Helping Improve Pediatric Patient Outcomes
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 11/23/2018 |
| Start Date: | March 19, 2018 |
| End Date: | April 2019 |
| Contact: | Rene J Hawkes, BS |
| Email: | hawkes.r@ghc.org |
| Phone: | 206-287-2073 |
Psychological Benefits and Potential Pathogen Transmission in Hospitalized Pediatric Oncology Patients Receiving Therapy Dog Visits: a Randomized Controlled Trial
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.
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.
This study tests whether therapy dog visits reduce distress, lower treatment-related anxiety,
increase happiness, and improve satisfaction with hospital care, and whether these visits
transmit pathogens.
The first activity is a randomized controlled trial (RCT) in which patients will be
randomized to either the intervention (therapy dog visits) or control (usual care). All
patients will complete a baseline survey and hand sampling (i.e., removal of materials of
hands via use of liquid inside a glove) and answer questions from study staff (e.g., about
pets at home, which hand is dominant) before randomization. Parents will also complete a
baseline survey. Patients in the intervention group will receive therapy dog visits. At the
first therapy dog visit after enrollment, the research study team will collect visit-level
psychosocial measures and perform hand sampling. Similar procedures will be performed on
usual care patients. Patients in the intervention group will receive subsequent dog visits
~1x/week for up to 4 weeks if there sufficient dog team capacity. At hospital discharge, ~3
days post-discharge and 9 weeks post-discharge, the research study team will administer
surveys to patients and their parents in both groups.
Informed consent/assent will be performed for patients who agree to participate in the study
and preliminarily meet eligibility criteria. The parent/legal guardians of participants who
are enrolled in will be approached for their informed consent to complete surveys. After
informed consent/assent has been obtained, baseline surveys will be administered and hand
samples will be collected. The study staff will then assess the patient's ability to tolerate
and willingness to perform future psychological assessments and hand samplings. Patients
willing to proceed with the study will be randomized to either the intervention arm (visits
from a therapy dog) or the control arm (no visits from a therapy dog). Participants will be
randomized (1:1) to each group and stratified by age (≥13 vs <13 years). Participants will
maintain their randomization assignment during any subsequent hospitalizations that occur
during their participation in the study.
The second activity is an observational study of patients receiving therapy dog visits that
will provide additional information on microbial levels. The observational study which
involves a one-time therapy dog visit. Children will be instructed to touch the dog with both
hands. Both hands will be sampled before the visit. A randomly selected hand will be sampled
immediately after the visit (before hand sanitization). The other hand will be sampled after
sanitization.
increase happiness, and improve satisfaction with hospital care, and whether these visits
transmit pathogens.
The first activity is a randomized controlled trial (RCT) in which patients will be
randomized to either the intervention (therapy dog visits) or control (usual care). All
patients will complete a baseline survey and hand sampling (i.e., removal of materials of
hands via use of liquid inside a glove) and answer questions from study staff (e.g., about
pets at home, which hand is dominant) before randomization. Parents will also complete a
baseline survey. Patients in the intervention group will receive therapy dog visits. At the
first therapy dog visit after enrollment, the research study team will collect visit-level
psychosocial measures and perform hand sampling. Similar procedures will be performed on
usual care patients. Patients in the intervention group will receive subsequent dog visits
~1x/week for up to 4 weeks if there sufficient dog team capacity. At hospital discharge, ~3
days post-discharge and 9 weeks post-discharge, the research study team will administer
surveys to patients and their parents in both groups.
Informed consent/assent will be performed for patients who agree to participate in the study
and preliminarily meet eligibility criteria. The parent/legal guardians of participants who
are enrolled in will be approached for their informed consent to complete surveys. After
informed consent/assent has been obtained, baseline surveys will be administered and hand
samples will be collected. The study staff will then assess the patient's ability to tolerate
and willingness to perform future psychological assessments and hand samplings. Patients
willing to proceed with the study will be randomized to either the intervention arm (visits
from a therapy dog) or the control arm (no visits from a therapy dog). Participants will be
randomized (1:1) to each group and stratified by age (≥13 vs <13 years). Participants will
maintain their randomization assignment during any subsequent hospitalizations that occur
during their participation in the study.
The second activity is an observational study of patients receiving therapy dog visits that
will provide additional information on microbial levels. The observational study which
involves a one-time therapy dog visit. Children will be instructed to touch the dog with both
hands. Both hands will be sampled before the visit. A randomly selected hand will be sampled
immediately after the visit (before hand sanitization). The other hand will be sampled after
sanitization.
Inclusion Criteria:
English-speaking patients aged 5-17 years who have been admitted to the Seattle Children's
Hospital Cancer Care Unit and who are on the oncology service irrespective of specific
oncologic diagnosis, sex, race, and ethnicity.
Exclusion Criteria:
Are allergic to dogs or have a sensitivity to dogs; Are afraid of dogs; Are on the bone
marrow transplant service; Have isolation precautions in place per Infection Prevention
policies (e.g. viral respiratory precautions, contact precautions, etc.); Skin on hands not
intact (e.g. moderate to severe eczema involving the hands or other generalized skin
breakdown); Have no English-speaking parent/legal guardian; Have no parent/legal guardian
able to provide written consent; For observational study, unwilling or unable to pet the
dog with both hands.
We found this trial at
1
site
Seattle, Washington 28124
Phone: 206-287-2071
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