This controlled clinical trial and double blind study will conduct to determine the effectiveness of acupressure on sleep quality and anxiety in hemodialysis patients. 75 hemodialysis patients will select from Bushehr hospitals via convenience sampling, then the subjects will allocate into three groups (intervention, placebo and control group) by using stratified random allocation. At least six mounts history of hemodialysis and greater than five score in Pittsburgh Sleep Quality Index, ages from 18 to 65 years, are necessary for including to the study. Subjects in intervention group will receive acupressure in true acupoint (hand Shenmen, PC6 and Yintang points) three times a week for one month, placebo group will experience massage in pseudo points with about 1 to 1.5 cm distance near to the true points (hand Shenmen acupoints) and no intervention will do in control group. Intervention will be take place in hemodialysis unit by two trained practitioners. Pretest and posttest for measurement of sleep and anxiety will do by using Pittsburgh Sleep Quality Index, Sleep Log and Spielberger State Trait Anxiety Inventory (STAI).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061717237N3
Registration date:2014-09-17, 1393/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Golestan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on sleep quality and anxiety in hemodialysis patients
Public title
The effect of Acupressure on sleep quality and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age from 18 to 65 years; at least 6 months history of hemodialysis; three times hemodialysis in a week and four hours for each session; five or greater score in Pittsburgh Sleep Quality Index; having complete alertness, hearing and speech ability; having the ability to read and write; not having developing a psychiatric disorders which lead to consumption of psychiatric drugs; cancer; lupus erythematosus; dermatological disease; advanced heart failure; stroke;amputation; sore, infection or fistula in acupoints; Carpal Tunnel Syndrome (CTS).
Exclusion criteria: Patient hospitalization in intensive care unit, consumption of psychiatric drugs and distortion in mental status, death during intervention; the incidence of severe stressful event such as the death of someone close; not wanting to continue participation; travel; surgery and transplants lead to exclusion of subjects from the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization strategies:
Considering sleep quality level, patients were allocated to three matched intervention, placebo and control groups. Allocation will be achieved using stratified random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
562089303181
Health conditions studied
1
Description of health condition studied
Chronic Renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5 (on dialysis)
Primary outcomes
1
Description
Quality of sleep
Timepoint
Before intervention and a week after four weeks intervention
Method of measurement
Pittsburgh Sleep Quality Index and Sleep Log
Secondary outcomes
1
Description
Anxiety
Timepoint
Before intervention and a week after four weeks intervention
Method of measurement
State Trait Anxiety Inventory (STAI)
Intervention groups
1
Description
Intervention group: Acupressure will be done on true acupoints (hand Shenmen, PC6 and Yintang) by using 3 to 4 kg pressure, with the practitioners' thumb in a period of two revolutions per second.The intervention will conduct three times a week for a month.
Category
Other
2
Description
Placebo group: Massage will done in pseudo points with about 1 to 1.5 cm distance near to the true acupoints three times a week for a month.
Category
Other
3
Description
Control group: Without any intervention.
During the study, If any intervention is required to modifying patients' anxiety and sleep disturbance, they will be excluded from study.