Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress
Condition: Biofeed Back Guided Stress Management; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      The purpose of the study is to examine if bio feedback guided stress management by daily
      measurement of pressure pain sensitivity followed by acupressure reduces signs of depression
      and number clinical stress signs and increases quality of life in patients with stable,
      ischemic heart disease
    

Detailed description: 
      Primary outcome Measure:

      MDI depression score (time frame 3 months) (designated as safety issue: no) The effect of 3
      months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure
      of the actual stress level followed by stress management of which Acupressure is mandatory

      Secondary outcome measures:

        1. Clinical stress signs and quality of life measures (time frame 3 months) (designated as
           safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain
           Sensitivity on the chest bone as a measure of the actual stress level followed by stress
           management of which Acupressure is mandatory, on a Clinical Stress Signs score (56
           items), SF-36 and WHO-5 questionnaires

        2. Measure of Pressure Pain Sensitivity by a professional (designated as safety issue: no)
           The effect of 3 months twice daily measurements of pressure pain sensitivity on the
           chest bone as a measure of the actual stress level followed by stress management of
           which acupressure is mandatory

        3. Measures of heart function: Blood pressure, the Pressure-Pulse Product (heart work),
           Heart Rate Variability inclusive response to Tilting, BNP (time frame 3 months)
           (designated as safety issue: no) The effect of 3 months twice daily measurements of
           Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level
           followed by stress management of which Acupressure is mandatory

        4. Measures of the Metabolic Syndrome: HOMA-1, Adiponectin, HBA1C, Lipids, Body Composition
           (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice
           daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the
           actual stress level followed by stress management of which Acupressure is mandatory

      Tertiary outcome Measures:

      Use of health care (time frame one year after start of intervention) The effect of months
      twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the
      actual stress level followed by stress management of which Acupressure is mandatory, followed
      by 9 months bioguided feedback stress management when needed, i.e. post-study maintenance
      treatment
    

Intervention name(s): pressure pain sensitivity measure followed bu acupressure
Intervention type(s): Behavioral
Intervention description(s): twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: stress; biofeed back guided treatment; acupressure; ischemic heart disease