Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 2:33 AM
Study NCT ID:
NCT01681056
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2012-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001346', 'term': 'Autosuggestion'}], 'ancestors': [{'id': 'D013404', 'term': 'Suggestion'}, {'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '30 days', 'description': 'Measured by COOP chart'}], 'secondaryOutcomes': [{'measure': 'Serum Cortisol (ng/mL)', 'timeFrame': '30 days', 'description': 'Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.'}, {'measure': 'Interleukin-2 (pg/mL)', 'timeFrame': '30 days', 'description': 'Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.'}, {'measure': 'Interleukin-6 (pg/mL)', 'timeFrame': '30 days', 'description': 'Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.'}, {'measure': 'Interferon Gamma (pg/mL)', 'timeFrame': '30 days', 'description': 'Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.'}, {'measure': 'N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)', 'timeFrame': '30 days', 'description': 'Ratio change from baseline by Magnetic Resonance Spectroscopy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autosuggestion', 'quality of life', 'geriatric', 'serum cortisol', 'Interferon gamma', 'interleukin-2', 'interleukin-6', 'neuroplasticity'], 'conditions': ['Quality of Life for Geriatric Patients.']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': '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.\n\nBaseline 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 60 years old with multipathology, inpatients\n* Not in steroid therapy\n* Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)\n* Cooperative\n* Willing to go through all of the research steps.\n\nExclusion Criteria:\n\n* Stroke\n* Multiple Sclerosis\n* Brain Tumour\n* Using Pace maker'}, 'identificationModule': {'nctId': 'NCT01681056', 'acronym': 'ESAQoGe', 'briefTitle': 'Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion', 'orgStudyIdInfo': {'id': 'U1111-1134-1994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autosuggestion', 'interventionNames': ['Behavioral: Autosuggestion for 30 days']}, {'type': 'NO_INTERVENTION', 'label': 'Standard medical theraphy'}], 'interventions': [{'name': 'Autosuggestion for 30 days', 'type': 'BEHAVIORAL', 'otherNames': ['Self talk'], 'armGroupLabels': ['Autosuggestion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Nina K Sari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Nina Kemala Sari, MD', 'investigatorAffiliation': 'Indonesia University'}}}}