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The effect of foot reflexology on fatigue, sleep quality, physiological indices and electrocardiogram changes in acute myocardial infarction patients

Protocol summary

Study aim
The effect of foot reflexology on fatigue, sleep quality, physiological indices and electrocardiogram changes in acute myocardial infarction patients
Design
A clinical trial with control group, parallel group randomized trial, a single blinded
Settings and conduct
Setting: CCU wards in Al-Zahra Hospital, Data collector and statistician are blind.
Participants/Inclusion and exclusion criteria
The inclusion criteria were having acute myocardial infarction, being 18-75 years old, speak Persian language and oriented to time, person and place. The patients with infectious or bleeding ulcer in their legs, having previous history of cardiovascular diseases, inability to tolerate foot reflexology; and physical disability would be excluded.
Intervention groups
Intervention group: The patient lays on a bed in a quiet environment. The therapist places at the below of the patient's bed and each foot receives a reflexology for 15 minutes. reflexology will be done in three consecutive days at 4 pm. In order to do reflexology, firstly, the sweet almond oil is used. Then the reflexology would be done on following points the sleep points consisted of the thumb and Solar plexus, the inner and outer edges, soles and heel to the ankle of the foot which relate to the fatigue. Moreover, reflexology would be done on both the soles, between the shoulder line and diaphragm line in heart and chest reflex areas. The control group does not receive any type of reflexology. This group receives routine care such as the intervention group.
Main outcome variables
Fatigue, sleep quality, physiological indices and electrocardiogram changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130616013690N8
Registration date: 2021-03-17, 1399/12/27
Registration timing: prospective

Last update: 2021-03-17, 1399/12/27
Update count: 0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on fatigue, sleep quality, physiological indices and electrocardiogram changes in acute myocardial infarction patients
Public title
The effect of foot reflexology on acute myocardial infarction patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with acute myocardial infarction Being 18 years old or above Speak Persian language being orient to time, person and place
Exclusion criteria:
Infection or bleeding ulcer in the patient legs Having previous history of cardiovascular diseases Inability to tolerate foot reflexology Having physical disability
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, the patients are included in the study using convenience sampling. Then, a random block with four block is used to randomly assign patients into the both groups. Block list is provided by the "Create a block randomization list" software. Each block is then placed inside a envelope and numbered. In this way, after selecting a patient, a numbered envelope is opened, the patient is allocated into the intervention or control groups based on the contents of envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
To conducting blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.SUMS.REC.1399.1278

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
ST elevati
ICD-10 code description
121

Primary outcomes

1

Description
Fatigue
Timepoint
30 minutes before the intervention and four days after the intervention at 8:00 A.M.
Method of measurement
Multidimensional Fatigue Inventory

2

Description
Quality of sleep
Timepoint
30 minutes before the intervention and four days after the intervention at 8:00 A.M.
Method of measurement
Pittsburgh Sleep Quality Index

3

Description
Physiological indices
Timepoint
30 minutes before the intervention and every day from second to fourth days at 7 A.M.
Method of measurement
Digital heart monitoring device

4

Description
Tempreture
Timepoint
30 minutes before the intervention and every day from second to fourth days at 7 A.M
Method of measurement
MASTECH Non Contact Infrared Medical Thermometer

5

Description
peripheral blood oxygen saturation level
Timepoint
30 minutes before the intervention and every day from second to fourth days at 7 A.M
Method of measurement
Pulse Oximeter

6

Description
Electrocardiogram changes
Timepoint
30 minutes before the intervention and every day from second to fourth days at 7 A.M.
Method of measurement
Digital heart monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patient lays on a bed in a quiet environment. The therapist places at the below of the patient's bed and each foot receives a reflexology for 15 minutes. reflexology will be done in three consecutive days at 4 pm. In order to do reflexology, firstly, the sweet almond oil is used. Then the reflexology would be done on following points the sleep points consisted of the thumb and Solar plexus, the inner and outer edges, soles and heel to the ankle of the foot which relate to the fatigue. Moreover, reflexology would be done on both the soles, between the shoulder line and diaphragm line in heart and chest reflex areas.
Category
Prevention

2

Description
Control group: The control group does not receive any type of reflexology. This group receives routine care such as the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Heart Center
Full name of responsible person
Masoume Rambod
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
rambodma@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor for research affairs of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
21255
Grant code / Reference number
21255
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71936–13119
Phone
+98 71 3677 4254
Email
rambodma@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.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
Primary outcomes would be shared.
When the data will become available and for how long
Starting 6 months after publication article
To whom data/document is available
People and researchers working in academic institutions
Under which criteria data/document could be used
Data are provided for information only.
From where data/document is obtainable
Data is available via email rambodma@yahoo.com.
What processes are involved for a request to access data/document
Data is available via email rambodma@yahoo.com.
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