C18 C19 C20 C78.7
Conditions
Interventions
Group 1: Virtual Reality Group:
Each patient in the VR group will receive two different VR relaxation exercises every day from Monday to Friday. Two sessions are held each day (morning and evening). T
Sponsors
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients of who are of legal age and able to give consent undergoing surgery due to colorectal cancer or liver metastases from colorectal cancer
Exclusion criteria
Exclusion criteria: Non-consentable patients; underage patients; pregnant patients; patients admitted as an emergency; patients participating in another clinical study that may have an impact on the endpoints of this study; previously known dementia, schizophrenia, hallucinations, panic attacks or epileptic seizures; patients with pacemakers or defibrillator devices; patients taking neuroleptics or antiepileptics; patients with active alcohol and / or drug abuse; lack of knowledge of German or English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Since this study is a feasibility study, it is not intended to test a specific hypothesis. We therefore distinguish between feasibility outcomes and clinical outcomes Feasibility Endpoints: - Participation, recruitment and retention rates. Participation rate is the proportion of participants providing consent of those who meet the inclusion criteria. Recruitment rate is the number of participants recruited per month. Retention rate is the number of participants who complete the full number of planned interventions. - Intervention adherence. Adherence is the proportion of planned interventions that have been completed by each participant - Patient compliance with completion of questionnaires. Compliance with completion of questionnaires is the proportion of completed questionnaires at the prespecified dates - Adverse events. The frequency (number of participants and number of cases) and nature (e.g. dizziness, vertigo, motion sickness) and severity will be recorded. - Deviations from study protocol. Number of deviations from study protocol (such as skipped interventions) and reason for deviation from study protocol (patient- related, staff-related, organisational). | — |
Secondary
| Measure | Time frame |
|---|---|
| Since this study is a feasibility study, it is not intended to test a specific hypothesis. We therefore distinguish between feasibility outcomes and clinical outcomes. Clinical outcomes Change of mood and wellbeing before and after intervention. - Change of vital signs such as heart rate, breathing rate, blood pressure before and after the intervention. Heart rate, breathing rate, blood pressure is measured manually before and after each intervention. - Difference in change of vital signs between the music and VR-group. Changes in vital signs before and after the intervention will be compared between the music and the VR-group - Change in quality of life during the hospital stay. Quality of life is measured at predefined dates for each patient. Score and standard deviation in the quality of life questionnaire, as well as the score and standard deviation in all subscales, in particular emotional functioning, sleep, and fatigue are compared. - Difference in quality of life between the three study groups. Score and standard deviation in the quality of life questionnaire are compared between all three study groups. - Difference in number and severity of surgical complications between the three study groups - Difference in length of hospital stay between the three study groups | — |
Countries
Germany
Contacts
Public ContactMatthias Anthuber
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Augsburg
Outcome results
None listed