Animal-Assisted Visitation Program Chlorhexidine Trial

Last updated: January 21, 2025
Sponsor: Johns Hopkins Bloomberg School of Public Health
Overall Status: Active - Recruiting

Phase

4

Condition

Pressure Ulcers

Treatment

Chlorhexidine

Clinical Study ID

NCT04171817
R01HD097692
IRB00205311
  • Ages 3-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children between the ages of 3 and 17 years

  • Cleared by physician to participate in a hospital-based animal-assisted visitationprogram session with any enrolled dog

Exclusion

Exclusion Criteria:

  • Children who report sensitivity to chlorhexidine products

  • Children who report allergy to dogs or sensitivity to dog allergen

Study Design

Total Participants: 412
Treatment Group(s): 1
Primary Treatment: Chlorhexidine
Phase: 4
Study Start date:
May 01, 2023
Estimated Completion Date:
December 01, 2026

Study Description

Hospital-based Animal-Assisted visitation programs provide an important complementary treatment in holistic patient care and reduce patient stress, pain and anxiety. However, the risk of transmission of pathogens, such as methicillin-resistant Staphylococcus aureus, is a challenge to the sustainability of hospital-based Animal-Assisted visitation 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. Therefore, child participants will be enrolled who interact with 40 dogs over twelve sessions (four observational, eight where the dog is randomized to intervention or control) at two enrollment centers. 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. If findings support the hypothesis that chlorhexidine interventions are effective to prevent pathogen transmission through a multicenter, parallel-arm randomized controlled trial and does not reduce Animal-Assisted visitation program benefits to the children or impact the welfare of the therapy dogs, then this will provide strong evidence on which to base recommendations for infection control guidelines for programs nationally.

Connect with a study center

  • Johns Hopkins

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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