Protocol summary

Summary
Purpose or goals: the effect of massage with hot stones on sleep quality in patients undergoing hemodialysis training center - Taleghani Hospital in 1394 - 1393 as a quasi-experimental study will be carried out this research. Inclusion criteria:patient be male؛ in the case of hemodialysis hospital researchat at least six months ؛ willingness to participate in the study؛ contributing to the lack of any known disease ؛ sleep disorders (respiratory diseases, cancer) except for kidney failure؛ to full consciousness؛ hearing ability ؛ speech acceptable for answering the questions؛ the absence of confirmed previous psychiatric disorders؛ lack of addiction to drugs and alcohol. Exclusion criteria: the death of the patient؛ the patient continued lack of cooperation؛ lack of patient refer to the hospital. 60 samples were determined and were divided into intervention and control groups. Before the start of the first session, the sleep quality of patients in both groups was measured using the Pittsburgh Sleep Quality Index. "The patients in the intervention group after the completion of hemodialysis, massage with hot stones will be in the afternoon. To protect the privacy of patients will use a folding screen. The basalt stones heated in heater to 120-130 degrees Fahrenheit and then the patient lying prone position for 10 minutes in hot stones are placed over the main chakras of the patient. The massage is done for 20 minutes. Lower back and neck massage started continues. Massage therapy three days a week for four weeks, totaling 12 sessions of hemodialysis done after the end of the day after the end of the last session, patients will sleep quality questionnaire to fill out". "For patients in the control group, in the first sleep quality questionnaire completed by patients. Also, after a month without any interference, will also try to fill out the questionnaire". Outcome: sleep quality hemodialysis patients after the use of massage with hot stones treatment will be different between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042922009N1
Registration date: 2015-06-25, 1394/04/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Behnam Abdollahpoor
Name of organization / entity
Urmia Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 44 3635 5051
Email address
abdollahpoor.b@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia Medical Sciences University
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of hot stone massage therapy on hemodialysis patients sleep quality level in Urmia Taleghani therapeutic-educational center in 2015
Public title
The effect of hot stone massage therapy on hemodialysis patients sleep quality level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:patient be male؛ in the case of hemodialysis hospital research؛ willingness to participate in the study؛ contributing to hemodialysis for at least six months؛ lack of any known disease affect sleep disorders (respiratory diseases, cancer) except kidney failure؛ to full consciousness؛ hearing ability and speech acceptable for answering the questions؛ the absence of confirmed previous psychiatric disorders؛ lack of addiction to drugs and alcohol. Exclusion criteria: the death of the patient؛ the patient continued lack of cooperation؛ lack of recurrent patient to the hospital
Age
From 15 years old to 100 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 urmia Medical Sciences University
Street address
Urmia, Resalat bolvard, Quarter emergency
City
urmia
Postal code
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
umsu.rec.1394.17

Health conditions studied

1

Description of health condition studied
hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis

Primary outcomes

1

Description
sleep quality
Timepoint
Before the start of the first session, the day after the last session
Method of measurement
Pittsburgh Sleep Quality

Secondary outcomes

1

Description
sleep disorders
Timepoint
Before the start of the first session, the day after the last session
Method of measurement
Pittsburgh Sleep Quality

Intervention groups

1

Description
60 samples were determined and were divided into intervention and control groups. Before the start of the first session, the sleep quality of patients in both groups was measured using the Pittsburgh Sleep Quality Index. "The patients in the intervention group after the completion of hemodialysis, massage with hot stones will be in the afternoon. To protect the privacy of patients will use a folding screen. The basalt stones heated in heater to 120-130 degrees Fahrenheit and then the patient lying prone position for 10 minutes in hot stones are placed over the main chakras of the patient. The massage is done for 20 minutes. Lower back and neck massage started continues. Massage therapy three days a week for four weeks, totaling 12 sessions of hemodialysis done after the end of the day after the end of the last session, patients will sleep quality questionnaire to fill out".
Category
Other

2

Description
"For patients in the control group, in the first sleep quality questionnaire completed by patients. Also, after a month without any interference, will also try to fill out the questionnaire".
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Taleghani Hospital
Full name of responsible person
Behnam Abdollahpoor
Street address
Urmia, Kashani Avenue
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, urmia medical sciences university
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia, Resalat Mission, Quarter Emergency
City
Urmia
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, urmia medical sciences university
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
Urmia Medical Sciences University
Full name of responsible person
Behnam Abdollahpoor
Position
Graduate Student
Other areas of specialty/work
Street address
Urmia, Resalat Bolvard, Quareter Emergency
City
Khoy
Postal code
Phone
+98 44 3635 5051
Fax
Email
behnam.abdollahpoor@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Medical Sciences University
Full name of responsible person
Shamsadin Shams
Position
Master of Science
Other areas of specialty/work
Street address
Urmia, Resalat Bolvard, Quareter Emergency
City
Urmia
Postal code
Phone
+98 44 3223 4897
Fax
Email
shamsadin1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Behnam Abdollahpoor
Position
Graduate Student
Other areas of specialty/work
Street address
City
Postal code
5817648557
Phone
+98 44 3635 5051
Fax
Email
Web page address

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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