ESAQoGe: Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT01681056

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autosuggestion	Behavioral: Autosuggestion for 30 days Other Names: Self talk
No Intervention: Standard medical theraphy

Arm

Intervention/Treatment

Experimental: Autosuggestion

Behavioral: Autosuggestion for 30 days

Other Names:

Self talk

No Intervention: Standard medical theraphy

Outcome Measures

Primary Outcome Measures

Quality of Life [30 days]
Measured by COOP chart

Secondary Outcome Measures

Serum Cortisol (ng/mL) [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) [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) [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) [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) [30 days]
Ratio change from baseline by Magnetic Resonance Spectroscopy.