Determining the Impact of Life Satisfaction on Caregivers of Elderly People at Home
Design
The clinical trial has a randomized, single-blind control group.
Settings and conduct
Intervention at a sports club in the city center.
Participants/Inclusion and exclusion criteria
Entry requirements
1.Minimum literacy
2.Assign at least 31 hours of daily care per week for at least 3 months
3.Physical ability to attend yoga classes
4.No history of attending yoga classes
5. Minimum age of participants is 18 years and maximum 50 years
Non-arrival conditions
1.Absent more than three sessions of yoga exercises
2. Elderly disease worsens
Intervention groups
The intervention group was divided into two groups: 1 and 2, then the intervention was performed in the experimental group for 4 weeks, three times a week for 90 minutes in a downtown sports club in both intervention groups. The training was conducted on different days of the week. To control the ethics of the study, the control group prepared a training booklet on yoga exercises and exercises and presented to the control group after the end of the study.
Main outcome variables
Feeling satisfied with life in the care of the elderly
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045353N1
Registration date:2019-11-14, 1398/08/23
Registration timing:retrospective
Last update:2019-11-14, 1398/08/23
Update count:0
Registration date
2019-11-14, 1398/08/23
Registrant information
Name
Zahra Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4221 1896
Email address
zkaveh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2018-12-23, 1397/10/02
Actual recruitment start date
2018-11-22, 1397/09/01
Actual recruitment end date
2018-12-23, 1397/10/02
Trial completion date
2019-01-21, 1397/11/01
Scientific title
The effect of yoga exercises on life satisfaction in caregivers of elderly people living at home
Public title
The effect of yoga exercises on life satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum literacy
Assign at least 31 hours of daily care per week for at least 3 months
Physical ability to attend yoga classes
No history of attending yoga classes
Minimum age 18 and up to 50 year
Exclusion criteria:
Absent more than 3 sessions of yoga classes
Elderly disease worsens
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was performed using a random number table. To use the random number table, the framework of the statistical community was first specified. The researcher accidentally started moving from one point in the table to the left of the table. The point selection was done by blindfolding and placing the tip of the pen on the table.Envelopes were given to the participants and the relevant codes were inserted into them, and the study participants were sealed. The envelopes were sealed in such a way that the content was not clear and the participants were given an entry order. Due to the double-digit statistical population, participants were given two-digit codes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, community health center (sampling center) personnel, and individuals who assisted in collecting information about participants were recruited when participants were divided into control and intervention groups. The randomization was unaware .80 envelopes were considered and the relevant codes were inserted and the participants in the study were sealed and the contents were unclear. Participants were given the order of inclusion according to the two-digit statistical population of the two-digit codes given to the participants. . 40 patients in the intervention group and 40 in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing and Midwifery and Faculty of Rehabilitation-Tehran University
Street address
Headquarters of the Ministry of Health and Medical Education,between South Flamak and Zarafshan, Iran Sima Ave,Qods Town (West),Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.TUMS.FNM.REC.1397.147
Health conditions studied
1
Description of health condition studied
Yoga and Feeling satisfied with life in the care of the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Feeling satisfied with life in the care of the elderly
Timepoint
After intervention and 4 weeks after intervention
Method of measurement
Life Satisfaction Questionnaire.Q-LES-Q-SF
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group yoga exercises were performed for 4 weeks, 90 minutes and three times a week by the intervention group.
Category
Lifestyle
2
Description
Control group:This group does not do any intervention, but in the end of intervention, this group will be given a yoga pamphlet.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mustafa Khomeini Community Health Center of Saveh
Full name of responsible person
Rostamkhan
Street address
Shariati Ave. Mustafa Khomeini Community Health Center
City
Saveh
Province
Markazi
Postal code
9177899191
Email
info@savehuns.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Waheq Rahimparvar
Street address
Dr. Mirkhani St. (East Nosrat),Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6694 1669
Email
fnm-researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Kaveh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Saeedi4 Alley,TAleghani9 Ave
City
Saveh
Province
Markazi
Postal code
3918837399
Phone
+98 86 4221 1896
Email
z.kaveh1373@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Kaveh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Saeedi4 Alley,Taleghani 9 Ave
City
Saveh
Province
Markazi
Postal code
3918837399
Phone
+98 86 4221 1896
Email
z.kave1373@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Kaveh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Saeedi4 Alley,Taleghani9 Ave
City
Saveh
Province
Markazi
Postal code
3918837399
Phone
+98 86 4221 1896
Email
z.kaveh1373@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information is available but the names of the participants are not known.
When the data will become available and for how long
Start access period after printing results
To whom data/document is available
For university and non-university students
Under which criteria data/document could be used
No special conditions
From where data/document is obtainable
See Researcher. (Zahra Kaveh)
z.kaveh1373@yahoo.com
What processes are involved for a request to access data/document