Consenting practice for spinal injections Musculoskeletal Diseases Consenting practice for spinal injections
Conditions
Interventions
The study is a non-inferiority, randomised, controlled trial. Two different consent forms to consent patients for their spinal injections are used. One form is the standard practice, based on the risk
again, this is six weeks post operative follow up is currently routine practice.
Participants are randomised between groups when their trial packs are distributed. The packs contain t
these are distributed sequentially.
Sponsors
Taunton & Somerset NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Spinal injection (facet injection, nerve root or caudal/foraminal injection) 2. Day case, elective patient 3. Able to consent (capacity) 4. Age 18 years or older
Exclusion criteria
Exclusion criteria: 1. Patients listed for inpatient procedure 2. Emergency injections 3. Patients who are unable to understand English will be excluded because the questionnaires in this study has not been translated and validated into all other languages. 4. Patients who lose capacity before they receive their injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients withdrawing consent for injections is measured using the patient records at time of injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| State of anxiety is measured using state-trait anxiety inventory (STAI) scores at time of reading consent form and day of surgery. | — |
Countries
United Kingdom
Contacts
Public ContactJames;Paul Fletcher;Thorpe
;
Outcome results
None listed