Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress

NCT01513824 | Completed DMC

• 1 other identifier: SongHeart
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Biofeed Back Guided Stress Management; Ischemic Heart Disease

Keywords

stress; biofeed back guided treatment; acupressure; ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Clinical stress signs and quality of life measures

  3 months

Study Arms (2)

stress management, acupressure

ACTIVE COMPARATOR

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

bio feedback guided, stress management

NO INTERVENTION

control without treatment

Interventions

pressure pain sensitivity measure followed bu acupressure BEHAVIORAL

twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.

stress management, acupressure

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Medicine, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24849077 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 20, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

DK (1)