Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

Not Applicable

Completed

• Conditions: Quality of Life for Geriatric Patients.
• Interventions: Behavioral: Autosuggestion for 30 days

• Registration Number: NCT01681056
• Lead Sponsor: Indonesia University

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.

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 Timeline

• Study Start: 2010-08
• Primary Completion: 2011-05
• Study Completion: 2012-02
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autosuggestion	Autosuggestion for 30 days	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	30 days	Measured by COOP chart

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia