UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039368 |
|---|---|
| Receipt number | R000044860 |
| Scientific Title | The Effect of spiritual reminiscence therapy on Depression and hope in life in the elderly |
| Date of disclosure of the study information | 2020/02/02 |
| Last modified on | 2020/02/02 22:10:18 |
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Basic information
Public title
The Effect of spiritual reminiscence therapy on elderly
Acronym
spiritual reminiscence therapy and elderly
Scientific Title
The Effect of spiritual reminiscence therapy on Depression and hope in life in the elderly
Scientific Title:Acronym
Effect of spiritual reminiscence therapy on Depression and hope in life
Region
| Asia(except Japan) |
Condition
Condition
Patients are selected on the basis of include and exclude criteria and after obtaining informed consent, four randomly assigned quadruple blocks are assigned to two groups B and A. For this method, with the Statistical counselor assistance , a table consist of 156 letters B and A is provided, and then each of these letters is enclosed in a sealed envelope to hide Random assignment, then closing each envelope. It will be numbered in order of the original table. After choosing the appropriated elder, the envelope is opened to the elder and according to the inside letter, the person is assigned to each groups.
Classification by specialty
| Psychiatry | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
determine of spiritual reminiscence therapy on Depression and hope in life in the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression
hope in life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: In this group, after completing demographic form, depression questionnaires (GDS) and Schneider's hop of life questionnaire, spiritual reminiscence therapy will be done in 6 week sessions for 60 to 90 minutes. After the end of sessions, questionnaires will be completed again.
Interventions/Control_2
Control group: Only demographic form, depression questionnaire (GDS) and Schneider's hop of life questionnaire will be completed before and after the intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
60-80 years, cognitive health function assessed by the (BACT) Cognitive Screening Tool , verbal communication ability , no addiction to alcohol and drugs.
Key exclusion criteria
Acute illness and hospitalization and absence in more than one session of six sessions of spiritual reminiscence therapy
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Ali |
| Middle name | |
| Last name | Abbasi |
Organization
Shahroud University of Medical Sciences
Division name
School of Nursing and Midwifery
Zip code
36147-73947
Address
7th Sq, Shahroud, Iran.
TEL
00982332393811
abbsi_msn@yahoo.com
Public contact
Name of contact person
| 1st name | Ali |
| Middle name | |
| Last name | Abbasi |
Organization
Shahroud University of Medical Sciences
Division name
School of Nursing and Midwifery
Zip code
36147-73947
Address
7th Sq, Shahroud, Iran.
TEL
00982332393811
Homepage URL
http://shmu.ac.ir/fa
abbsi_msn@yahoo.com
Sponsor or person
Institute
Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahroud University of Medical Sciences
Address
7th Sq, Shahroud, Iran.
Tel
0098 23 32393811
abbsi_msn@yahoo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 02 | Day |
Last modified on
| 2020 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044860
