Intervention for CABG to Optimize Patient Experience

Not Applicable

Recruiting

• Conditions: I25.9; I35.9; I05.9; Chronic ischaemic heart disease, unspecified; Aortic valve disorder, unspecified; Mitral valve disease, unspecified

• Registration Number: DRKS00015309
• Lead Sponsor: niversitätsmedizin Göttingen, Klinik für Psychosomatische Medizin und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. end point: changes in health status, time point: baseline to discharge, instrument: EQ-5D-VAS<br>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)<br><br>

Secondary Outcome Measures

Name	Time	Method
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 <br>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)<br>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)<br><br>