Overview
Animal-Assisted Visitation Program Chlorhexidine Trial
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-05-01
2023-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Johns Hopkins Bloomberg School of Public HealthCollaborators:
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of PennsylvaniaTreatments:
Chlorhexidine
Chlorhexidine gluconate
Criteria
Inclusion Criteria:- Children between the ages of 3 and 17 years
- Cleared by physician to participate in a hospital-based animal-assisted visitation
program session with any enrolled dog
Exclusion Criteria:
- Children who report sensitivity to chlorhexidine products
- Children who report allergy to dogs or sensitivity to dog allergen