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Intervention for CABG to Optimize Patient Experience

Intervention for CABG to Optimize Patient Experience - I-COPE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015309
Enrollment
90
Registered
2018-08-24
Start date
2019-01-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25.9 I35.9 I05.9

Interventions

Group 1: Standard medical care (coronary artery bypass graft surgery, partly in combination with valve replacement, inpatient treatment approx. 7-10 days) Group 2: psychological intervention on the e

Sponsors

Universitätsmedizin Göttingen, Klinik für Psychosomatische Medizin und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - minimum age 18 years - elective CABG-surgery - sufficient knowledge of German - written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: - previous open heart surgery - no confirmed coronary heart disease - insuffcient knowledge of German, aphasia or other inability to understand the informed consent form or self-assessment questionnaires - active psychosis, addicition (exept tobacco), dementia, major depressive episode, acute suicidality - lack of consent to participate in the study or lack of compliance - malignent tumor, if not treated curative or free of recurrence - conditions that limit the capacity of consent - blindness or conditions that disable the use of VR-glasses - deafness or conditions that disable the use of headphones and ear protection - patients in study arm 3, who do not tolerate the narrowness of the light arch in the test before surgery will be excluded from the study as long as they have not received the light intervention

Design outcomes

Primary

MeasureTime frame
1. end point: changes in health status, time point: baseline to discharge, instrument: EQ-5D-VAS 2. end point: statisfaction with treatment, time point: discharge and follow-up (6 months), instrument: rating skale 1-5 (intervention groups compared with each other and with control group)

Secondary

MeasureTime frame
1. End point: changes in biomarkers, time point: pre-post-follw-up course (IL-6, IL-8, Telomerase), melatonin secretion post-op (2 measures per 24 hours on 3 days), instrument: lab analysis 2. end point: changes in psychometric measures, time point: pre-post-follw-up course, instruments: standardised slef-assessment questionanires (HADS, SF-12, SAQ, PDI, HAF) 3. end point: sleep quality, time point: pre-post-follw-up course, instrument: visual analog scale (intervention groups compared with each other and with the control group)

Countries

Germany

Contacts

Public ContactStella Fangauf

Universitätsmedizin Göttingen, Klinik für Psychosomatische Medizin und Psychotherapie

stella.fangauf@med.uni-goettingen.de0551-39-8057

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026