C34 C92.0 C91.0
Conditions
Interventions
Group 1: Virtual Reality Group:
Each patient in the VR group will receive two different VR experiences in a daily changing VR environment every day from Monday to Friday. During the intervention patie
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adult patients capable of consent who are receiving inpatient chemotherapy for lung cancer or acute myeloid or acute lymphatic leukemia.
Exclusion criteria
Exclusion criteria: Non-consenting patients; minor patients; pregnant patients; patients admitted as emergencies; patients participating in another intervention study that may have a potential impact on the endpoints of this study; Patients with infectious disease and need for isolation, pre-existing dementia, schizophrenia, hallucinations, panic attacks, or epileptic seizures; pacemaker or defibrillator wearers; patients taking neuroleptics or antiepileptic drugs; patients with active alcohol and/or drug abuse; lack of proficiency in 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. - 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 two study groups. Score and standard deviation in the quality of life questionnaire are compared between both study groups. - Difference in number and severity of side effects and complications from chemotherapy between the two study groups - Difference in length of hospital stay between the two study groups - Difference in patient satisfaction between the two study groups | — |
Countries
Germany
Outcome results
None listed