Protocol summary

Summary
The purpose of this study was to evaluate and compare the impact of warm water foot bath, effleurage massage and petrissage massage on fatigue and sleep quality of Patients undergoing Hemodialysis. In this quasi-experimental study, eligible patients by non-random sampling selected, but according to randomly blocked among the three intervention groups warm water foot bath, effleurage massage and petrissage massage were divided. There was not control group. In finally, 62 hemodialysis patients were enrolled from two centers in Yasuj. The main inclusion criteria: at least 6 months of hemodialysis treatment; the more fatigue score; sleep quality score 5 or more and exclusion criteria: renal transplantation; migration and death. Three intervention groups separately trained and performed in hemodialysis ward warm water foot bath and massages for two weeks, three times a week. After ensuring the correct implementation, interventions continued by patients in home for two months, every night an hour before sleep. In the footbath group, the feet was immersed 15 minutes in the water 41 to 42 ° C. In effleurage massage was performed steady and long movement on the back, shoulders and neck and in petrissage massage kneading movement on the shoulders, neck and arms for 15 minutes. One month and two months after intervention, fatigue and sleep questionnaire was completed by patients. The mean score of fatigue and sleep between the three groups and each group was compared before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031021425N1
Registration date: 2016-01-28, 1394/11/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-28, 1394/11/08
Registrant information
Name
Shekoofeh Hamzehiekia
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 7251
Email address
sh.hamzhiekia@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Yasuj University of Medical Science
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-15, 1393/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of warm-water footbath, effleurage massage and petrissage massage on the fatigue and sleep quality of Hemodialysis Patients
Public title
Effect of warm water and massage on the blood dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least 6 months of hemodialysis treatment; the more fatigue score; sleep quality score 5 or more. Exclusion criteria: renal transplantation; migration; death.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
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
Ethics Committee of Yasuj University of Medical Science
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
93050003

Health conditions studied

1

Description of health condition studied
hemodialysis
ICD-10 code
Z99. 2
ICD-10 code description
Dependence on renal dialysis

Primary outcomes

1

Description
fatigue
Timepoint
Two weeks before intervention, one month and two months after from start intervention
Method of measurement
Multidimensional Fatigue Inventory

2

Description
sleep
Timepoint
Two weeks before intervention, one month and two months after from start intervention
Method of measurement
Pittsburgh Quality Sleep Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group of Warm water foot bath: The patient's feet are placed in a basin containing water 41 to 42 ° C to a depth of 10 cm above the ankle for 15 minutes
Category
Rehabilitation

2

Description
Intervention group of effleurage massage: fingers and palms of both hands placed on the patient's lower back and was motion to spine, around spine, back, shoulders and neck and opposite from neck to lower back
Category
Rehabilitation

3

Description
Intervention group of petrissage massage: with fingers and thumb of both hands, shoulders, neck and arms of muscles were catch, brought up, squeezed and then left
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Shekoofeh Hamzheekia
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj

2

Recruitment center
Name of recruitment center
Shahid Rajai Hospital
Full name of responsible person
Shekoofeh Hamzheekia
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Yasuj University of Medical Science
Full name of responsible person
Mahmood Naraki
Street address
Vice Chancellor for Research of Yasuj University of Medical Science, ground floor, Center Building of Yasuj University of Medical Sience, Setad, Shahid Motahari Boulevard, Yasuj.
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Yasuj University of Medical Science
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
Yasuj university of Medical Science
Full name of responsible person
Shekoofeh Hamzheekia
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 1333 7370
Email
Hamzeieki@yahoo.com
Web page address
www.yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr. Ardashir Afrasyabifar
Position
PHD in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 3223 4115
Fax
+98 74 1333 7370
Email
afrasiabifar@yahoo.com- afrasiabifar.ardashir@Yums.ac.ir
Web page address
www.yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Shekoofeh Hamzheekia
Position
Master of Medical Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, second floor, Yasuj University of Medical Science, next to Emam Sajad Hospital, Shahid Jalil boulevard, Yasuj.
City
Yasuj
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 1333 7370
Email
hamzeieki@yahoo.com
Web page address
www.yums.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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