Protocol summary

Study aim
Determining the effect of participation in cognitive fun activities on life satisfaction and memory status of the elderly
Design
.Randomized clinical trial with control group, on 80 elderly people
Settings and conduct
The study population is 80 elderly people living in Kahrizak sanatorium in Alborz province. After obtaining a research permit from the ethics committee of the School of Nursing, Midwifery and Rehabilitation, the researcher will introduce himself to the Kahrizak Alborz Charity Center and select 80 elderly people who meet the criteria to enter the research from the list of elderly people living there.
Participants/Inclusion and exclusion criteria
1. No cognitive impairment by AMT tool (score below 6 indicates cognitive impairment.)2. History of living in a nursing home for 6 months 3.No mental problems based on medical records and the opinion of the psychiatrist. 4. Lack of experience of grief or acute emotional problems in the last 6 months according to the ward psychologist 5. The ability of sight and hearing and speech to communicate 6.The elderly in the age range of 60 to 90 years
Intervention groups
Playing puzzles and word formation with letters for 12 weeks on individual days for 1 hour in the research environment and the elderly in groups of 2 to 3 people will be held in the form of lectures, questions and answers and discussions.
Main outcome variables
Life satisfaction level and memory status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210302050557N1
Registration date: 2021-07-15, 1400/04/24
Registration timing: retrospective

Last update: 2021-07-15, 1400/04/24
Update count: 0
Registration date
2021-07-15, 1400/04/24
Registrant information
Name
Tahere Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3620 5446
Email address
tahereahmadi.1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-22, 1400/02/02
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participation in cognitive leisure activities on life satisfaction and memory status in the elderly
Public title
The effect of participation in cognitive leisure activities on life satisfaction and memory status in the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly in the age range of 60 to 90 years No cognitive impairment by AMT tool (score below 6 indicates cognitive impairment.) History of living in a nursing home for 6 months No mental problems based on medical records and the opinion of the psychiatrist 5. Lack of experience of grief or acute emotional problems in the last 6 months according to the ward psychologist 6. The ability of sight and hearing and speech to communicate
Exclusion criteria:
Having an acute illness during study Hospitalization and non-participation in the program for 2 consecutive sessions Personal reasons for leaving the study
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are classified by random sampling method, based on age and gender, are divided into two groups of test and control (40 people in each group, 20 men and 20 women). The method of random allocation will be classified in such a way that the elderly will be divided into two groups based on their gender, men and women, and then each group will be divided into three age groups: ages 60-69, 70-79 and 80+. According to the two sex groups and the three age groups, we will have a total of six classes. Random allocation for the control and intervention group will be done in a simple random manner in each of these six classes and random allocation will be done using SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are aware of the participation, drawbacks and benefits of this study. After filling informed consent form, The participants and their families will be blind toward randomized allocation. Moreover, the researcher and the one who collects and analyzes the data will be blind too.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 1, Poursina St, Qods St, Enghelab St
City
Tehran
Province
Tehran
Postal code
1415665881
Approval date
2021-04-22, 1400/02/02
Ethics committee reference number
IR.TUMS.FNM.REC.1400.011

Health conditions studied

1

Description of health condition studied
Life satisfaction and memory status
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Life satisfaction
Timepoint
Before the intervention, after the intervention and 3 months after the intervention
Method of measurement
Elderly Life Satisfaction Questionnaire (LSI)

2

Description
Memory status
Timepoint
Before the intervention, after the intervention and 3 months after the intervention
Method of measurement
Wechsler memory test

Secondary outcomes

empty

Intervention groups

1

Description
The intervention includes performing cognitive puzzle fun activities and word formation with letters, which will be performed for 30 months on individual days for 1 hour, each intervention for 30 minutes.
Category
Prevention

2

Description
Control group: People in the control group do not receive any intervention and are placed on a waiting list to be rehearsed at another time.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kahrizak Charity Institution of Alborz Province
Full name of responsible person
Dr. Afshin Vejdani Roshan
Street address
Saheb Al-Zaman Street
City
Mohammad Shahr
Province
Alborz
Postal code
31845167
Phone
+98 26 3630 9171
Email
pr@kahrizakcharity.com
Web page address
https://kahrizakcharity.com/kahrizak-charity-hospital-in-alborz-province

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamadali Sahraian
Street address
6th Floor, Central Building, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3334
Email
vcr@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
Tahere Ahmadi
Position
Master degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Hadith Alley 4, Tabatabai St., Meshkin Dasht, Karaj
City
Tehran
Province
Tehran
Postal code
3177959374
Phone
+98 26 3620 5446
Email
tahereahmadi.1375@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahere ahmadi
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Hadith Alley 4, Tabatabai St., Meshkin Dasht, Karaj
City
Karaj
Province
Alborz
Postal code
3177959374
Phone
+98 26 3620 5446
Email
Tahereahmadi.1375@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahere ahmadi
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Hadith Alley 4, Tabatabai St., Meshkin Dasht, Karaj
City
karaj
Province
Alborz
Postal code
3177959374
Phone
+98 26 3620 5446
Email
Tahereahmadi.1375@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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