Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT06107595
Eligibility Criteria:
Inclusion Criteria:
* Spinal or thoracic elective surgery for the indications mentioned above
* Able to give informed consent
* Interested in trying COLP as complementary pain management therapy
* Able to fill a e-diary at home
Exclusion Criteria:
* Cognitive impairment (MOCA score \<26)
* Inability to engage in the intervention of the study e.g. inability to communicate in French without a translator, severe hearing impairment without any hearing aid available at the time of intervention, anosmia or intolerance to eugenol.
* Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention
* Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)
* Intolerance to placebo ingredients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06107595
Study Brief:
Protocol Section:
NCT06107595