Completed

NCT Number: NCT01681056

Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

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.

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Key information

Conditions

Quality of Life for Geriatric Patients.

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autosuggestion for 30 days

Behavioral

Other names: Self talk

Primary outcomes

Quality of Life

Time frame: 30 days

Measured by COOP chart

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Acronym: ESAQoGe

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Sep 7, 2012
Registry last updated: Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.