The effect of foot reflexology on comfort and physiological parameters in patients with acute coronary syndrome
Design
Patients randomly assigned to the intervention and control groups (68 patients each)
Will be allocated.
In group 1 (intervention group) patients will have reflexology once. The session will last 30 minutes for each leg for 15 minutes.
In the control group, patients do not receive any intervention from the researcher, and for the same interventions, the foot is touched once for 30 minutes without pressing each leg for 15 minutes.
Settings and conduct
In group 1 (intervention group) patients will have reflexology once. The session will last 30 minutes for each leg for 15 minutes.
In the control group, patients do not receive any intervention from the researcher, and for the same interventions, the foot is touched once for 30 minutes without pressing each leg for 15 minutes.The project will be implemented in Amir Kabir and Amiyalmomenin hospitals in Arak. The design is double-sided blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Willingness to participate in the study
2. Patients diagnosed with acute coronary syndrome by a specialist cardiologist
3. Age between 18 and 65 years
4. No other non-pharmacological relaxation interventions
5. Absence of scars on the legs
Exclusion criteria:
1. Unwillingness to continue participating in the study
2. Wounds in the legs
3. Patient's death
Intervention groups
In group 1 (intervention group) patients will have reflexology once. The session will last 30 minutes for each leg for 15 minutes.
In the control group, patients do not receive any intervention from the researcher.
Main outcome variables
1. Comfort
2. Physiological Indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039711N3
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Mohamad Golitaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.golitaleb@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-29, 1398/11/09
Expected recruitment end date
2020-05-29, 1399/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Foot Reflexology on Comfort And Physiological indices in Patients with Acute Coronary Syndrome
Public title
The effect of reflexology on comfort and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients with Acute Coronary Syndrome Admitted to Cardiac Care Unit
2. Willingness to participate in the study
3. Patients with a diagnosis Acute coronary syndrome by a cardiologist
4. Age between 18 and 65 years
5. No other non-pharmacological relaxation interventions
6. Absence of scars on the legs
Exclusion criteria:
1. Unwillingness to continue participating in the study
2. Wounds in the legs
3. Patient's death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, 17 blocks of 8 different letters of T and C are created (which represent the intervention and control groups) .68 individuals belong to the intervention group and 68 individuals belong to the control group.These blocks were then randomly selected to obtain a combination of 136 blocks, respectively. The resulting combination of letters is placed individually in 136 envelopes and each envelope is opened in order to determine which group the patient falls into.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, clinical caregivers, and data analysts are not aware of the patients assigned to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice-Chancellor of Education and Research Arak University of Medical Sciences., Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
7558538149
Approval date
2019-12-13, 1398/09/22
Ethics committee reference number
IR.ARAKMU.REC.1398.238
Health conditions studied
1
Description of health condition studied
Acute coronary syndrom
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Heart rate
Timepoint
Before and after intervention
Method of measurement
Heart rate (beats/min) will be measured with cardiac monitor
2
Description
Systolic pressure
Timepoint
Before and after intervention
Method of measurement
Systolic pressure (mmhg) will be measured with cardiac monitor
3
Description
Diastolic pressure
Timepoint
Before and after intervention
Method of measurement
Diastolic pressure (mmhg) will be measured with cardiac monitor
4
Description
Arterial Oxygen Saturation Percentage
Timepoint
Before and after intervention
Method of measurement
Pulse Oximeter
Secondary outcomes
1
Description
Comfort
Timepoint
Before and after intervention
Method of measurement
Kulkaba Convenience Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: In group 1 (intervention group), patients will have reflexology once. The session will last 30 minutes for each leg for 15 minutes.
Category
N/A
2
Description
Control group: In the control group, patients do not receive any intervention from the researcher, and for the same interventions, the foot is touched once for 30 minutes without pressing each leg for 15 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mohamad Golitaleb
Street address
Basij square. Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa
2
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Mohamad Golitaleb
Street address
Amir Kabir Hospital .Nursing Square - Shiroudi Street .Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirkabirhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3506
Fax
+98 86 3223 1283
Email
m.golitaleb@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://arakmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All information and results will be mentioned in the final report and article.
When the data will become available and for how long
All information and results will be mentioned in the final report and article.
To whom data/document is available
All information and results will be mentioned in the final report and article.
Under which criteria data/document could be used
All information and results will be mentioned in the final report and article.
From where data/document is obtainable
All information and results will be mentioned in the final report and article.
What processes are involved for a request to access data/document
All information and results will be mentioned in the final report and article.
Comments
All information and results will be mentioned in the final report and article.