Trigeminal Neuralgia
Conditions
Brief summary
The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified: 1. To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs). 2. To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.
Detailed description
This study will engage up to 20 participants with TN through patient associations or HCPs. The study will be conducted in English Speaking countries. The study comprises the following parts : * Participants Recruitment * Completion of the Diary * Qualitative interviews with participants * Analysis of qualitative research to assess content validity * Secondary analysis as a workshop with a panel of experts to finalize the diary The diary will be provided to each participant and to HCPs. Participants will be requested to follow the instructions, use the diary and provide their feedback on the diary.
Interventions
OTHERPain Diary use
Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia
Sponsors
Noema Pharma AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Inclusion criteria
* Male or Female aged of 40 years or more. * Must be able to read, write, and speak English to complete the consent process and participate in an interview. * Able and willing to provide consent for participation in the study, and to allow the study team to access their data entries including audio or video recordings. - - Participant with a current or previous diagnosis of TN * Willing to participate in up to 30 minutes remote interviews or in-person interview (this interview will be recorded by the HCP) * Committ to fill in the diary according to the HCP instruction
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of pain associated with Trigeminal Neuralgia | 2 weeks | Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia |
| Concept elicitation of the diary content | 1 day | During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience |
Countries
United Kingdom, United States
Outcome results
None listed