Protocol summary

Study aim
This study aims to determine the effectiveness of group memorization on the level of mental health and happiness of elderly patients in the educational centers of North Khorasan in 1396.
Design
clinical trail
Settings and conduct
The present study is a clinical trial and pre-test-post-test with the aim of determining the effectiveness of memorizing on mental health and happiness of elderly in hemodialysis centers. In this research, the total elderly population under hemodialysis was selected as the research population
Participants/Inclusion and exclusion criteria
The researcher was introduced to the haemodialysis centers with a letter from the research deputy of North Khorasan University of Medical Sciences. Conditions for participation in research for samples, aged over 60, having a history of dialysis for more than three months, lack of clinical diagnosis of mental illness in a hospitalized case during haemodialysis, and not receiving antidepressants and substance abuse drugs, lack of participation in psychological groups and desire To enter the study. The elderly participated in the emergence of signs and symptoms of the crisis during the review of the occurrence of life, the absence of three sessions of research and the reluctance of individuals to continue to cooperate with the sample.
Intervention groups
The necessary co-ordination memorandum sessions were held with each group of interventions. The physical environment of the room sessions was chosen at the respective treatment centers and the time was taken out of dialysis patients. The memorable sessions were then held for four weeks at sixty-minute meetings twice a week, according to the Stinson Protocol
Main outcome variables
Mental Health and Happiness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190102042214N1
Registration date: 2019-02-18, 1397/11/29
Registration timing: retrospective

Last update: 2019-02-18, 1397/11/29
Update count: 0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
Aliasghar Shams abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 9483
Email address
dialis.esfarayen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-18, 1396/11/29
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-03-06, 1396/12/15
Trial completion date
2018-03-06, 1396/12/15
Scientific title
Effectiveness of reminiscence on the level of mental health and happiness in elderly patients under haemodialysis
Public title
The effect of reminiscence in mental health in patients under hemodialysis.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conditions for participation in research for samples, aged over 60, having a history of dialysis for more than three months, lack of clinical diagnosis of mental illness in a hospitalized case during haemodialysis, and not receiving antidepressants and substance abuse drugs, lack of participation in psychological groups and desire To enter the study.
Exclusion criteria:
The elderly participated in the emergence of signs and symptoms of the crisis during the review of the occurrence of life, the absence of three sessions of research and the reluctance of individuals to continue to cooperate with the sample.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
According to the type of study, randomization of the subjects in two groups, the list of these individuals was done after coding. At first, thirty items were withdrawn for the intervention group and the remaining thirty were considered for the control group. In this way, the samples were randomly allocated to the groups
Blinding (investigator's opinion)
Single blinded
Blinding description
The names of people in the spss file are coded as encoded.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of north khorasan University of Medical Sciences
Street address
Emam reza ave.
City
Bojnourd
Province
North Khorasan
Postal code
9661764791
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.NKUMS.REC.1396.51

Health conditions studied

1

Description of health condition studied
Patients under hemodialysis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Beck Depression Inventory framework is made up of 29 items of four items (20 items from the previous scale and 9 items revised), which is answered on a six-point Likert Scale. Oxford Happiness Scale A new form (OHQ) for each question is a score of 1 to 6, for each component a score and for the entire test, also a score that indicates the level of happiness of the person. The highest score one person can receive in this questionnaire is 174 and the lowest is 29. Higher scores mean more happiness.
Timepoint
The assessment will be carried out before and after the intervention. After one month, follow up.
Method of measurement
Demographics, general health and happiness questionnaires of Oxford were completed by all individuals and their mean score was considered as the mean of pre-test scores. In order to hold memorization sessions, the necessary coordination was done with each group of interventions. The memorable sessions were then held for four weeks at sixty-minute meetings twice a week, according to the Stinson Protocol. The first meeting began with the introduction of contributors to each other by their own. The researcher also provided information on his work and merits to get closer to the participants, then on the concepts used in each session and the preparation for each session. Meetings were organized with specific topics, and people focused on different items during the recounting of memories in each session. The topics of the memorial sessions are such as childhood memories, the presentation of the memories of the period of education, the talk about the memories of youth and soldiers, the recollection of the memories of the marriage and the birth of children, talking about memories from parents and friends, expressing memories of holidays, travels and experiences. Job was the talk of the special and important events of the past. The sessions were run by a researcher and a dialysis nurse and the facilitator facilitated the group's interaction during the sessions. Patients were encouraged to recall memories and discussions. The people, with the help of the researcher, after the end of each discussion, interpreted and evaluated the material, meaning what they had been doing and merged them with their present life. At the end of each session, the subject of the next meeting was also reminded, and the participants were advised to be prepared for the subject of the next meeting. The last meeting participants talked about their experiences with the group and shared their latest memories about the topics discussed at the previous sessions. Summarizing and providing feedback to the researcher was done on the topics discussed at the previous sessions. At the end of the last session, Goldberg General Health and Oxford Happiness Questionnaires were again completed by the members of the group and their mean score was considered as a post-test score. During this period, care was taken for the control group, but no intervention was performed. At the end of the eighth session in the control group, the questionnaires were completed again and were considered as a post-test score. One month after the end of the sessions, the tools reviewed in the pre-test were completed in both groups.

Secondary outcomes

1

Description
Happiness and mental health score
Timepoint
Before intervention. After intervention. Follow up one month later
Method of measurement
Demographic information questionnaire, Goldberg General Health (GHQ-28) and Oxford Happiness (OHQ) were used for data collection.

Intervention groups

1

Description
Intervention group: Memory sessions based on the Stinson protocol were held sixty-minute meetings twice a week for four weeks.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Bojnourd Educational Center Imam Khomeini Esfarayen Hospital
Full name of responsible person
Ali asghar shamsabadi
Street address
Esfarayen Imam Reza Street Imam Khomeini Therapeutic Training Center
City
Bojnourd
Province
North Khorasan
Postal code
9661764791
Phone
+98 58 3723 9483
Email
dialis.esfarayen@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ali asghar shamsabadi
Street address
Emam reza ave
City
Bojnourd
Province
North Khorasan
Postal code
9661764791
Phone
+98 58 3723 9483
Email
dialis.esfarayen@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Aliasghar shamsabadi
Position
Student of msc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam reza ave
City
Bojnourd
Province
North Khorasan
Postal code
9661764791
Phone
+98 58 3723 9483
Email
dialis.esfarayen@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
aliasghar shamsabadi
Position
msc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
khalij fars Blvd., bojnourd Town
City
bojnourd
Province
North Khorasan
Postal code
9661764791
Phone
+98 58 3723 9483
Email
dialis.esfarayen@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Aliasghar shamsabadi
Position
Msc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam khomeini hospital ,esfareyen town
City
Bojnourd
Province
North Khorasan
Postal code
9661764791
Phone
+98 58 3723 9483
Email
dialis.esfarayen@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
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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