Mood Disturbances Clinical Trial
— VEOfficial title:
The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
| Verified date | July 2020 |
| Source | Cyprus University of Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The mood disturbances that lung cancer patients experience during and after chemotherapy have a debilitating effect on their quality of life. The goal of the proposed project is to develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to combat the adverse psychological/emotional consequences of receiving treatment for cancer. Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | January 20, 2020 |
| Est. primary completion date | January 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients will be included if they had a histopathological diagnosis of cancer (different types are allowed) - were 18 years or older, on active treatment and were receiving care at the hospital as inpatients - Eligible participants will need to be able to speak and understand Greek and they had given written informed consent - Participants should also have a score of >60 on the POMS total mood disturbance scale, a >50 on the Karnofsky Performance Scale Index - a mean of >50 on the Attentional Function Index (AFI) Exclusion Criteria: - Patients were excluded if they were receiving palliative care - they had an impaired cognitive ability or - they had an impaired visual ability |
| Country | Name | City | State |
|---|---|---|---|
| Cyprus | American Medical Centre | Nicosia |
| Lead Sponsor | Collaborator |
|---|---|
| Cyprus University of Technology | University of Cyprus |
Cyprus,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Mood Disturbances as measured by the POMS | The POMS total mood disturbance comprises subscales that evaluate anxiety, depression, anger, vigor, fatigue, and confusion. The possible range of scores for the TMDS is -40 through 192 with higher scores indicating greater mood. Lower scores indicate an improvement in mood | Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days | |
| Secondary | Changes in Quality of Life as measured by FACT-G | FACT-G, is a self-report instrument consisting of 27-items | Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days | |
| Secondary | Changes in Blood Pressure | Measurement of Blood Pressure | Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days | |
| Secondary | Changes in Heart Rate | Measurement of Heart Rate | Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days |