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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06180694
Other study ID # amasyau-mçy-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date May 4, 2024

Study information

Verified date January 2024
Source Amasya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is seen that the use of reminiscence therapy, which is an important non-pharmacological treatment that is used quite frequently in the management of dementia in the world, is not at the desired level in our country, and the studies conducted are mostly interview-based. This research will be carried out with the aim of determining the effect of reminiscence therapy applied to individuals with dementia on cognitive functions, anxiety, depression and activities of daily living. In this study, reminiscence therapy will not be based only on interviews, but a separate activity program that will trigger specific recall/memory for each interview will be included, taking into account the socio-cultural structure in the therapy process. The research will be conducted in Amasya Suluova Hacı Muammer Koca Nursing Home Elderly Care and Rehabilitation Center, with a pre-test post-test single group, quasi-experimental research design. The sample of the research will consist of 28 participants diagnosed with dementia (mild/moderate), aged 65 and over. In this research, reminiscence therapies will be carried out once a week for 8 weeks, in sessions of approximately 45 minutes. Research data will be collected between January and March 2024 using the Standardized Mini Mental Test, Geriatric Anxiety Scale, Geriatric Depression Scale and Katz's Activities of Daily Living Index. Data collection forms will be applied twice in total, at the end of the 1st session (pretest) and at the end of the 8th session (posttest). The data obtained from the research will be analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program. Variables covering the descriptive characteristics of individuals with dementia will be expressed in numbers and percentages. Whether the data has a normal distribution will be determined by the Kolmogrov Smirnov test and parametric and/or nonparametric tests will be used according to the results obtained. Statistical significance value will be accepted as p<.05.


Description:

Dementia; It is a disease that requires intensive use of health services, has a high care burden, and has medical, social, psychological and economic burdens for the patient, family and society. Dementia is characterized by many disorders in cognitive functions, especially memory, thought and social skills. Progressive disorders in cognitive functions cause behavioral changes, decrease in activities of daily living, and neuropsychiatric symptoms such as anxiety and depression. evaluation and management of cognitive problems in individuals with dementia are important because they increase both the burden of care and mortality and morbidity. Various pharmacological and non-pharmacological treatments are used in the management of incurable dementia, and the treatments are mostly aimed at reducing the behavioral and psychological symptoms of the disease. The interest in non-pharmacological treatments has increased due to the moderate effectiveness of pharmacological treatments in the management of dementia, their high level of side effects and limited applicability. One of the popular non-pharmacological treatments used to enhance memory in dementia is reminiscence therapy. In reminiscence therapy, elderly individuals are provided to recall their past experiences, these experiences are talked about, and positive emotions are shared individually or in a group.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date May 4, 2024
Est. primary completion date April 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Being diagnosed with mild to moderate dementia according to DSM-5 criteria (whether individuals have an official diagnosis of neurocognitive disorder according to DSM-5 criteria and their medical diagnosis will be verified from the health records at the institution), - Getting a score between 13-23 for the educated (literate) and 10-23 for the uneducated (illiterate) on the mini mental state examination, - Being 65 years of age or older, - Being able to communicate, - No vision or hearing problems, - Consent to participate in the research. Exclusion Criteria: - Getting a score below 13 and above 23 for the educated (literate) and below 10 and above 23 for the uneducated (illiterate) from the mini mental state examination, - Having an acute illness that prevents participation in intervention sessions, - Having serious sensory and physical limitations that prevent participation, - Having severe neuropsychiatric symptoms (agitation, psychosis, apathy, uncontrolled delirium, etc.), - Having a traumatic life history, - Having recently participated in a similar program.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reminiscence therapy
In the research, reminiscence therapies will be carried out once a week for 8 weeks, in sessions of approximately 45 minutes.

Locations

Country Name City State
Turkey Merve Çayir Yilmaz Amasya

Sponsors (2)

Lead Sponsor Collaborator
Amasya University The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Cognitive Status on the Standardized Mini Mental Test (SMMT) at Week 8 SMMT, which allows assessing cognitive status, is the most frequently used and easily applied test in dementia screening. The scale is evaluated out of 30 points in total. For SMMT, scores of 23/24 are considered the cutoff score for dementia, but traditionally scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment, between 18 and 23 points is considered mild dementia, between 13 and 17 points is considered moderate dementia, and below 12 points is considered severe dementia. Change = (Week 8 Score-Baseline Score) Baseline and week 8
Primary Change from Baseline in Anxiety Symptoms on Geriatric Anxiety Scale (GAS) GAS,developed for the elderly, is a 30-item scale that has somatic, cognitive and affective subscales and monitors anxiety symptoms. The total score on the scale varies between 0-75. A high score indicates a high level of anxiety.Change = (Week 8 Score-Baseline Score) Baseline and week 8
Primary Change from Baseline in Depressive Symptoms on Geriatric Depression Scale Short Form (GDS-SF) GDS-SF, is a scale consisting of 15 questions that questions the emotional state of elderly individuals. The cut-off point of the scale is 7 points and above. Scores between 0 and 4 indicate no depressive symptoms, scores between 5 and 8 indicate mild depressive symptoms, scores between 9 and 11 indicate moderate depressive symptoms, and scores of 12 and above indicate severe depressive symptoms. Change = (Week 8 Score-Baseline Score) Baseline and week 8
Primary Change from Baseline in Patient's Dependency on Basic Self-Care Behaviors on Katz's Activities of Daily Living Index (KADLI) KADLI, evaluates the patient's dependence on basic self-care behaviors that are required to live and are expected to do every day. The scale evaluates the degree of dependency in basic daily living activity parameters, including information on bathing, dressing, toileting, transfer, continence and nutrition. Scoring of the index ranges from 0 to 6, and a patient with a score of 6 is considered independent, and a patient with a score of 0 is considered fully dependent. Change = (Week 8 Score-Baseline Score) Baseline and week 8
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