Protocol summary

Study aim
The Effect of Foot Reflexology Massage on Physiological Indices in Stroke Patients
Design
A clinical trial with a control group, one-blind, randomized on 60 patients
Settings and conduct
This study was performed on patients with stroke in the neurology department of Ali Ibn Abi Taleb Hospital in Rafsanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of stroke; GCS over 7; age over 30 years; heart rate greater than 60 beats per minute; temperature greater than 36.5 °C and systolic blood pressure higher than 90. Non inclusion criteria: Arrhythmia; taking nitroglycerin-dopamine and Dobutamine drugs; have a history of drug abuse (addiction); not tolerating the intervention and having a history of mental illness.
Intervention groups
In the Intervention group, the researcher carries a reflective massage for 30 minutes (15 minutes for each foot). In this method, reflection points of soles (solar network and the pituitary related points) are pressed using the index and thumbs fingers. Control group receive simple massage on the foot.
Main outcome variables
Blood pressure; heart rate; temperature; respiration; percentage of arterial oxygen saturation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20180304038936N3
Registration date: 2018-09-04, 1397/06/13
Registration timing: registered_while_recruiting

Last update: 2018-09-04, 1397/06/13
Update count: 0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Ahmadreza Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
a.sayadi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-23, 1397/02/03
Expected recruitment end date
2019-04-23, 1398/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology Massage on Physiological Indices in Stroke Patients
Public title
The Effect of foot reflexology massage on physiological indices
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of stroke level of consciousness (GCS ) over 7 Age over 30 years Heart rate greater than 60 beats per minute Temperature greater than 36.5 ° C Systolic blood pressure higher than 90
Exclusion criteria:
Patients with arrhythmia Patients who are taking nitroglycerin-dopamine and Duobutamin drugs Have a history of drug use Do not tolerate intervention Have a history of mental illness Have acute conditions during the intervention
Age
To 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization by minimization method based on age and blood pressure variables.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not know which group is being investigated as intervention group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍٍEthics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7717933777
Approval date
2018-04-17, 1397/01/28
Ethics committee reference number
IR.RUMS.REC.1397.020

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Mean of blood pressure
Timepoint
10 minutes before intervention, immediately after intervention, 10 minutes after intervention and 30 minutes after intervention
Method of measurement
Alpk2 sphygmomanometer

2

Description
Number of respiration per minute
Timepoint
10 minutes before intervention, immediately after intervention, 10 minutes after intervention and 30 minutes after intervention
Method of measurement
Counting number of breaths

3

Description
Mean of temperature
Timepoint
10 minutes before intervention, immediately after intervention, 10 minutes after intervention and 30 minutes after intervention
Method of measurement
Easylife digital termometer

4

Description
Number of heart rate per minute
Timepoint
10 minutes before intervention, immediately after intervention, 10 minutes after intervention and 30 minutes after intervention
Method of measurement
PC-66B pulse oximeter device

5

Description
Percentage of oxygen saturation of arterial blood
Timepoint
10 minutes before intervention, immediately after intervention, 10 minutes after intervention and 30 minutes after intervention
Method of measurement
PC-66B pulse oximeter device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group receive reflexology massage for 30 minutes (15 minutes for each foot) on the second day of hospitalization. In this method, reflection points of soles (solar network and the pituitary-related points) are pressed using the index finger and thumbs.
Category
Other

2

Description
Control group: This group receive simple massage for 30 minutes (15 minutes for each foot) on the second day of hospitalization.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abi Taleb Hospital
Full name of responsible person
Azam Talebi
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Email
a.talebi307@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmad Reza Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Email
a.sayadi@rums.acir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmad Reza Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Email
a.sayadi@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmad Reza Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Country
Iran (Islamic Republic of)
Postal code
7718796755
Phone
+98 34 3425 5900
Email
a.sayadi@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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