The study will conduct to investigation of acupressure effectiveness on sleep quality and quality of Life in hemodialysis Patients. In this controlled clinical trail, 108 hemodialysis patients will select from Emam Reza and Hasheminejad hospitals via convenience sampling, then the subjects randomly allocate to three groups (true acupoint group, pseudo acupoint group and control group). At least six mounts history of hemodialysis and greater than five score in Pittsburgh sleep quality index are necessary for including to the study. Patient hospitalization in intensive care unit, consumption of psychiatric drugs and distortion in mental status lead to exclusion of subjects from the study. Subjects in true acupoint group will receive acupressure in hand shenmen points for one month, three times weekly, placebo acupoint group will experience massage in pseudo points with about 1-1.5 cm distance near to the true points and will not do any intervention in control group. Intervention will be take place in hemodialysis unit by a trained practitioner. Pre and post test for measurement of sleep and life quality will do with Pittsburgh sleep quality index, sleep log and short form quality of life questionnaire (SF-36).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106145864N2
Registration date:2011-08-26, 1390/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-26, 1390/06/04
Registrant information
Name
Ali Reza Shariati
Name of organization / entity
Golestan Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
shariaty@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Golestan Medical Sciences University
Expected recruitment start date
2011-04-10, 1390/01/21
Expected recruitment end date
2011-06-11, 1390/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Acupressure on Sleep Quality and Quality of Life in Hemodialysis Patients
Public title
Acupressure Effectiveness on Quality of Sleep and Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
Age between 18-70 years; At least 6 months history of hemodialysis; Having dossier in hemodialysis center; Three time hemodialysis in week and four hours for each session; Five or greater score in Pittsburgh sleep quality index; Having complete alertness, hearing and speech ability; Having reading and writing ability and ability for sleep chart completion.
Exclusion criteria
Hospitalization in intensive care unit or death during intervention; Developing a psychiatric disorders and consumption of psychiatric drugs; Cancer; Lupus erythematosus; dermatological disease; Advanced heart failure; insulin depended diabetes; stroke; Presence mental or physical disabilities; Amputation or sore in acupoint.
Age
From 17 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan Medical Sciences University
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gogan to Sari Road, Gorgan
City
Gorgan
Postal code
Approval date
2011-04-09, 1390/01/20
Ethics committee reference number
57/35
Health conditions studied
1
Description of health condition studied
Sleep Problems
ICD-10 code
F51.0
ICD-10 code description
Nonorganic Insomnia
2
Description of health condition studied
Chronic Renal Filure
ICD-10 code
N18
ICD-10 code description
Chronic Renal Failure
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Before and After of Intervention
Method of measurement
Pittsburgh Sleep Quality Index and Sleep Log
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and After of Intervention
Method of measurement
Quality of Life Questionnaire (SF-36).
Intervention groups
1
Description
True acupoint group, acupressure in hand shenmen points for one month, three times weekly
Category
Other
2
Description
Placebo acupoint group, massage in pseudo points with about 1-1.5 cm distance near to the true points for one month, three times weekly
Category
Other
3
Description
Control group, without any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
Emam Reza Sq, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Street address
Andisheh St, Tollab St, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Golestan Medical Sciences University
Full name of responsible person
Dr Mohammad Ali Vakili
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th of Gogan to Sari Road, Gorgan
City
Gorgan
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, Golestan 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
Faculty of Nursing and Midwifry
Full name of responsible person
Ali Reza Shariati
Position
Master in Nursing
Other areas of specialty/work
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th of Gorgan to Sari , Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
shariati1382@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan Medical Sciences University
Full name of responsible person
Ali Reza Shariati
Position
Master in Nursing
Other areas of specialty/work
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road , Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
shariati1382@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifry
Full name of responsible person
Ali Reza Shariati
Position
Master in Nursing
Other areas of specialty/work
Street address
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
shariati1382@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)