Determine the effectiveness of foot massage on physiological parameters (heart rate, respiration, mean arterial pressure, pulse pressure, peripheral oxygen saturation ) among patients with acute coronary syndrome.
Design
A quasi experimental design on non random in patient with acute coronary syndrome with minimum
sample size of 30 for each group will be used; the total size 60 patient enrolled between December 2023 to
September 2024.
Settings and conduct
The study was conducted in karbala heart center in Karbala Governorate, Iraq.
Participants/Inclusion and exclusion criteria
The Inclusion Criteria: All patient Those who are surgical diagnosed with acute coronary syndrome .
patient between age 18 and over. Participants with Iraqi nationality. Conscious patient, able to communicate verbally, and able to make decision.
Exclusion criteria: patient who declined to enroll in the study and who have discontinuing to intervention.
Patients could have foot problems (such as callus, corn, fungal skin infection, previous scars, diabetic foot or known neuropathy). patient who have amputation in lower extremity.
Intervention groups
Data will be collected using the pre- and post-test methods. After assessing the physiological parameters the sample will be allocated into two groups: (Group 1)was applied for five minutes, each foot was massaged for five minutes. and followed four steps of foot massage, All of the four steps was given one minute and fifteen seconds of massage, which was five minutes in total, The physiological parameters of the client were documented before the massage and then the massage was implemented for five minutes. and re-recorded the Physiological parameters in the five and ten minutes after the end of five minutes of foot massage. and Group 2: control group without any intervention.
Main outcome variables
Reduce the physiological parameters.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240124060784N1
Registration date:2024-04-04, 1403/01/16
Registration timing:registered_while_recruiting
Last update:2024-04-04, 1403/01/16
Update count:0
Registration date
2024-04-04, 1403/01/16
Registrant information
Name
zainab sabah
Name of organization / entity
Kerbala university
Country
Iraq
Phone
+964 781 873 9384
Email address
zainab.sabah@s.uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-31, 1402/11/11
Expected recruitment end date
2024-03-08, 1402/12/18
Actual recruitment start date
2024-02-10, 1402/11/21
Actual recruitment end date
2024-06-25, 1403/04/05
Trial completion date
2024-07-01, 1403/04/11
Scientific title
Effectiveness of foot massage on physiological parameters among patients with acute coronary syndrome
Public title
Effectiveness of foot massage on physiological parameters among patients with acute coronary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patient Those who are surgical diagnosed with acute coronary syndrome .
Patient between age 18 and over
Participants with Iraqi nationality.
Conscious patient, able to communicate verbally, and able to make decision.
Exclusion criteria:
Patient who declined to enroll in the study and who have discontinuing to intervention.
Patients could have foot problems (such as callus, corn, fungal skin infection, previous scars, diabetic foot or known neuropathy).
Patient who have amputation in lower extremity
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Zainab Sabah Sagheer Almasoudi
Street address
Al-ibrahemia street
City
Karbala
Postal code
10053
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
4626
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
NEC-I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
The primary outcome variable is the physiological parameters change due to foot massage
Timepoint
Before intervention and after five , ten minutes from foot massage
Method of measurement
Physiological parameters chick list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Foot massage was applied for five minutes, each foot was massaged for five minutes. and followed four steps of foot massage , All of the four steps was given one minute and fifteen seconds of massage, which was five minutes in total, The physiological parameters of the client were documented before the massage and then the massage was implemented for five minutes. and re-recorded the Physiological parameters in the five and ten minutes after the end of five minutes of foot massage . After putting a pillow under the patient's feet and positioning them in a supine position at a 30-degree angle to their head, and lubricated the hand with olive oil and began the massage by followed the four steps .1- With one hand, the sole of the foot was grasped, and the toes were checked to ensure they were directed upward. Then pressure was applied to the back of the foot by running the thumb slowly into each groove created by the tendons connecting the ankle to the toes.2- While the other thumb was softly massaging the entire sole of the foot, one hand was used to hold the foot.3- The fingers were bent backward and forward while also being separately pulled to one side in a balanced manner.4- Between the thumb and toes, the base of each finger was grasped, pulled along, and bent outward. All participants continued to receive their conventional therapy.
Category
Treatment - Other
2
Description
Control group: received no intervention ;instead they received pretest and post test assessment after five and ten minutes, as did the other groups ,and they will be compared to the other groups in the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
karbala heart center
Full name of responsible person
Karbala Health Directorate
Street address
Al- ibrahemia street
City
Karbala
Postal code
10053
Phone
+964 781 873 9384
Email
www.zainab.sabah@s.uokerbala.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of kerbala
Full name of responsible person
zainab sabah sagheer almasoudi
Street address
Al-ibrahemia street
City
Karbala
Postal code
10053
Phone
+964 781 873 9384
Email
www.zainab.sabah@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
University of Kerbala
Full name of responsible person
Zainab Sabah Sagheer Almasoudi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-ibrahemia street
City
Karbala
Province
Karbala
Postal code
10053
Phone
+964 781 873 9384
Email
www.zainab.sabah@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of kerbala
Full name of responsible person
Zainab Sabah Sagheer Almasoudi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-ibrahemia street
City
Karbala
Province
Karbala
Postal code
10053
Phone
+964 781 873 9384
Email
www.zainab.sabah@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Person responsible for updating data
Contact
Name of organization / entity
University of kerbala
Full name of responsible person
Zainab Sabah Sagheer Almasoudi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-ibrahemia street
City
Karbala
Province
Karbala
Postal code
10053
Phone
+964 781 873 9384
Email
www.zainab.sabah@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
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
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 data will be the results of the acute coronary syndrome Patient
with physiological parameters in Both the Control and
Intervention Groups .
When the data will become available and for how long
God Willing, once the article is published, the data will be
available after 6 months of publication. If the article will
be published in a subscribed journal, the data will be
available after one year because of the policy of the
subscribed journals.
To whom data/document is available
with academic nurses and any researcher who is
interested in the data.
Under which criteria data/document could be used
The data could be used after getting permission via
email. Also, users need to acknowledge the owner.
From where data/document is obtainable
Users can ask for the data and permission via email.
zainab al-masoudi is the corresponding author. He will
contact whoever he requests the information from. her
email is zainab . sabah@uokerbala.edu.iq zainab sabah
works at the University of Kerbala/College of Nursing.
The address is Al-Muadhafeen district, Karbala, Iraq.
What processes are involved for a request to access
data/document
What processes are involved for a request to access data/document
Users can ask for the data and permission via email.
zainab sabah is the corresponding author. He will
contact whoever he requests the information from. His
email is zainab . sabah@uokerbala.edu.iq
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