The Effectiveness of relaxation exercises on decreasing depression, anxiety and stress in elderly people with type 2 diabetes.
Design
Clinical trial with two groups, control and intervention is.In this study, the sample size is 84 people.The control group is 42 and the intervention group is 42. The researcher examines the variables in the intervention group before and after the relaxation exercises by completing the DASS-21 questionnaire.
In the control group once at the beginning of the study and then six weeks later, the same questionnaire is completed.
Settings and conduct
The illness sampling is carried out in Isfahan Health Center 1 and the method of randomization is block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: volunteering؛ Age 60 and older؛ Type 2 diabetes for at least six months؛ Due to respond to the questionnaire DASS-21 stress, anxiety and depression are mild to moderate.
Non-inclusion criteria: Not having alcohol and drug addiction؛ No use of antidepressants؛ Not having a history of receiving relaxation training؛ Severe diabetes complications
Intervention groups
Intervention group:Elderly patients with type II diabetes with stress, anxiety and depression are mild to moderate.Relaxation exercises are done for six weeks in this group.
control group:Elderly patients with type II diabetes with stress, anxiety and depression are mild to moderate.No relaxation exercises are performed in this group.
Main outcome variables
Stress score; anxiety score; depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190119042409N1
Registration date:2019-04-19, 1398/01/30
Registration timing:retrospective
Last update:2019-04-19, 1398/01/30
Update count:0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
bahareh khajeheyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3438 0025
Email address
bkhajeheyan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-04-14, 1398/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of relaxation exercises on decreasing depression, anxiety and stress in elderly people with type 2 diabetes
Public title
The Effectiveness of relaxation exercises in elderly people with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being volunteer to participate in the study
Age 60 years old and over
Type 2 diabetes for at least six months
Acceptable listening and speaking ability to learn relaxation techniques
The ability to read educational materials or the presence of a family member who agrees to read it for the elderly
Mild to moderate stress, anxiety and depression based on the DASS-21 questionnaire scale
Exclusion criteria:
Severe diabetes complications
Not having alcohol and drug addiction
No use of antidepressants and no known mental illness, including severe depression
Not having a history of receiving relaxation training
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is block Randomization, using four blocks. The elderly people From four urban centers which are covered by Health Center number one in Isfahan, with diabetes type 2 who are eligible to enter the study, are randomly divided into two groups of control and intervention. Next the first elderly person who is eligible to enter the study is determined into control or intervention group by the division according to the following table. The sampling is started from right to left respectively. First in block 3 with the admission of the first elderly person who is eligible to enter the study and according to block 3 tabale, the people are placed according following order: the first in the control group, the second in the intervention group, The third in the control group and the fourth in the intervention group. The next block for sampling is number one. The first person placed in the intervention group, the second in the intervention group too, the third and fourth in the control group. As the same way the sampling is done according to the table and specified block from right to left and based on the division of the control and intervention group to reach the sample size to 84 people.
Arrangement of the blocks are right to left
3 3 3 1 3
2 1 4 3 2
4 3 3 2 1
4 2 4 4 1
2 4 4 3 2
block1 block2 block3 block4 (Blocks table A: Treatment B: Control )
A A B B
A B A B
B A B A
B B A A
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Thirteenth floor block A- Headquarters of the Ministry of Health and Medical Education- Between South Falamak and Zarafshan- Ghods Town (West)- Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SBMU.PHNS.REC.1397.062
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Depression Score
Timepoint
Measurement of depression at the beginning of the study and 6 weeks after the intervention
Method of measurement
DASS-21 questionnaire
2
Description
Anxiety Score
Timepoint
Measurement of Anxiety at the beginning of the study and 6 weeks after the intervention
Method of measurement
DASS-21 questionnaire
3
Description
Stress Score
Timepoint
Measurement of stress at the beginning of the study and 6 weeks after the intervention
Method of measurement
DASS-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Relaxation exercises are taught to the elderly people in 3 sessions by the researcher and then these exercises are practiced twice a day by the elderly people at home for six weeks.
Category
Lifestyle
2
Description
Control group: Relaxation exercises are not done in this group and DASS-21 questionnaire is completed once in the baseline and then 6 weeks after the baseline.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Center No 1
Full name of responsible person
Bahareh Khajeheyan
Street address
Faiz Valley
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3662 1110
Fax
Email
bkhajeheyan@sbmu.ac.ir
Web page address
http://hlth1.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahareh Khajeheyan
Street address
School of Health and Safety- Daneshjoo Boulevard- Shahid Shahriari Square- Yemen street- Shahid Chamran Highway-
City
Tehran
Province
Tehran
Postal code
198353-5511
Phone
+98 21 2243 2040
Email
bkhajeheyan@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahareh khajeheyan
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Faiz Valley
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3438 0025
Email
bkhajeheyan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahareh khajeheyan
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Faiz Valley
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3438 0025
Email
bkhajeheyan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahareh khajeheyan
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Faiz Valley
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3438 0025
Email
bkhajeheyan@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available