Protocol summary

Summary
This study is a clinical trial that evaluates the effects of acupressure on sleep quality in hemodialysis patients. A total of 48 chronic hemodialysis patients over 18 years in dialysis departments of education hospitals, including Ahvaz Golestan Hospital, who their scores based on Pittsburgh questionnaire, were 5 or more were studied. The patients were randomly assigned into intervention or control group. Acupressure interventions in four weeks and three times per week for 15 minutes were performed for the patients in the intervention group. The patients in the control group only received routine treatment. Sleep quality of patients, based on Pittsburgh questionnaire, was assessed before the treatment and one week after the end of the treatment and compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904144321N1
Registration date: 2010-12-01, 1389/09/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Mohsen Hoshmand
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 3943
Email address
mohsenhoshmand@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Ahvaz Jondishapour University
Expected recruitment start date
2010-05-23, 1389/03/02
Expected recruitment end date
2010-05-30, 1389/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on sleep quality in hemodialysis patient
Public title
The effect of acupressure on sleep status of patients undergoing long-term hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ESRD patients who complain of sleep disturbance, age 18–65 years, Patients undergoing maintenance hemodialysis for at least three months, no upper or lower extremities amputation, stable mental status with no dementia, ability to communicate Exclusion criteria: dialysis complications which require immediate intervention, presence of debilitating physical or mental illness and other diseases that compromise the ability to answer the questions, presence of major chronic diseases such as cancer or lupus erythematosus, presence of diabetic neuropathy, transfer the patient to intensive care units, surgery, infection, or bleeding during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz jundishapur University of Medical Sciences
Street address
Golestan Boulevard
City
Ahvaz
Postal code
Approval date
2010-09-25, 1389/07/03
Ethics committee reference number
2926

Health conditions studied

1

Description of health condition studied
end- stage renal disease
ICD-10 code
N18.0
ICD-10 code description

Primary outcomes

1

Description
sleep quality
Timepoint
One week before and after completion of the intervention Acupressure
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acupressure intervention for 4 weeks, 3 sessions per week for 15 minutes
Category
Treatment - Other

2

Description
Control group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Abdolali Shariati
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Office of Ahvaz Jondishapour University
Full name of responsible person
Mostafa Ferghhi
Street address
Central Library, Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Office of Ahvaz Jondishapour 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, Ahvaz Jundishapur Univercity of Medical Sciences ,
Full name of responsible person
Mohsen Hoshmand
Position
Master Nursing Student
Other areas of specialty/work
Street address
Faculty of Nursing, Ahvaz Jundishapur University of Medical Sciences ,
City
Ahvaz
Postal code
Phone
+98 210372355487
Fax
Email
cesare_20@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abdolali Shariati
Position
MS Nursing Education
Other areas of specialty/work
Street address
Ahvaz Jundishapur Univercity of Medical Sciences ,Nursing College
City
Ahvaz
Postal code
Phone
+98 21 6313 4412
Fax
Email
shsh_ali2003@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing, Ahvaz Jundishapur Univercity of Medical Sciences ,
Full name of responsible person
Abdloali Shariati
Position
MS Nursing Education
Other areas of specialty/work
Street address
Faculty of Nursing, Ahvaz Jundishapur Univercity of Medical Sciences
City
Ahvaz
Postal code
Phone
Fax
Email
shsh_ali2003@yahoo.com
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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