Animal-Assisted Visitation Program Chlorhexidine Trial

NCT ID: NCT04171817

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-07-15

Brief 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.

Detailed 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.

Conditions

Methicillin-resistant Staphylococcus Aureus; Clostridium Difficile; Pseudomonas Aeruginosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Dog-handler teams will follow established hospital and therapy dog program guidelines for infection control with no changes for eight sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CHX Intervention A

Dog-handler teams will follow a modified protocol for infection control, with Treatment A first for four sessions, and cross-over to Treatment B for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.

Treatment A consists of a pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine) within 24 hours prior to the session, and wiping with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival at the session and every 20 minutes during the session, or between participants if the flow of participants is structured in a way that allows this (such as visits from one room to the next to visit individual patients).

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs

CHX Intervention B

Dog-handler teams will follow a modified protocol for infection control, with Treatment B first for four sessions, and cross-over to Treatment A for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.

Treatment B will consist of the same pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine), with a single wipe with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival. This treatment will depend on the residual activity of chlorhexidine throughout the visit.

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs

Interventions

Chlorhexidine

The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs

Intervention Type: DRUG

Other Intervention Names

CHX

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghan F Davis, DVM, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins

Baltimore, Maryland, United States

Washington University in St. Louis

St Louis, Missouri, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB00205311

Identifier Type: OTHER

Identifier Source: secondary_id

R01HD097692

Identifier Type: NIH

Identifier Source: org_study_id

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