Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress

Study Overview
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Brief Summary
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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
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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: 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 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 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 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

Official Title
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Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)

Conditions
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Biofeed Back Guided Stress Management, Ischemic Heart Disease

Intervention / Treatment
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* Behavioral: pressure pain sensitivity measure followed bu acupressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented stable, ischemic heart disease who have finished heart rehabilitation according to the National Guidelines > 6 months ago Actual use of aspirin, statins, and blood pressure medication according to the National Guidelines Age < 75 years Increased pressure pain sensitivity ≥60 as a sign of persistent stress Exclusion Criteria: Previous diagnosed and treated psychiatric disease besides depression Other Chronic Disease with known significantly reduced life expectancy (as cancer or severe COPD) Other Chronic Disease with known significantly reduced Quality of Life as COPD, chronic pain conditions (but not diabetes or heart disease) Planned heart operation Changed Medication for the Heart (concerning Angina or Heart Failure) within one month Previous use of the Pressure Pain Sensitivity Device followed by treatment with Acupressure

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stress management, acupressure<br>bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months | Behavioral: pressure pain sensitivity measure followed bu acupressure<br>* twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.<br>|
| No Intervention: bio feedback guided, stress management<br>control without treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDI depression score | 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 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical stress signs and quality of life measures | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, biofeed back guided treatment, acupressure, ischemic heart disease