C18 C19 C20
Conditions
Interventions
Group 1: On weekdays, each participant in the VR Fitness Group is offered one 30-minute session of activity-promoting VR fitness game per day from the first post-operative day until discharge. The ses
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who are between 18 and 75 years of age, are capable of informed consent and are not under legal guardianship, are undergoing abdominal surgery for colorectal carcinoma or liver metastases of colorectal carcinoma, and provide written informed consent.
Exclusion criteria
Exclusion criteria: Non-consenting patients, underage patients, pregnant patients, and patients participating in another intervention study that may have a potential impact on the endpoints of this study will be excluded from participation. Other exclusion criteria include a history of dementia, schizophrenia, hallucinations, panic attacks, or epileptic seizures in the medical history. Wearers of pacemakers or defibrillators as well as patients taking neuroleptics or antiepileptic drugs will be excluded from the study. Patients with active alcohol and/or drug abuse will also be excluded from the study. Other exclusion criteria are: Heart failure NYHA = 3, COPD = Gold 3, myocardial infarction within the last 3 months, untreated cardiac or pulmonary disease, and musculoskeletal conditions that limit age-appropriate range of motion of the upper body, arms, shoulders, and neck.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Because this study is a pilot study, it is not designed to test a specific hypothesis. Therefore, a distinction was made between feasibility endpoints and clinical endpoints. Feasibility endpoints: - Participation, recruitment, and retention rates. Participation rate is the proportion of participants who meet inclusion criteria and agree to participate in the study. Recruitment rate is the number of participants recruited per month. Retention rate is the number of participants who completed the total number of planned interventions. - Proportion of interventions actually completed relative to planned interventions for each participant. - Rate of discontinued interventions and reasons for discontinuation. - Compliance regarding the patient's response to the questionnaires. Compliance with regard to completion of questionnaires is the proportion of Completed questionnaires at the specified dates. - Deviations from the study protocol. Number of deviations from the study protocol (e.g., interventions not performed or performed differently than described in the study protocol, questionnaires not distributed or not completed) and reason for deviation from the study protocol (patient-related, personnel-related, organizational). | — |
Secondary
| Measure | Time frame |
|---|---|
| Because this study is a pilot study, it is not designed to test a specific hypothesis. Therefore, a distinction was made between feasibility endpoints and clinical endpoints. Clinical endpoints: - Difference in health status surveyed with the EQ-5D-5L health questionnaire preoperatively, 7 days after surgery, and 30 days after surgery. - Difference in number and severity of postoperative complications between study groups - Difference in length of hospital stay between the two Study groups - Difference in psychosocial distress preoperatively, at 7 days, and at 30 days, assessed with the NCCN Distress Thermometer - Difference in patient satisfaction at discharge | — |
Countries
Germany
Outcome results
None listed