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Helping Improve Pediatric Patient Outcomes

NCT03471221 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-03-31

No results posted yet for this study

Summary

This study involves two distinct activities:

The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy dog visits for children with cancer. This activity has the following specific objectives:

1. To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients.
2. To determine whether therapy dog visits increase microbial levels on children's hands.

The Investigators hypothesize that therapy dog visits will reduce patient distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care. The Investigators further hypothesize that therapy dog visits (including standard hand sanitization) will not increase microbial levels on children's hands.

Once the main study aims for the first study activity have been completed, the research study team will begin recruitment for the second activity. The second activity is an observational study to describe microbial levels before a dog visit, after a dog visit but before hand cleaning, and after hand cleaning. This phase will provide additional information for Aim 2 that cannot be obtained during the RCT given the nature of the RCT design. The Investigators will proceed with the observational study only if all main study activities can be completed within the study timeline.

Conditions

  • Pediatric Cancer, Animal-Assisted Activities

Interventions

BEHAVIORAL

Therapy Dog Visit

Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria. Key features of AAA are as follows: 1. Specific treatment goals are not planned for each visit. 2. Volunteers and treatment providers are not required to take detailed notes. 3. Visit content and activities are spontaneous. 4. Visit length can be as long or as short as needed.

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2020-02-29
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471221 on ClinicalTrials.gov