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The Effect Of Foot Reflexology Massage On Fatigue And Sleep Quality In Hemodialysis Patients: A Randomized Control Trial

Protocol summary

Study aim
Determining the effect of foot reflexology massage on fatigue and sleep quality of hemodialysis patients
Design
50 hemodialysis patients will be selected in two groups, control and intervention, using random allocation methods.
Settings and conduct
The research environment will be the hemodialysis department of Sina Hospital in Zarand city. After coordinating with the supervisor of the hemodialysis department, he will introduce the patients who meet the conditions to enter the study. The patients were divided into two control groups and three questionnaires of demographic information, Pittsburgh Sleep Quality Index (PSQI) and Piper Fatigue Scale will be completed by the patients of both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 18 years old, dialysis treatment for at least 3 months, hemodialysis treatment 3 times a week and each time for 4 hours, no limb amputation or wound at the place of massage, no chronic diseases.( Heart Failure, Rheumatoid Arthritis, Lupus Erythematous) Exclusion criteria: age less than 18 years, dialysis treatment less than 3 months, having limb amputation or wound at the place of massage, suffering from chronic diseases ( heart failure, rheumatoid arthritis, lupus erythematosus)
Intervention groups
Patients in the intervention group are placed on their stomachs in a relaxed and sleeping position during three 16-minute sessions per week for 4 weeks, and then the masseur applies pressure on the solar plexus points on the soles of the feet. Patients in the control group will receive only simple touch without pressure on the solar plexus points.
Main outcome variables
Mental or physical feeling affecting people's functioning, Enjoying a person's sleep with the highest functional level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231016059742N1
Registration date: 2023-11-16, 1402/08/25
Registration timing: prospective

Last update: 2023-11-16, 1402/08/25
Update count: 0
Registration date
2023-11-16, 1402/08/25
Registrant information
Name
Raheleh rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3342 5400
Email address
r.rajabi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Foot Reflexology Massage On Fatigue And Sleep Quality In Hemodialysis Patients: A Randomized Control Trial
Public title
The Effect Of Foot Reflexology Massage On Fatigue And Sleep Quality In Hemodialysis Patients: A Randomized Control Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old Dialysis treatment for at least 3 months Treatment with hemodialysis 3 times a week and each time for 4 hours Not suffering from chronic and debilitating diseases (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus erythematosus) No obvious physical disability or mental disorder that the person cannot take care of himself
Exclusion criteria:
Age less than 18 years Treatment with dialysis less than 3 months Having a limb amputation or wound at the massage site Suffering from chronic and debilitating diseases (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus erythematosus) Physical disability or obvious mental disorder that makes the person unable to take care of themselves
Age
From 18 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
The sample number of 50 people (hemodialysis patients) will be selected by the available method and will be divided into two intervention and control groups (25 people in each group) using the minimization random allocation method.
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 Kerman University of Medical Sciences
Street address
Imam Khomeini street
City
zarand
Province
Kerman
Postal code
7616913555
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.KMU.REC.1402.228

Health conditions studied

1

Description of health condition studied
Fatigue and sleep quality in hemodialysis patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mental or physical feeling affecting people's functioning
Timepoint
Before the start of the intervention and at the end of the intervention
Method of measurement
Providing Piper s fatigue scale questionnaire to the participants

Secondary outcomes

1

Description
Enjoying a person's sleep with the highest functional level
Timepoint
Before the start and at the end of the intervention
Method of measurement
Providing PSQI questionnaires to people

Intervention groups

1

Description
Patients in the intervention group will receive foot reflexology massage three sessions a week (for 3 weeks) and each session lasts 16 minutes (each foot massage lasts 8 minutes). At this stage, the patient is placed in a semi-sitting position and his sole The reflexologist is placed parallel to the chest, the patient is asked to close his eyes and be in a relaxed position. Then the masseur, who is the same gender as the patient, performs reflex massage on the solar retina and the pineal gland area on the inner upper part of the soles and big toes. In this way, 1 minute of general massage in each leg, 3 minutes of reflex massage in each area in each leg and 1 minute of rest in between.
Category
Rehabilitation

2

Description
For patients in the control group, the sham group will be considered and only simple touch will be done without putting pressure on specific points.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sinai Hospital
Full name of responsible person
Ali Soltani
Street address
Republic Blvd
City
zarand
Province
Kerman
Postal code
7761819595
Phone
+98 34 3342 2600
Email
sina.hospital@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Haft Bagh Alavi square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kmu@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
raheleh rajabi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
emam khomeini street
City
zarand
Province
Kerman
Postal code
7616913555
Phone
+98 34 3342 5400
Email
rahelehr48@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
raheleh rajabi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
emam khomeini street
City
zarand
Province
Kerman
Postal code
7616913555
Phone
+98 34 3342 5400
Email
rahelehr48@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
raheleh rajabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
emam khomeini street
City
zarand
Province
Kerman
Postal code
7616913555
Phone
+98 34 3342 5400
Email
rahelehr48@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
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
Demographic data including age and gender and disease related information
When the data will become available and for how long
Start high-speed access after printing
To whom data/document is available
public
Under which criteria data/document could be used
Statistical analysis and use of questionnaires
From where data/document is obtainable
Applicants for project documentation should send a message to the responsible author, Mrs. Rahela Rajabi, by email r.rajabi@kmu.ac.ir and provide her with a summary of her project along with the demographics and after reading the relevant information. will take
What processes are involved for a request to access data/document
Sending an email of the abstract of the project along with the sampling method and statistical population to the responsible author of the study and approval of the qualification by the responsible author. After the project is completed, it is necessary to provide its details to the responsible author. One month after receiving the email from the project author, the responsible author will provide the necessary information to them.
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