Overview

Animal-Assisted Visitation Program Chlorhexidine Trial

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
Treatments:
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