Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients (ESAQoGe)
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|ClinicalTrials.gov Identifier: NCT01681056|
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : October 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life for Geriatric Patients.||Behavioral: Autosuggestion for 30 days||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||February 2012|
Behavioral: Autosuggestion for 30 days
Other Name: Self talk
|No Intervention: Standard medical theraphy|
- Quality of Life [ Time Frame: 30 days ]Measured by COOP chart
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681056
|Dr. Cipto Mangunkusumo Hospital|
|Jakarta, DKI Jakarta, Indonesia, 10430|
|Principal Investigator:||Nina K Sari, MD||Indonesia University|