An interventional study of Supportive Psychotherapy in Psychosomatic Disorder, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care
Hypothesis
Research objectives 1.1 General Objectives: To develop non-pharmacologic psychotherapy as part of holistic therapy for acute coronary syndrome patients during their treatment at intensive cardiac care unit.
1.2 Specific Objectives:
Introduction Acute coronary syndrome will have a high impact on who feels it. Psycho-neuro-immunological imbalance will occur before and after the attack. To date, there is no evidence regarding the role of supportive psychotherapy as a non-medical treatment in acute coronary syndromes. The study will also measure cortisol, immunoglobulin-A, serotonin, and heart rate variability for objective comparisons between intervention and usual cardiac care.
Method This research is an operational research with a mixed method research design, namely exploratory sequential method with qualitative method research that precedes quantitative methods. This research is divided into two stages, namely the qualitative research stage by developing a model of supportive psychotherapy, followed by the stage of applying the model to clinical trials of acute coronary syndrome patients during treatment at intensive cardiac care unit.
Result Total subject is 80 subject. All will collect blood and saliva sample, heart rate variability. One arm will do intervention (supportive psychotherapy) and the others will do usual cardiac care.
20 studies on the registry are indexed under Psychophysiologic Disorders; 8 are open to participants now.
This study's enrollment of 80 is below the median of 94 across 14 interventional studies indexed under Psychophysiologic Disorders.
Browse Psychophysiologic Disorders studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Supportive Psychotherapy do to subjects
Behavioral: Supportive Psychotherapy
Do Casual Intervention
Supportive Psychotherapy give to patient with Acute Coronary Syndrome
Changes Visual Analog Scale In Comfort Feeling after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Visual Analog Scale measurement (in numeric scale from 0 to 10)
Time frame: per subject will completed about 12 days. Supportive psychotherapy will do to intervention subject and all subject (wit and without intervention) will ask visual analog scale at day 1, day 5, and day 12.
Changes in blood serotonin levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Serotonin level measurement (ng/dL)
Time frame: All subject will completed about 12 days. The blood sample will check at day 1, day 5, and day 12.
Changes in saliva cortisol levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Cortisol level measurement (ng/dL)
Time frame: All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.
Changes in saliva immunoglobulin-A levels after Superficial Supportive Psychotherapy Model on Acute Coronary Syndrome Patients
Immunoglobulin-A level measurement (ng/dL)
Time frame: All subject will completed about 12 days. The saliva sample will check at day 1, day 5, and day 12.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Sep 2021, 5 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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