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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01513824
First received: January 17, 2012
Last updated: February 25, 2014
Last verified: February 2014
  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


Enrollment: 216
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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:

  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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513824

Locations
Denmark
Department of Medicine, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 25, 2014
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
Heart Diseases
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014