Pain Clinical Trial
Official title:
Comparison of Cognitive Function, Balance, Quality of Life, Depression and Daily Living Activities of Geriatric Individuals Living in Home Environment and Nursing Home.
NCT number | NCT04873791 |
Other study ID # | 10156977 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 29, 2016 |
Est. completion date | June 8, 2017 |
Verified date | May 2021 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
In Turkey, 63% of geriatric people who make up approximately 8.3% of the entire population live in their own living environment, 36% live with their children and 1% live in nursing homes. The number of individuals living in nursing homes is increasing as the nuclear family structure becomes more evident. National Social Security programs give special importance to nursing home restructuring and Social Health Policy aims to increase practices related to "aging in place" and "Active and Healthy Ageing" for geriatric individuals. In this context, projects aimed at preventing secondary negative symptoms in aging and supporting the quality aging process are outstanding. The aim of this study is to assess and compare cognitive functions, balance, musculoskeletal pain severity, psychological state, participation level in activities of daily living, and quality of life of geriatric individuals living different environments.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 8, 2017 |
Est. primary completion date | May 23, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 95 Years |
Eligibility | Inclusion Criteria: - Volunteering to research, - Being in the age range of 65-95, - Individuals with no known health problems, caused inactivity. - Adequate cognitive functions (Standardized Mini Mental Test score of 24 and above). - Individuals who do not have musculoskeletal problems that prevent physical activity. - Giving the informed consent. Exclusion Criteria: - Mental retardation - Epileptic history - Those with diseases that cause neurological, orthopedic, and musculoskeletal problems. |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive performance evaluation | Standardized Mini Mental Test (SMMT) was used. It is used for the quantitative evaluation of cognitive performance within the standard neuropsychiatric examination methods. The test is a short, useful, and a standardized method that can be used globally to determine the cognitive level. It is evaluated in 11 items and under 5 main titles and over a total of 30 points. Low score refers to severe cognitive impairment. | 10 minutes after obtaining socio-demographic information (It was done between the 10th and 25th minutes of the assessment) | |
Primary | Pain severity assessment | Visual Analogue Scale (VAS) that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end. | 25 minutes after obtaining socio-demographic information (It was done between the 25th and 30th minutes of the assessment) | |
Primary | Balance assessment | Berg Balance Scale (BDI) was used to measure balance performance in geriatric individuals. It is often used in clinical trials to assess postural control and predict the risk of falls. The test is made difficult by reducing the ground support. This test consists of 14 items and each section is rated between 0 (bad) and 4 (best). The high score indicates the best balance. 0-20 indicates high risk, 21-40 indicates moderate risk and 41-64 indicates low risk. | 30 minutes after obtaining socio-demographic information. After the visual analogue scale evaluation, the geriatric individuals were rested for 5 minutes (It was done between the 35th and 50th minutes of the assessment). | |
Primary | Evaluation of Depression score | Geriatric Depression Scale (GDS) was used. It consists of 30 self-report questions. In the scoring of the scale, 1 point is given to each answer that suggests depression, and 0 is given for the other answers, and the final score is considered as the depression score. A cut off value of 0-10 was defined as the absence of depression, 11-13 as "probable depression," and 14 and above as "definite depression." | 50 minutes after obtaining socio-demographic information (It was done between the 50th and 60th minutes of the assessment). | |
Primary | Activities of daily living | Barthel Index (BI) was used. The Barthel index consists of 10 main items. The items measure feeding, transferring from bed to wheelchair and to and from a toilet, grooming, bathing, walking on a level surface (or propelling a wheelchair if unable to walk), going up and down the stairs, dressing and undressing, controlling bladder and controlling bowel. The total score is between 0 and 100 and scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency and 100 indicate "total" independency. | 60 minutes after obtaining socio-demographic information. After the geriatric depression scale evaluation, the geriatric individuals were rested for 5 minutes. (It was done between the 65th and 70th minutes of the assessment). | |
Primary | Assessment of Quality of life | Short Form 36 (SF-36) was used. It is a scale that has a generic scale feature and provides extensive measurement. It consists of 36 questions under 8 subheadings. Low scores indicate deterioration in the quality of life. | It was completed after 70 minutes obtaining socio-demographic information. | |
Secondary | Body mass index | Body mass index (BMI) is an inexpensive and easy screening method for weight category. It was calculated with person's weight in kilograms divided by the square of height in meters. | After the permission of patients, it was calculated, in the first 10 minutes of assessment. | |
Secondary | Using of walking aids | Whether the participant used a walking aid or not was recorded. | After the permission of patients, it was calculated, in the first 10 minutes of assessment. |
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