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

January 17, 2012
February 25, 2014
November 2011
February 2014   (final data collection date for 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
Same as current
Complete list of historical versions of study NCT01513824 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress
Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Biofeed Back Guided Stress Management
  • Ischemic Heart Disease
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.
  • Active Comparator: stress management, acupressure
    bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months
    Intervention: Behavioral: pressure pain sensitivity measure followed bu acupressure
  • No Intervention: bio feedback guided, stress management
    control without treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01513824
SongHeart
Yes
Jens Faber, Herlev Hospital
Herlev Hospital
Not Provided
Not Provided
Herlev Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP