This randomized control clinical trial will be conducted on 80 hemodialysis patients between 18 to 65 years of age in Imam Khomaini and fatemeh zahra hospitals in sari, Mazandaran Province/ Iran. This study is planned to evaluate the effect of Benson relaxation on stress in hemodialysis patients. the trail will be performed in 80 patients between 18 to 65 years of age Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 2 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease
Exclusion criteria: Patient dissatisfaction; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Age less than 18 and more than 65 years; Use of sedative or anti-anxiety drugs to relief stress.
After approving of the study by sciences vice chancellor of Mazandaran University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 40 patients in experimental and 40 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. No intervention will be made in control group. Hemodialysis stress scale questionnaire (HSS) will complete by all patients before and one month after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108217264N1
Registration date:2011-09-24, 1390/07/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-24, 1390/07/02
Registrant information
Name
Ali Mahdavi
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7342
Email address
a.mahdavi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research chancellor of Mazandaran University of Medical Science
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of benson relaxation on stress in hemodialysis patients
Public title
Effect of benson relaxation on stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 2 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease
Exclusion criteria: Patient dissatisfaction; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Age less than 18 and more than 65 years; Use of sedative or anti-anxiety drugs to relief stress.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research vice Chancellor of Mazandaran University of Medical Science and Health Services
Street address
Moalem square, Moalem street
City
Sari
Postal code
4816715793
Approval date
2011-07-03, 1390/04/12
Ethics committee reference number
90-49
Health conditions studied
1
Description of health condition studied
End stage renal failure(Hemodialysis)
ICD-10 code
N18.9
ICD-10 code description
End stage renal failure(Hemodialysis)N18.9
Primary outcomes
1
Description
Stress in hemodialysis patients
Timepoint
Before and one month after intervention
Method of measurement
Hemodialysis stress scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
After approving of the study by sciences vice chancellor of Mazandaran University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 40 patients in experimental and 40 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. Hemodialysis stress scale questionnaire (HSS) will complete by experimental group before and one month after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
Category
Behavior
2
Description
After approving of the study by sciences vice chancellor of Mazandaran University of medical sciences and completing of written consent form by all participants in the study, patients will be divided randomly into two equal groups: 40 patients in experimental and 40 in control group.NO intervention in control group. Hemodialysis stress scale questionnaire (HSS) will complete by control group before and one month after that. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ehteramosadat Ilali
Street address
Nasibeh Nursing and Midwifery school, Vesal Street, Amir Mazandarani Bulevard
City
Sari
2
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Ehteramosadat Ilali
Street address
Mazandaran University of Medical Science-Nursing, Nasibeh nursing and midwifery school, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice chancellor of Mazandaran University of Medical Science and Health Services
Full name of responsible person
Dr. Ahmah Ali Enayati
Street address
Moalem street, Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Mazandaran University of Medical Science and Health Services
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
Mazandaran University of Medical Science and Health Services
Full name of responsible person
Yadollah Jannati
Position
PHD. /Member of Faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Amir Mazandarani Bulevard
City
Sari
Postal code
4816715793
Phone
+98 15 1226 8918
Fax
+98 15 1226 8915
Email
jannatiyadolah@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science and Health Srevice
Full name of responsible person
Ehteramosadat Ilali
Position
MSc./Member of Faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Amir Mazandarani Bulevard
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
+98 15 1226 8915
Email
Paradis2082000@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science and Health Services
Full name of responsible person
Ali Mahdavi
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Amir Mazandarani Bulevard