Comparing the effect of foot and hand reflexology on pain severity and anxiety in cardiac care unit patients in Imam Khomeini hospital in Khomein city.
Comparing the effect of hand and foot reflexology on the anxiety and pain of patients hospitalized in CCU to increase the quality of life of patients hospitalized in CCU.
Design
Clinical trial with parallel groups, randomized, on 70 patients. For randomization, the method of random allocation of numbers and lottery will be used.
Settings and conduct
Imam Khomeini Hospital, Khomein city, with randomized clinical trial method
Pain will be measured with the VAS scale and anxiety with the Spielberger questionnaire.
Participants/Inclusion and exclusion criteria
• Willingness to participate in the study
• Age 20 to 70 years
• Not being pregnant
• Having heart disease
•
Intervention groups
After assigning the patients to two hand and foot groups, each of them will receive their own intervention (hand or foot reflexology) and their results will be compared with each other.
Main outcome variables
pain-anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240609062052N1
Registration date:2024-06-22, 1403/04/02
Registration timing:prospective
Last update:2024-06-22, 1403/04/02
Update count:1
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Pouya Zeidy
Name of organization / entity
Khomein University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 2435
Email address
zeidypouya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-27, 1403/04/07
Expected recruitment end date
2024-07-29, 1403/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of foot and hand reflexology on pain severity and anxiety in cardiac care unit patients in Imam Khomeini hospital in Khomein city.
Public title
Comparing the effect of foot and hand reflexology on pain severity and anxiety in cardiac care unit patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
be a cardiac patient
orientation to place & time & persons
age between 20 to 70 years old
Exclusion criteria:
be pregnanted
be a malignant patient
have any fracture at feet or hands
be a hand or foot amputated person
be sensitive to hand or foot massage
be an unstable angina case
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After sampling in an accessible (easy) method, the names of all 70 patients that are selected are written on a sheet in a completely random column, then from the first column on the left from top to bottom to each name We start allocating numbers from 1 to 70, and then the next column until the last person. Finally, we assign even numbers to the hand intervention group and odd numbers to the foot intervention group.
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 Khomein Faculty of Medical Sciences
Street address
Khomein, Azadi Street, Khomein Faculty of Medical Sciences
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.KHOMEIN.REC.1403.009
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
2
Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris
3
Description of health condition studied
Other acute ischemic heart diseases
ICD-10 code
I24
ICD-10 code description
Other acute ischemic heart diseases
4
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
5
Description of health condition studied
Atherosclerosis
ICD-10 code
I70
ICD-10 code description
Atherosclerosis
6
Description of health condition studied
Hypertensive heart disease
ICD-10 code
I11
ICD-10 code description
Hypertensive heart disease
7
Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Before and after the intervention
Method of measurement
Anxiety:Spielberger questionnaire
2
Description
pain score according to VAS criteria
Timepoint
Before and after the intervention
Method of measurement
Pain: Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hand reflexology group In this intervention, 35 patients hospitalized in the CCU department, who were assigned to the hand group by a simple random method, first completed the demographic information questionnaire, Spielberger and the visual pain scale (VAS). Then the patients, twice They undergo hand massage therapy once a week (for 30-40 minutes each time) for 6 weeks. Reflexology is performed using a lubricating fluid (natural sunflower oil) to reduce friction on the hands and feet. At first, general massage for 5 minutes on the right hand and back, reflexology by performing special movements of both hands for 10 minutes.; Then the Spielberger questionnaire and the VAS criterion will be completed again.
Category
Other
2
Description
Intervention group: foot reflexology group In this intervention, 35 patients hospitalized in the CCU department, who were assigned to the foot group by a simple random method, first completed the demographic information questionnaire, Spielberger and visual pain scale (VAS). Then the patients undergo massage therapy twice a week (for 30-40 minutes each time) for 6 weeks. Reflexology is performed using a lubricating fluid (natural sunflower oil) to reduce friction on the feet. At first, general massage for 5 minutes on the right leg and back, reflexology is performed by performing special movements of two hands in the area related to the heart for 10 minutes. Then the Spielberger questionnaire and the VAS criterion will be completed again. At the end of this intervention, the results of two interventions will be compared with one another.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام خمینی(ره)
Full name of responsible person
Pouya zeidy
Street address
shahid Beheshti blvd
City
khomein
Province
Markazi
Postal code
۳۸۸۱۹۵۵۵۳۳
Phone
+98 86 4633 9982
Email
khomeinhospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein Faculty of Medical Sciences
Full name of responsible person
Abbas Farahani
Street address
Khomein,Quds square
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
info@khomeinums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein Faculty 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
Khomein Faculty of Medical Sciences
Full name of responsible person
Pouya Zeidy
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Varabad Village
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 3435
Email
zeidypouya@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein Faculty of Medical Sciences
Full name of responsible person
Mahdi Safar Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Quds square,khomein faculty of medical sciences
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mahdisafarabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Pouya Zeidy
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Khomein university of science-Quds Boulevard-Quds Avenue
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4633 2435
Fax
Email
zeidypouya@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All information and data will be shared after de-identifying people.
When the data will become available and for how long
Access will start 1 month after the results are published.
To whom data/document is available
All people related to medical and health matters
Under which criteria data/document could be used
The use of data will only be subject to mention of the source of the study and the authors.
It is definitely necessary to obtain permission from the authors and researchers of the study.
From where data/document is obtainable
with this emali: zeidypouya@gmail.com
What processes are involved for a request to access data/document
After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester.