The study will conduct to investigation of acupressure effectiveness on sleep quality in patients with chronic heart failure. In this controlled clinical trail, 60 chronic heart failure patients will select from 22 bahman hospital via convenience sampling, then the subjects randomly allocate to three groups (true acupoint group, pseudo acupoint group and control group). EF has more than 20 and less than 40، absence of any lesion on the shenmen point، no history of acupressure and minimum 40 and maximum 65 years are necessary for including to the study. Unwillingness to continue participation in the study for any reason, patient was unavailable for any reason (death, discharge), drugs for 5 to 6 hours before bedtime will lead to withdrawal from the study sample. Subjects in true acupoint group will receive acupressure in hand shenmen points for three nights, 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 heart unit by a trained practitioner (Project Officer). Pre and post test for measurement of sleep with Sleep Quality Index SMHSQ.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014103019761N1
Registration date:2015-01-10, 1393/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-10, 1393/10/20
Registrant information
Name
Reza Bordbar
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 6423
Email address
bordbarr1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-08-04, 1393/05/13
Expected recruitment end date
2015-01-03, 1393/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acupressure effect on sleep quality in patients with chronic heart failure
Public title
Acupressure effect on sleep quality in patients with chronic heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Patients with systolic heart failure and left ventricular ejection fraction (Ef) is greater than 20 and less than 40%؛ In the absence of any injury at the shenmen point؛ No history of acupressure ؛ Having awareness؛ listening and speaking abilities at an acceptable level to accountability؛ Minimum 40 and maximum 65 years
Exclusion criteria:Unwillingness to continue participation in the study؛ Out of reach of the patient(Death،discharge)؛ Get opium for 5 to 6 hours before bedtime؛ Use sedative drugs
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Sabzevar University of Medical Sciences
Street address
Vice chancellor for research of Sabzevar University of Medical Science, 5th km of Sabzevar to Tehran Road, Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
(medsab.Rec.93.30)
Health conditions studied
1
Description of health condition studied
Sleep
ICD-10 code
F51.2
ICD-10 code description
Nonorganic disorder of the sleep-wake schedule
Primary outcomes
1
Description
sleep quality
Timepoint
Before the intervention- First to fourth day of hospitalization
Method of measurement
SMHSQ Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The third group (control group), a group that receives the usual routine procedures.These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.
Category
Other
2
Description
The second group intervention (The false point): these patients, the second night in hospital the point with 1-1.5 cm distance of shenmen point of bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.
Category
Other
3
Description
Intervention in first group(acupressure): these patients, the second night in hospital shenmen point bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.