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Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients (ESAQoGe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina Kemala Sari, MD, Indonesia University
ClinicalTrials.gov Identifier:
NCT01681056
First received: September 4, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Quality of Life for Geriatric Patients.
 Behavioral: Autosuggestion for 30 days

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Measured by COOP chart


Secondary Outcome Measures:
  • Serum Cortisol (ng/mL) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Ratio change from baseline by Magnetic Resonance Spectroscopy.


Enrollment: 51
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autosuggestion Behavioral: Autosuggestion for 30 days
Other Name: Self talk
No Intervention: Standard medical theraphy

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681056

Locations
Indonesia
Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Nina K Sari, MD University of Indonesia
  More Information

No publications provided

Responsible Party: Nina Kemala Sari, MD, Medical Doctor, Indonesia University
ClinicalTrials.gov Identifier: NCT01681056     History of Changes
Other Study ID Numbers: U1111-1134-1994
Study First Received: September 4, 2012
Last Updated: October 2, 2012
Health Authority: Indonesia: University of Indonesia

Keywords provided by Indonesia University:
autosuggestion
quality of life
geriatric
serum cortisol
 Interferon gamma
interleukin-2
interleukin-6
neuroplasticity

ClinicalTrials.gov processed this record on May 23, 2013