N80
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age over 18. - Severe pain reported in clinical routine (minimum of 5 points on NRS scale). - Willingness not to schedule surgery or start a new analgesic (non-opioid and opioid analgesics) during participation in the study (except for established emergency medication). - Willingness not to start a new non-drug treatment such as acupuncture, behavioral therapy, massage. If such therapy exists, it should be continued unchanged - Signed patient information and consent form - Understanding of the German language, ability to consent and compliance - The patient has understood the principle of the patient diary and agrees to keep it according to the instructions and to use the VR glasses according to the instructions.
Exclusion criteria
Exclusion criteria: - Start of regular use of opioid analgesics within 7 days prior to study entry. - Serious mental illness (e.g., psychosis, schizophrenia, bipolar disorder), major depression, screening using the questionnaires, DASS (determining the likelihood of the presence of a depressive disorder or anxiety disorder. - Epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average pain intensity during the day and the maximum pain intensity during the day measured by the NRS scale from 0-10 Daily, throughout the entire study period (14 week of intervention): Daily record (the average pain intensity, max. pain intensity, on- demand medication), using the pain e-diary | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain-related impairment as measured by the PDI score improves by 20% 2. Improvement in general health-related quality of life measured by the SF 12 3. Sleep quality improves as measured by the MOS-SS | — |
Countries
Germany
Contacts
Department für Frauengesundheit