Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress (SongHeart)
This study is currently recruiting participants.
Verified January 2012 by Herlev Hospital
Sponsor:
Herlev Hospital
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01513824
First received: January 17, 2012
Last updated: January 23, 2012
Last verified: January 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Biofeed Back Guided Stress Management Ischemic Heart Disease |
Behavioral: pressure pain sensitivity measure followed bu acupressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart) |
Resource links provided by NLM:
Further study details as provided by Herlev Hospital:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: stress management, acupressure
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
twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.
|
|
No Intervention: bio feedback guided, stress management
control without treatment
|
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:
- 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
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513824
Contacts
| Contact: Jens Faber, Professor | +45 38689016 | jenfab01@heh.regionh.dk |
Locations
| Denmark | |
| Department of Medicine, Herlev Hospital | Recruiting |
| Herlev, Denmark, 2730 | |
Sponsors and Collaborators
Herlev Hospital
More Information
No publications provided
| Responsible Party: | Jens Faber, professor, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01513824 History of Changes |
| Other Study ID Numbers: | SongHeart |
| Study First Received: | January 17, 2012 |
| Last Updated: | January 23, 2012 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by Herlev Hospital:
|
stress biofeed back guided treatment acupressure ischemic heart disease |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Ischemia Coronary Disease |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013