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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01681056
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Nina Kemala Sari, MD, Indonesia University

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date October 3, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Quality of Life [ Time Frame: 30 days ]
Measured by COOP chart
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Quality of Life
Measured by COOP chart
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Serum Cortisol (ng/mL)
    Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.
  • Interleukin-2 (pg/mL)
    Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.
  • Interleukin-6 (pg/mL)
    Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.
  • Interferon Gamma (pg/mL)
    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 lymbic and paralymbic system (amygdala, hyppocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)
    Ratio change from baseline by Magnetic Resonance Spectroscopy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients
Official Title  ICMJE Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Quality of Life for Geriatric Patients.
Intervention  ICMJE Behavioral: Autosuggestion for 30 days
Other Name: Self talk
Study Arms  ICMJE
  • Experimental: Autosuggestion
    Intervention: Behavioral: Autosuggestion for 30 days
  • No Intervention: Standard medical theraphy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2012)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681056
Other Study ID Numbers  ICMJE U1111-1134-1994
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nina Kemala Sari, MD, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nina K Sari, MD Indonesia University
PRS Account Indonesia University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP