in patients with acute coronary syndrome.
Public title
the effect of foot reflexology massage and progressive muscle relaxation on anxiety.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having mild anxiety based on questionnaire criteria
Full alertness and ability to communicate
Age:18 to 75 years old
The patient has been hospitalized for at least 24 hours
Stabilize patient status for sampling
Having acute Coronary Syndrome
Exclusion criteria:
Dangerous arrhythmies and CPR cases in the ward
Having a history of using psychotropic drugs based on patient statements and cases
Drug and alcohol addiction citing the case
Having a history of reflective massage and relaxation and psychotherapy
Fractures, wounds and skin problems and the possibility of DVT at the Massage location
Starting effective medicines in anxiety before intervention
Age
From 18 years old to 75 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
The method of randomization is tetragonal blocking and the randomization tool is the sealed envelope.
An statistic expert will accomplish the randomization sequence by using the suitable software.
Sampling will be done sequentially.
In order to concealment, given a code to each one, which the main researcher will not be aware.
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 Shahroud University of Medical Sciences
Street address
Shahrood University Of Medical Sciences, 7th Tir Square, Shahrood
City
Shahrood
Province
Semnan
Postal code
3614773947
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.SHMU.REC.1398.120
Health conditions studied
1
Description of health condition studied
Anxiety in Acute Coronary Syndrome Patients
ICD-10 code
F40-48
ICD-10 code description
Anxiety
Primary outcomes
1
Description
Anxiety in Acute Coronary Syndrome Patients
Timepoint
At baseline (before intervention) and three days after intervention
Method of measurement
Spiel Berger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
In group A, foot reflexology massage is performed for 3 days every 30 minutes 2 times a day and anxiety levels are measured and then the data will be analyzed.
Category
Other
2
Description
In group B, progressive muscle relaxation is performed for 3 days every 20 minutes 2 times a day. Anxiety levels are measured and the data are analyzed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Maryam Bigom Hosseini
Street address
Emam Ave, Emam Hossein Hospital
City
Shahrood
Province
Semnan
Postal code
3616911151
Phone
+98 23 3234 2000
Email
mb.hosseini@shmu.ac.ir
2
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
Maryam Bigom Hosseini
Street address
Tehran Ave, Khatam Al-Anbia Hospital
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
hosseini_maf22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Sharood University of Medical Sciences, 7th Tir Square
City
Sharood
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
vcr@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Bigom Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Ave, Khatam Al Anbia Hospital
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
Hosseini_maf22@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mryam Bigom Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Ave, Khatam Al Anbia
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
Hosseini_maf22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Bigom Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Ave, Khatam AL Anbia
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
mb.hosseini@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The obtained data after intervention on 90 participants in Imam Hossein and Khatam Al Anbia hospitals can be shared after unidentifiable individuals.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academies and scientific institutions, could access to data and documentation
Under which criteria data/document could be used
To promote and extend the subject under study from other aspects and to compare the results with other relevant scientific results, it is permissible to use documentation and data to improve the level of care.
From where data/document is obtainable
Hosseini_maf22@yahoo.com
What processes are involved for a request to access data/document
After reviewing the reason of requesting to access documentation and data by the researcher, the data and documentation file will be sent to the researcher (one month after submitting the request).