Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress (SongHeart)
Primary Purpose
Biofeed Back Guided Stress Management, Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
pressure pain sensitivity measure followed bu acupressure
Sponsored by
About this trial
This is an interventional treatment trial for Biofeed Back Guided Stress Management focused on measuring stress, biofeed back guided treatment, acupressure, ischemic heart disease
Eligibility 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
Sites / Locations
- Department of Medicine, Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
stress management, acupressure
bio feedback guided, stress management
Arm Description
bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months
control without treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01513824
Brief Title
Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress
Acronym
SongHeart
Official Title
Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biofeed Back Guided Stress Management, Ischemic Heart Disease
Keywords
stress, biofeed back guided treatment, acupressure, ischemic heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stress management, acupressure
Arm Type
Active Comparator
Arm Description
bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months
Arm Title
bio feedback guided, stress management
Arm Type
No Intervention
Arm Description
control without treatment
Intervention Type
Behavioral
Intervention Name(s)
pressure pain sensitivity measure followed bu acupressure
Intervention Description
twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.
Primary Outcome Measure Information:
Title
MDI depression score
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical stress signs and quality of life measures
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Medicine, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24849077
Citation
Bergmann N, Ballegaard S, Bech P, Hjalmarson A, Krogh J, Gyntelberg F, Faber J. The effect of daily self-measurement of pressure pain sensitivity followed by acupressure on depression and quality of life versus treatment as usual in ischemic heart disease: a randomized clinical trial. PLoS One. 2014 May 21;9(5):e97553. doi: 10.1371/journal.pone.0097553. eCollection 2014.
Results Reference
derived
Learn more about this trial
Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress
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