Protocol summary

Study aim
Effect of foot bath on physiological indexes and anxiety levels in patients with acute stroke
Design
In this study, 60 patients were randomly divided into two groups intervention (n = 30) and controls (n = 30) using sealed envelopes.
Settings and conduct
After obtaining the necessary permission, a study is conducted on patients with stroke admitted to the neurology department of Tohid Hospital in Sanandaj. Following the explanation of the research and obtaining written consent from them and ensuring the confidentiality of their information, they are selected as samples. The study is one-sided, and the data will be analyzed without informing the advisors of the type of groups.
Participants/Inclusion and exclusion criteria
Being patient alert, Age >30, Being healthy at least one of the lower extremities of sensation and movement,Diagnosis of stroke by physician, The absence of acute and severe hemodynamic disorders, Not having a history of drug use, Lack of skin disorders in the lower extremities, Non-deformity in the lower limbs, Lack of abnormal blood supply and oxygenation to the lower extremities, Lack of musculoskeletal disorders in the lower extremity
Intervention groups
In the test group, the patient is first seated for 10 minutes at the edge of the bed, and immediately for 15 minutes, the foot bath is done using a foot bath in a sitting position on the bed edge, and then the legs of the patient will be dried with a disposable towel. Patients in the control group do not receive any interventions and sit only on the edge of the bed for only 10 minutes.
Main outcome variables
Temperatures blood pressure heart beat Respiratory rate Percentage of arterial oxygen saturation Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180411039274N1
Registration date: 2018-08-02, 1397/05/11
Registration timing: registered_while_recruiting

Last update: 2018-08-02, 1397/05/11
Update count: 0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Fazel Dehvan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 6141
Email address
dehvan.f@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot bath on physiological parameters and anxiety levels in patients with acute stroke hospitalized in the neurology Ward of Towhid hospital in Sanandaj, 2018
Public title
The effect of foot bath on physiological parameters and anxiety levels in patients with acute stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being patient alert, Age >30, Being healthy at least one of the lower extremities of sensation and movement,Diagnosis of stroke by physician, The absence of acute and severe hemodynamic disorders, Not having a history of drug use, Lack of skin disorders in the lower extremities, Non-deformity in the lower limbs, Lack of abnormal blood supply and oxygenation to the lower extremities, Lack of musculoskeletal disorders in the lower extremity
Exclusion criteria:
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the method of Flip the coin and according to the size of the sample, the Flip the coin are repeated
Blinding (investigator's opinion)
Single blinded
Blinding description
Assigning proprietary code to questionnaires and the questionnaire will be provided to the statistics consultant for analysis without specifying the name of the group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Street, Kurdistan University of Medical Sciences, Sanandaj city
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.MUK.REC.1397/58

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
Anxiety
Timepoint
Before and after intervention in each of the groups
Method of measurement
Anxiety Measurement Using Spielberger Standard Questionnaire

2

Description
blood pressure
Timepoint
Before intervention And immediately, 15 minutes later and half an hour after the end of the intervention
Method of measurement
Using the Digital Pressure Gauge, Buerer Mark, Made in Germany

3

Description
Temperatures
Timepoint
Before intervention And immediately, 15 minutes later and half an hour after the end of the intervention
Method of measurement
Using a tempanic digital thermometer

4

Description
Heart Rate
Timepoint
Before intervention And immediately, 15 minutes later and half an hour after the end of the intervention
Method of measurement
Using the touch of the apex area

5

Description
Respiratory Rate
Timepoint
Before intervention And immediately, 15 minutes later and half an hour after the end of the intervention
Method of measurement
By observing the movements of the chest in a minute

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In order to intervene in the test group, the patient is first placed on the edge of the bed for 10 minutes and will be done for 15 minutes using the foot bath (FB25- Beurer Made in Germany) in the sitting position on the bed edge (chair).And then the patient's legs are dried with disposable towel. During this period, the investigator will not talk with the patient to influence the patient's anxiety.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital in Sanandaj
Full name of responsible person
Fazel Dehvan
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Faculty of Nursing and Midwifery, Sanandaj City
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Email
dehvan.f@muk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fazel Dehvan
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Email
dehvan.f@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Fazel Dehvan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Faculty of Nursing and Midwifery
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Email
dehvan.f@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
fazel dehvan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Faculty of Nursing and Midwifery
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Email
dehvan.f@muk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
fazel dehvan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Faculty of Nursing and Midwifery
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Email
dehvan.f@muk.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
Yes - There is a plan to make this available
Title and more details about the data/document
All individual participant data is shared after being unidentified
When the data will become available and for how long
Start the access period 7 months after publishing the results
To whom data/document is available
Data is only available for academic scholarly researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
fazel dehvan - dehvan.f@muk.ac.ir - 00988733664645
What processes are involved for a request to access data/document
Sending a request to my email (dehvan.f@muk.ac.ir ) will be answered after 10 - 15 days
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