Effect of Benson relaxation technique on pain, physical activity, quality of sleep, quality of life, and clinical and biomedical parameter in hemodialysis patients
Hemodialysis patient suffer many problem such as pain, impairment in physical activity, quality of sleep and quality of life. Moreover, some of the changes were happened in their clinical and biomedical parameter. The aim of this study was to determine the effect of Benson relation technique on pain, physical activity, quality of life, quality of sleep and clinical and biomedical parameter in hemodialysis patients. In a randomized controlled trial was carried out in the hemodialysis centers of Shiraz University of Medical sciences. Clinically stable hemodialysis patients (n = 86) were included and followed in two groups: the Benson relaxation technique group (n = 43) and the control group (n = 43). Benson relaxation technique was done in experimental groups for 10-20 min, twice a day for 8 weeks. Physical activity, pain, quality of life, quality of sleep and clinical and biomedical parameter were assessed in both groups at baseline and 8 weeks after intervention. Data were analyzed with two independent and dependent samples t–test, chi–square.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061613690N1
Registration date:2013-07-11, 1392/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-11, 1392/04/20
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical sciences
Expected recruitment start date
2011-02-01, 1389/11/12
Expected recruitment end date
2012-01-09, 1390/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson relaxation technique on pain, physical activity, quality of sleep, quality of life, and clinical and biomedical parameter in hemodialysis patients
Public title
Effect of Benson relaxation technique on pain, physical activity, quality of sleep, quality of life, and clinical and biomedical parameter in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study were being 18 years old or above, being on HD twice a week or more for at least the previous 3 months, and being alerted and oriented. On the other hand, the patients having unstable hypertension and angina, arrhythmia, congestive heart failure, acute cerebrovascular accident, hepatic failure, physical limitation for learning and performing the relaxation technique, and prior training or current use of relaxation therapy were excluded from the study. The patients with emotional upheaval during the previous month were excluded, as well. The reason for these exclusions was that these complications might affect the concentration which is important in the relaxation technique and these patients might have difficulty in performing this procedure.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
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
shiraz university of medical sciences
Street address
71345-1978, 7th floor, shiraz university of medical sciences, beside the Red-Crescent building, Zand Street, Shiraz,
City
Shiraz
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
(88-4666)
Health conditions studied
1
Description of health condition studied
Renal failure, Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
quality of life
Timepoint
firt day of study and 8th week
Method of measurement
Fereance and Powers quality of life index, Dialysis version
Secondary outcomes
1
Description
pain
Timepoint
frist day and 8th week of study
Method of measurement
VAS
2
Description
physical activity
Timepoint
first day and 8th week
Method of measurement
Daily Living Activity (ALD) & IADL
3
Description
sleep
Timepoint
first day and 8th week
Method of measurement
quality of sleep Index
4
Description
Adherence and Biomedical Markers
Timepoint
first day and 8th week
Method of measurement
Biomedical Markers
Intervention groups
1
Description
Relaxation training was performed in separate rooms while the patient was in the bed in supine position. The instruction of BRT lasted for twenty minutes and the subjects needed to: 1) Sit in a comfortable condition, 2) Close their eyes, 3) Completely make all their muscles less tense beginning from the soles of the feet forward up and relax all parts of the body, 4) Breathe through their nose, listen carefully to the sound of their breathing, and when the breath was out, silently say the word 'one' to themselves, for example, breath in . . . out, 'one'; in . . . out, 'one' . . ., and 5) Continue for twenty minutes. The patients were instructed to check the time while opening their eyes; however, alarm did not have to be used.
Category
Behavior
2
Description
Control
The control group received the routine care without any BRT intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee and Shahid Faghihi Hospital of Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Skandari
Street address
71345-1978,7th floor, Shiraz university of medical sciencese, beside the Red-Crescent building, Zand Ave, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
MS, and Candidate of PhD
Other areas of specialty/work
Street address
nursing and midwifery university, Namazee Sque,Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
Rambodm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
MS. Candidate of PhD
Other areas of specialty/work
Street address
nusring and Midwfery of Shiraz University, Namazee Squre, Zand st, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
rambodm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
MS
Other areas of specialty/work
Street address
Nursing and Midwifery university, Znd Ave, Namazee Squ, Shiraz
City
Shraz
Postal code
Phone
+98 71 1647 4258
Fax
+98 71 1647 4252
Email
rambodm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)