Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

Quality of Life for Geriatric Patients. Clinical Trial

— ESAQoGe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681056
• Other study ID #: U1111-1134-1994
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: October 2, 2012
• Start date: August 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: University of Indonesia
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Quality of Life for Geriatric Patients.

Intervention

Behavioral:
• Autosuggestion for 30 days

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Measured by COOP chart	30 days	No
Secondary	Serum Cortisol (ng/mL)	Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.	30 days	No
Secondary	Interleukin-2 (pg/mL)	Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.	30 days	No
Secondary	Interleukin-6 (pg/mL)	Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.	30 days	No
Secondary	Interferon Gamma (pg/mL)	Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.	30 days	No
Secondary	N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)	Ratio change from baseline by Magnetic Resonance Spectroscopy.	30 days	No