Considering the common complaint of Older people with Insomnia, Sleeping Pills side effects and adverse impact that sleep deprivation affects the Physical Health of the Elderly Later, where this method is much less Expensive and Require Specialized personnel and equipment and no special tools and the Elderly can use this method anywhere in the world, This study aimed to determine the effect of Benson Relaxation will be done on sleep Quality in the Elderly. This study is a clinical trial that among all Health Centers in Qazvin 10 centers will be selected randomly. The sample size was estimated 80 people. Seniors eligible for the study available and in the two Intervention groups (n = 40) and Control (n = 40), and will be followed up. Inclusion criteria included an age over 60 years, a sleep disorder on a scale of Pittsburgh Sleep and exclusion criteria of the study in unwillingness to participate in the study, a disease with mental disorders (Schizophrenia, Dementia, Anxiety and Depression), having intellectual disabilities and Chronic diseases including Cancer, taking tranquilizers to sleep and doing drugs are given relaxation training program is incomplete. Benson relaxation in the test group for 20 minutes twice a day for 4 weeks will be done. Sleep disorders in both groups at baseline and 4 weeks will be evaluated using a questionnaire Pittsburgh.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071228891N1
Registration date:2016-11-30, 1395/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-30, 1395/09/10
Registrant information
Name
mitra habibollahpour
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 33696824
Email address
fmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Benson Relaxation Technique on Sleep Quality among the Elderly at Health Center of Qazvin
Public title
The Effect of Benson Relaxation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having Over 60 Years Old, Having a Sleep Disorder based on the Pittsburgh Sleep Scale, Interest in Participating in the Study, Having full Consciousness, Ability Speech and hearing, Having the tools necessary to use the Instruction file, Resident Qazvin City
Exclusion criteria: Unwillingness to Participate in the Study, Having a Mental Illness, Having Intellectual Disabilities and Chronic Diseases, Use Sedatives Except Sleep Aids, Incomplete Carried Taught Relaxation Program, Elder Died or was Admitted to the Hospital During the Study
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Qazvin University Of Medical Sciences
Street address
bahonar Blvd, Integrated campus University of Medical Sciences, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.QUMS.REC.1395.114
Health conditions studied
1
Description of health condition studied
Sleep Disorder
ICD-10 code
G47.2
ICD-10 code description
Disorders of the Sleep-Wake Schedule
Primary outcomes
1
Description
Sleep Disorder
Timepoint
the first day and a month later
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Sleep Disorder
Timepoint
the first day and a month later
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Control Group: The control group received no intervention will not cross.
Category
Behavior
2
Description
In the Intervention group relaxation Techniques for 20 minutes twice daily for 4 weeks will. Benson relaxation instructions will be trained in the following way. 1. Sit in a comfortable position. 2. Close their eyes. 3. Relax all their muscles beginning from the soles of the feet, moving forward up,and relax all parts of their body. 4. Breath through their nose, pay attention to the sound of their breathing and say the word one quietly to themselves when the breath was out. 5. Continue for 20 min. The patients were instructed to check the time by opening their eyes. However using an alarm was prohibited.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Qazvin
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mitra Habibollahpour
Street address
Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mitra Habibollahpour
Position
Masters Student Geriatric Nursing
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin university of Medical Sciences, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3369 6824
Fax
Email
m.habibollahpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Position
PHD Aging
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3333 8034
Fax
Email
fmohammadi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mitra Habibollahpour
Position
Masters Student Geriatric Nursing
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3369 6824
Fax
Email
m.habibollahpour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)