The aim of the present study is to determine the effect of reflexology massage on sleep quality in hemodialysis patients. The study population is all hemodialysis patients who refereed to hemodialysis center of Qazvin Bou-Ali hospital. 62 patients were randomly divided into control and intervention groups. Randomization in this study was conducted using a random numbers table. This study will implement in Bou-Ali Hospital Dialysis Center. The main inclusion criteria include having sleeping disorders and at least 3 months of dialysis. At first, demographic information of patients in both intervention and control groups will be recorded. Patients will asked do not use another treatment for their sleep disorder and also do not perform
activities that affect sleep, such as exercise, yoga refrain during the study. In these patients, massage therapy will be done between dialysis sessions, three days a week (from 6 am to 8 pm) for 4 weeks totally 12 sessions of 30 minutes (15 minutes per leg) by trained colleagues.
Massage of male patients will be done by male nurse and massage of female patients will be done by female nurse. Initial assessment of sleep quality will be measure at baseline, after the first, second, third weeks and final assessment of sleep quality will takes place after 12 sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122125642N1
Registration date:2016-02-15, 1394/11/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-15, 1394/11/26
Registrant information
Name
Ramin Farrokhian
Name of organization / entity
Nursing and Midwifery School, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 2218
Email address
r.farrokhian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of foot reflexology massage on sleep quality in hemodialysis patients
Public title
Foot massage impact on sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Sleep disorders; Having willingness to cooperate in the study and signed an informed consent form; Having at least 3 months of dialysis; Lack of skin disease with involvement; Lack of acute infection; Lack of blood coagulation disorders (because of the risk of blood clots and thromboembolic); No history of drugs and tranquilizers; as well as having no history of psychological problems; No smoking and drugs; The use of other accessories and complementary therapies.
Exclusion Criteria:
The reluctance of patients to continue working during the study; Death of a spouse, close relatives; Referral for transplantation.
Age
No age limit
Gender
Both
Phase
2-3
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
In this study randomization was conducted using a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
Qazvin
Postal code
3419759811
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.QUMS.REC.1394.240
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
Renal fail
ICD-10 code description
Acute renal failure with tubular necrosis
Primary outcomes
1
Description
History of hemodialysis
Timepoint
Before Intervention
Method of measurement
The initial questionnaire, having a history of dialysis three months
2
Description
Sleep Qulality
Timepoint
Before and after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, massage therapy will be done between dialysis sessions, three days a week (from 6 am to 8 pm) for 4 weeks totally 12 sessions of 30 minutes (15 minutes per leg) by trained colleagues.
Massage of male patients will be done by male nurse and massage of female patients will be done by female nurse. Initial assessment of sleep quality will be measure at baseline, after the first, second, third weeks and final assessment of sleep quality will takes place after 12 sessions.
Category
Rehabilitation
2
Description
Control group: There is no intervention in this group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis center of Qazvin Bou-Ali hospital
Full name of responsible person
Ms. Rostami
Street address
Dialysis center, Bou-Ali hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Zinat Joorabchi
Street address
Nursing and Midwifery School, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Zinat Joorabchi
Street address
Nursing and Midwifery School, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
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
Qazvin University of Medical Sciences
Full name of responsible person
Ramin Farrokhian
Position
M.Sc. in Critical Care Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery School, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
raminfarrokhian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ramin Farrokhian
Position
M.Sc. in Critical Care Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery School, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
raminfarrokhian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ramin Farrokhian
Position
M.Sc. in Critical Care Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery School, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
raminfarrokhian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)