The purpose of this study is to determine the effect of back massage therapy by slow stroke procedure on Fatigue score in hemodilysis patients. This study is a randomized controlled trial. Participants will be 56 patients undergoing hemodilysis in Bou-Ali hospital in Ardebil. The main inclusion criteria is having medical record in Bou-Ali hospital in Ardebil and the main exclusion criteria is the fatigue score below 3 according to piper fatigue scale. First all the patients fill the fatigue scale. Then patients with fatigue score over 3, after giving conscious consent, will be divided into control or intervention group. Intervention group will receive massage therapy 3 days each week for 4 weeks. Control group will receive no specific intervention. 15 days and 4 weeks later, fatigue scale will be filled again by intervention group and 4 weeks later by control group. Fatigue scores will be compared between 2 groups and before and after intervention in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211046801N2
Registration date:2012-12-14, 1391/09/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-14, 1391/09/24
Registrant information
Name
Hadi Hassankhani
Name of organization / entity
Tabriz university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0364
Email address
hassankhanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of slow stroke back massage on hemodialysis patient fatigue
Public title
Effect of massage therapy on hemodialysis patient fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Dialysis patient who have medical documentary in dialysis ward and experience hemodialysis at least 3 months. Exclusion criteria: Fatigue score below 3.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of medical sciences ethics committee
Street address
nursing and midwifery faculty of Tabriz
City
Tabriz
Postal code
51745347
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91123
Health conditions studied
1
Description of health condition studied
fatigue in hemodialysis patient
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Fatigue score
Timepoint
Once before intervention and again 15 days and 4weeks after intervention
Method of measurement
According to piper fatigue scale
Secondary outcomes
empty
Intervention groups
1
Description
In this study intervention group will receive slow stroke back massage 3 days each week for 1 month and every time for 10 minutes in hours between 15-19
Category
Rehabilitation
2
Description
control group will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Hospital of Ardabil
Full name of responsible person
Mina Nahamin - Msn student of care
Street address
Bouali Hospital, Saheli street
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Dr Sakineh Mohammad Alizadeh
Street address
Nursing and Midwifery faculty, south Shariati S.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of medical sciences
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
Tabriz University of medical sciences
Full name of responsible person
Dr Hadi Hassankhani
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, south Shariati St.
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
hassankhanih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Dr Hadi Hassankhani
Position
Nursing PhD
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, south Shariaty St.
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
hassankhanih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mina Nahamin
Position
MS student of nursing
Other areas of specialty/work
Street address
Nursing and Midwifery faculty of Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
mina.nahamin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)