Biofeed Back Guided Stress Management, Ischemic Heart Disease
Conditions
Keywords
stress, biofeed back guided treatment, acupressure, ischemic heart disease
Brief 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
Interventions
BEHAVIORALpressure pain sensitivity measure followed bu acupressure
twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDI depression score | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical stress signs and quality of life measures | 3 months | 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 |
Countries
Denmark
Outcome results
None listed