Rheumatology clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT02832050 Withdrawn - Pain Clinical Trials

PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study)

PLAYTIME

Start date: March 8, 2016
Phase: N/A
Study type: Interventional

Study synopsis Objectives - To determine whether delivering a semi-structured play therapy intervention can improve procedure-related anxiety / ability to cope with a procedure / procedure-related pain for children and young people. - To determine whether delivering a semi-structured play therapy intervention can improve patient experience of blood monitoring. Patients - Patients aged 5 - 17 years who are under the care of the rheumatology team. - Patients expected to require at least two blood tests during a 12 week period. Design - Recruitment over 24 weeks with each child in the study for a 12 week period. - 20 patients will receive play therapy intervention as outlined in the play therapy intervention for blood tests. - 20 patients will be the comparator group. They will be offered standard care for blood tests. - All children will be offered local anaesthetic cream for each blood test. Blood tests will be performed by venepuncture unless specifically requested otherwise by patient. - All children will complete outcome measures at baseline, beginning and end of each procedure session and at completion of the study at 16 weeks. Outcome Measures - Procedure-related anxiety visual analogue scale (VAS) score - completed by child - Observer procedure-related anxiety VAS score - completed by parent - Procedure-related coping VAS score - completed by child - Procedure-related pain VAS score - completed by child - Patient experience VAS score - completed by child and parent separately