The research was conducted to evaluate the effect of foot reflexology on fatigue and sleep quality in haemodialysis patients. The sample consisted of 70 patients in total, 35 intervention and 35 control patients, receiving treatment in the haemodialysis units of two institutions in birjand(shaikh hadi hadavi & vali asr hospital). Patients included in the research were 18years old or older; had full consciousness and orientation; did not have any communication problems; received haemodialysis three times a week; had been receiving haemodialysis for at least 6 months and agreement to participate in the study.Patients with current skin problems,deep vein thrombosis ,peripheral neuropathy and transfer to intensive care units with any reason, were excluded from the study. reflexology application was performed by a researcher who received a certificate after completing a 50 h theoretical and applied education. Data were collected by using two questionnaire, Fatigue Severity Scale (FSS) and pittsburgh sleep quality index(PSQI) for measuring the severity of fatigue and sleep disorders. The intervention group received reflexology treatment for 3 week in three sessions following haemodialysis and The control group only received routine care. Foot reflexology was chosen, since all patients had fistula arms. Reflexology was applied for16 min in total, 8 min for each foot. Parametric and nonparametric tests were used in data analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100530150N1
Registration date:2016-11-15, 1395/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Mahdi Hadavi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3256 0418
Email address
mahdihadavi.526@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on fatigue & quality of sleep in Birjand heamodialysis patients.
Public title
Reflexology & nursing care
Purpose
Supportive
Inclusion/Exclusion criteria
Patients included in the research were 18 years old or older; the minimum of literacy was elementary; had full consciousness and orientation;did not have any communication problems; received haemodialysis three times a week; had been receiving haemodialysis for at least 6 months; marked the level of severity of fatigue according to FSS scale; marked Pittsburgh Sleep Quality Index (PSQI) scores of five points or over; do not use of any drugs for sleeping; do not participate in relaxation & meditation period and volunteered to participate in the research. Patients with open foot wound, deep vein thrombosis, peripheral neuropathy, kidney transplantation, transfer to intensive care units with any reason, current skin problems, traveling to other city, experience of stressful condition and disagreement to continue were excluded from the study.
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Shahid Qhaffari street
City
Birjand
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.BUMS.REC.1395.69
Health conditions studied
1
Description of health condition studied
Haemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention, after intervention & one week after it
Method of measurement
Pittsburgh sleep quality index(PSQI)
2
Description
Fatigue
Timepoint
Before intervention, after intervention & one week after it
Method of measurement
The FSS scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after the intervention
Method of measurement
Useing piezometer, manual
2
Description
Sufficiency of dialysis
Timepoint
Before and after the intervention
Method of measurement
Using formula
3
Description
Hb
Timepoint
Before and after the intervention
Method of measurement
Laboratory test
4
Description
Hct
Timepoint
Before and after the intervention
Method of measurement
Laboratory test
Intervention groups
1
Description
foot reflexology in intervention group in solar plexus and locale of pineal node for 16 minutes in both legs was conducted.
Category
Other
2
Description
The control group only received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The ward of heamodialysis, Shaikh Hadi Hadavi
Full name of responsible person
Mahdi Hadavi
Street address
The ward of heamodialysis, Shaikh Hadi Hadavi, Taleghani square
City
Qaen
2
Recruitment center
Name of recruitment center
Haemodialysis ward of Vali Asr hospital
Full name of responsible person
Mahdi Hadavi
Street address
Vali Asr hospital, Shahid Ghafari street
City
Qaen
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholam Reza Sharif Zadeh
Street address
Birjand University of Medical Sciences
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mahdi Hadavi
Position
MSc student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Qhafari street
City
Qaen
Postal code
Phone
+98 56 3256 0418
Fax
Email
mahdihadavi.526@bums.ac.ir; nurseicu.61@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahdi Hadavi
Position
MSc student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Qhafari street
City
Qaen
Postal code
9764133898
Phone
+98 56 3256 0418
Fax
Email
mahdihadavi.526@bums.ac.ir; nurseicu.61@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
birjand university of medical science
Full name of responsible person
Mahdi Hadavi
Position
MSc student of Nursing
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Qhafari street
City
Qaen
Postal code
9764133898
Phone
+98 56 3256 0418
Fax
Email
mahdihadavi.526@bums.ac.ir; nurseicu.61@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)