Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617247
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Burnout syndrome is an occupational disease that has affected health care providers for example caregivers of older adults This syndrome negatively affects physical and psychological health which may reflect on the mental health of the caregiver and the care provided to the older adults Interventions have been developed to minimize the impacts of burnout Thus this study has two main objectives 1 to identify the effect of cannabidiol on indicators of burnout and empathy of caregivers of older people with functional dependence for activities of daily living 2 identify possible associations between burnout indicators empathy levels and their domains and quality of care This is a two-phase study ie Phase 1 cross-sectional Phase 2 clinical trial In Phase 1 caregivers will answer questionnaires developed by researchers for sociodemographic characterization care and satisfaction of care In addition they will complete instruments to assess the functional dependence of the older people - EIAVD depressive symptoms - PHQ-9 social support - EAS Burnout syndrome - MBI and Empathy - EMRI and MET In Phase 2 caregivers will be randomized to cannabidiol or placebo intervention Caregivers with number 0 will be allocated to the intervention using cannabidiol 300mg - divided into two times a day and those drawn with number 1 will be allocated to the placebo group Both interventions will be performed for four weeks Caregivers will fill in the MBI EMRI MET NPI and QAO instruments before and after the intervention UKU-SERS will also be applied to evaluate side effects IECC to assess the impact of intervention on care and CGI to assess severity and response to treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None