Protocol summary

Summary
Dialysis is a treatment for patients with chronic renal failure, which is used to correct water and electrolyte. Fatigue is a common side effect of hemodialysis. Thus, using a non-invasive and non-pharmacological methods to control and reduce fatigue is required. One of these methods is foot reflexology. This study investigated the effects of foot reflexology on fatigue in patients undergoing hemodialysis is performed. 75 dialysis patients were randomly assigned to three groups, placebo and control are divided. Fatigue in all three groups will be measured using the Piper Fatigue Scale. Foot reflexology intervention group during the dialysis, and dialysis will be carried out over an hour of the start time. If the patient is asked to close his eyes and be in a relaxed state. Then after a gentle massage with the thumb on the solar plexus Direct Push enter it each foot for 10 minutes, 3 times a week, for 4 weeks will do. In the placebo group in other parts of the foot massage reflexology points will be measured in the control group will receive routine care during dialysis. Finally, once the fatigue questionnaire will be completed for each of the three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307077821N5
Registration date: 2013-09-10, 1392/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-10, 1392/06/19
Registrant information
Name
Leila Mahasti Jouybari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
jouybari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Golestan University Of Medical Sciences
Expected recruitment start date
2013-04-07, 1392/01/18
Expected recruitment end date
2013-08-12, 1392/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot reflexology on fatigue in hemodialysis patients in North Khorasan, Iran
Public title
Effect of foot reflexology on fatigue in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18 years and over; with kidney disease stage and constantly under hemodialysis; a week 3 times a 4-hour hemodialysis; a minimum of three months of hemodialysis be obtained from Piper fatigue scale score of 4 or more; do not have amputation or ulcer at the site of reflexology is that the feet of the study area. Exclusion criteria: during the study, patients undergoing peritoneal dialysis or a kidney transplant to take place; be deterred from continuing to participate in the study.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University Of Medical Sciences, Gorgan, Iran
Street address
Kilometer 2 Goran-Sari-Golestan University Of Medical Sciences gorgan Golestan Iran, Islamic Republic Of
City
Gorgan
Postal code
49165568
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
35619112273

Health conditions studied

1

Description of health condition studied
fatigue in hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
Fatigue
Timepoint
Before and after the intervention
Method of measurement
Piper Fatigue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Foot reflexology intervention group for 20 minutes (10 minutes for each leg) 3 times a week, for 4 weeks will do.
Category
Treatment - Other

2

Description
Foot massage points in the placebo group in the points other than in the standard locations specified in reflexology for 20 minutes (10 minutes for each leg) 3 times a week, for 4 weeks will do.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali Teaching Hospital
Full name of responsible person
mostafa roshan ravan
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan, Golestan, Iran Golestan Islamic Republic Of Iran,
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Golestan University Of Medical Sciences معاونت تحقیقات و فنا
Full name of responsible person
Dr Mohamad Jafar Golalipour
Street address
Golestan University Of Medical Sciences, ShastKola Gorgan, Iran Gorgan Golestan Islamic Republic Of Iran, 00981714430360
City
Golestan University Of Medical Sciences, ShastKolam Gorgan, Iran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Golestan University Of Medical Sciences معاونت تحقیقات و فنا
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mostafa Roshan Ravan
Position
MSc Student of Critical Care Nursing
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan, Golestan, Iran Gorgan golestan Iran, Islamic Republic Of
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
m.roshanravan32@gmail.com
Web page address
www.Goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Research Center, Golestan University Of Medical Sciences
Full name of responsible person
Dr. Leila Mahasti Jouybari
Position
Research Deputy of Golestan University Of Medical Sciences
Other areas of specialty/work
Street address
Nursing Research Center, Golestan University Of Medical Sciences
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
jouybari@goums.ac.ir
Web page address
www.Goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Golestan University Of Medical Sciences, Gorgan, Iran
Full name of responsible person
Mostafa Roshan Ravan
Position
MSc Student of Critical Care Nursing
Other areas of specialty/work
Street address
Golestan University Of Medical Sciences, Shastkola, Gorgan, Golestan, Iran Gorgan Golestan Iran, Islamic Republic Of
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
m.roshanravan32@gmail.com
Web page address
www.Goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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