- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681056
Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients (ESAQoGe)
Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion
The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life.
The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. Autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and control groups received usual standard medical therapy.
Baseline data were collected within one week after admission. Then the subject will be followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2, interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system by Magnetic Resonance Spectroscopy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 10430
- Dr. Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: ≥ 60 years old with multipathology, inpatients
- Not in steroid therapy
- Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)
- Cooperative
- Willing to go through all of the research steps.
Exclusion Criteria:
- Stroke
- Multiple Sclerosis
- Brain Tumour
- Using Pace maker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Autosuggestion
|
Other Names:
|
NO_INTERVENTION: Standard medical theraphy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 30 days
|
Measured by COOP chart
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Cortisol (ng/mL)
Time Frame: 30 days
|
Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00
am.
|
30 days
|
Interleukin-2 (pg/mL)
Time Frame: 30 days
|
Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00
am.
|
30 days
|
Interleukin-6 (pg/mL)
Time Frame: 30 days
|
Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00
am.
|
30 days
|
Interferon Gamma (pg/mL)
Time Frame: 30 days
|
Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00
am.
|
30 days
|
N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)
Time Frame: 30 days
|
Ratio change from baseline by Magnetic Resonance Spectroscopy.
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina K Sari, MD, Indonesia University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1134-1994
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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