Protocol summary

Study aim
The effect of hot / cold water bath on the level of job fatigue and quality of life of health personnel working in intensive care units
Design
This study consists of two groups of 25 people intervention and control, which is done randomly by block method and by throwing dice.
Settings and conduct
Sampling and filling the forms is done in the intensive care unit of Qom hospitals. Putting feet in the water by the intervention group will be at home.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Personnel working in the intensive care units of Qom hospitals; willingness to participate in the project. Exclusion criteria: Pregnancy; serious skin disease.
Intervention groups
The intervention group: participants are recommended that one hour before bedtime or when they have at least 5 hours of continuous sleep, to put both feet, below the knee, in a container containing hot or cold water and after 15 minutes dry feet. water temperature in the cold seasons be 40-42 C and in hot seasons 10-15C. The control group will not take any action during this period.
Main outcome variables
Job fatigue; Satisfaction with quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220109053677N1
Registration date: 2022-02-17, 1400/11/28
Registration timing: prospective

Last update: 2022-02-17, 1400/11/28
Update count: 0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Fatemeh Tooiserkany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 4073
Email address
dr.tooiserkany@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of hot/cold water foot bath on the level of job fatigue and quality of life of health personnel of intensive health care units.
Public title
Investigating the effect of hot/cold water foot bath on the level of job fatigue and quality of life of health personnel of intensive health care units.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-70 years Informed consent to participate in the project Employment in the intensive care units of Qom hospitals.
Exclusion criteria:
Existence of serious heart, liver, kidney, and skin diseases Fever above 39 ° C Pregnancy and lactation Existence of wounds or lesions and active skin diseases in the legs and feet The unwillingness of the person to participate in the project.
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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating people will be done by block randomization method. Block size 4 is considered. So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. The selection of each block will also be random and will be done using dice. For example, if the number 3 is rolled in a dice, the BBAA block is considered, so the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown 13 times to complete the assignment of patients to treatment groups.
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 Qom University of Medical Sciences
Street address
Coastal Street. Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.MUQ.REC.1400.130

Health conditions studied

1

Description of health condition studied
Job fatigue
ICD-10 code
ICD-10 code description

2

Description of health condition studied
satisfaction with quality of life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Job fatigue
Timepoint
Upon entering the project, two weeks after entering the project (completion of the project)
Method of measurement
Fill out the questionnaire

2

Description
satisfaction with quality of life
Timepoint
Upon entering the project, two weeks after entering the project (completion of the project)
Method of measurement
Fill out the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: participants are recommended that one hour before bedtime or when they have at least 5 hours of continuous sleep, to put both feet, Below the knees, in a container containing hot or cold water, based on the season, and after 15 minutes dry feet. Water temperature must be, 40-42 C in cold seasons and 10-15 C in hot seasons.
Category
Prevention

2

Description
Control group: The control group will not take any action during this period.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Intensive care units of Qom hospitals
Full name of responsible person
Fatemeh Tooiserkany
Street address
15 Khordad St., corner of 44th Alley, Faculty of Traditional Medicine
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3776 4074
Fax
+98 25 3776 4074
Email
dr.tooiserkany@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Tooiserkany
Street address
15 Khordad St., corner of 44th Alley, Faculty of Traditional Medicine
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3776 4074
Fax
+98 25 3776 4074
Email
dr.tooiserkany@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Tooiserkany
Position
Physician specializing in Iranian traditional medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
15 Khordad St., corner of 44th Alley, Faculty of Traditional Medicine
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3776 4074
Fax
+98 25 3776 4074
Email
dr.tooiserkany@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Tooiserkany
Position
Physician specializing in Iranian traditional medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
15 Khordad St., more than 44th Alley, Faculty of Traditional Medicine
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3776 4074
Fax
+98 25 3776 4074
Email
dr.tooiserkany@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Tooiserkany
Position
Traditional medicine doctor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
15 Khordad St., more than 44th Alley, Faculty of Traditional Medicine
City
Qom
Province
Ghoum
Postal code
3713949373
Phone
+98 25 3776 4074
Fax
+98 25 3776 4074
Email
dr.tooiserkany@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Swedish Job Exhaustion Questionnaire and 12 Quality of Life Questionnaire
When the data will become available and for how long
Up to 3 months after completing the project to review and analyze the findings
To whom data/document is available
Executors
Under which criteria data/document could be used
To announce the effect or not of using foot water to relieve fatigue in the staff of hard boats.
From where data/document is obtainable
Executors
What processes are involved for a request to access data/document
Refer to Qom School of Traditional Medicine and the organizers of the project, namely Dr. Fatemeh Tuyserkani or Dr. Fatemeh Nojavan.
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