Determining the Effect of Therapeutic Reality on Death Elderly Anxiety (General Objective)
Design
Clinical trials with community-based control group with parallel groups have not been blinded. Two-step randomized, first step: selecting cluster randomized cluster-managed nursing homes. Second stage: Selection of elderly people eligible for Simple random method
Sample size: 44 people
Settings and conduct
The place of research is nursing homes covered by Shemiran's well-being.
At first, random cluster sampling of 5 elderly homes was selected from nursing homes of well-being and then entered into each cluster of eligible elders and randomly divided into two groups of intervention and control. The sample number is 44 people. Then, the demographic questionnaire and death anxiety for the elderly are completed. Then, real-life therapy is delivered as a lecture for 8 sessions, every 2 weeks for each session, 90 minutes for each session. During this period, the control group will receive no training. After completing the meetings, the Templer questionnaire will be completed again for both groups.
Participants/Inclusion and exclusion criteria
Entry requirements :
1- To receive a score of 8 to the Templar death anxiety questionnaire
2. Be alert and able to speak Persian.
3. No severe physical and psychological illness.
4. Hearing problems.
5. Miles to participate in research.
Non-arrival conditions:
Earning a score below 8 from Templar's Death Anxiety Inventory
Intervention groups
Intervention group: Reality Therapy Education
Control group: no training.
Main outcome variables
By the difference of the points obtained before and after the education of the reality of the treatment, the effect of training will be determined.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042237N1
Registration date:2019-01-17, 1397/10/27
Registration timing:registered_while_recruiting
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
Monir Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 5194
Email address
monir20ghaffari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of therapeutic reality on the anxiety of the death of the elderly
Public title
The Effect of Therapeutic Reality on Death Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert and able to speak Persian.
Severe physical and emotional illness.
Do not have hearing problems.
Willing to participate in research.
Exclusion criteria:
Co-operative in another psychotherapy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
At first, five houses are selected randomly from nursing homes, then clustered, elderly eligible and randomly assigned to two groups of intervention and control.
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, Islamic Azad University of Medical Sciences, Tehran, Iran
Street address
No.8;11 Alley; Aasgari Street; Shahran
City
Tehran
Province
Tehran
Postal code
1478739557
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.IAU.TMU.REC.1396.316
Health conditions studied
1
Description of health condition studied
Death Anexity
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
People who have a Templar death anxiety score above 8.
Timepoint
Death anxiety measurement before and after intervention
Method of measurement
Templer death anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the purpose of the study is explained and then two demographic and Templar death anxiety questionnaires will be completed by the researcher for the elderly. Then the treatment of reality therapy will be delivered as a lecture for the intervention group for 8 sessions, 2 sessions per week each 90 minutes each session. . These sessions are guided by the principles of the theory of therapeutic reality so that the initial sessions of the members are familiar with each other and the rules of the training course and the statement of the objectives of the sessions are emphasized.In the following sessions, the outline of the theory of therapeutic reality, including life in the present, basic human needs, accountability, successful work, planning to achieve the goals and behavioral techniques is taught. After completing the sessions, the Templer questionnaire will be completed for individuals, and the impact of training will be determined by differentiating the scores obtained before and after the reality therapy.
Category
Behavior
2
Description
Control group: First, the purpose of the study is explained and then two demographic and Temple death anxiety questionnaires are completed for the subjects. This group does not receive any training. After 4 weeks, the Templer questionnaire will be completed again and the results will be reviewed by the intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shemiranat Welfare
Full name of responsible person
Naji Yalali
Street address
Rashid Yasemi Street; Valiaasr Avenu
City
Tehran
Province
Tehran
Postal code
1968713111
Phone
+98 21 8877 8052
Fax
+98 21 8877 4135
Email
pr@behzisti.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Research Associate, Faculty of Nursing, Azad University of Tehran (Dr. Nekavand )
Street address
Zargande Street; Shariaati Street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
iautmu@iautmu.ac.ir
Web page address
http://www.iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Shirin Hejazi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zargande Street; Shariaati Street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
iautmu@iautmu.ac.ir
Web page address
http://www.iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Hejazi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zargande Street; Shariaati Street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
iautmu@iautmu.ac.ir
Web page address
http://iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Monir Ghaffari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zargande Street; Shariaati Street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
iautmu@iautmu.ac.ir
Web page address
http://www.iautmu.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After being unidentified, information about the Death Anxiety Score and the impact of education can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Just in order to know the result of the research
From where data/document is obtainable
Tehran, Shariati St., Zargandeh St., Tehran, Islamic Azad University of Medical Sciences, Tehran, Iran.
1-library, Mr. Ismaili
2- Send an email to the research director, Ms. Hejazi
Postal code: 1916893813
Mailbox: 19395/1495
Phone: 22006660
Email: iautmu@iautmu.ac.ir
What processes are involved for a request to access data/document
1- Referral to the library unit of Islamic Azad University of Medical Sciences of Tehran
2- Send an email to the research director, Ms. Hejazi