Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 8:04 PM
Study NCT ID:
NCT07221006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Facility Dog Intervention on Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-10-23', 'studyFirstSubmitQcDate': '2025-10-23', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spielberger State Trait Anxiety Inventory Short Form', 'timeFrame': 'Baseline and approximately 15 minutes after starting the intervention.', 'description': 'A 6-item measure that assesses anxiety via self-report. Individuals rate their agreement with six statements on a 4-point scale, ranging from 1 (not at all) to 4 (very much), with higher scores indicating more anxiety.'}, {'measure': "Children's Fear Scale", 'timeFrame': 'Baseline and approximately 15 minutes after starting the intervention.', 'description': 'A 1-item measure that assesses fear via self-report faces scale. Individuals rate their fear on a scale, ranging from no fear to extreme fear, by selecting one of five face pictures that matches how they feel.'}, {'measure': 'Coping Questionnaire - Child', 'timeFrame': 'Approximately 15 minutes after starting the intervention.', 'description': "Measures youth's perceived ability to cope on a three-item, individualized measure. Children rate their ability to make themselves less upset during an anxiety-provoking situation on a 7-point scale, ranging from 1 (not at all able to help myself or him/herself) to 7, with lower scores indicating poor coping."}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'Baseline, before the intervention, 5 minutes after intervention start, post-intervention (approximately 15 minutes after intervention start).', 'description': "Participants' heart rate will be measured at four time points using a bedside heart rate monitor."}, {'measure': 'Parent Survey', 'timeFrame': 'Before the intervention.', 'description': 'Legal guardians will be if the participant has any developmental and/or psychological diagnoses, as well as if the patient has a dog at home.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotional Support Dog', 'Pet Therapy Dog', 'Child Life Specialist', 'anxiety', 'fear'], 'conditions': ['Inpatients', 'Pediatric']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if medical dog intervention facilitated by a Certified Child Life Specialist (CCLS) impacts pediatric patient coping, fear, and anxiety during inpatient admissions. The main questions it aims to answer are:\n\nWhat impact does facility dog support via a CCLS have on patient fear, coping, and anxiety? What effect does facility dog support via a CCLS have on patient heart rate? Researchers will compare medical dog intervention facilitated by a CCLS, CCLS intervention, and a coloring activity to see if medical dog interventions positively impact coping, fear, and anxiety.\n\nParticipants will:\n\nReceive a visit from a medical dog and their CCLS handler, a CCLS, or a Child Life Activity coordinator.\n\nEngage in a mindfulness or coloring activity. Answer surveys regarding anxiety, coping, and fear. Have their heart rate measured before, during, and after their assigned intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children admitted to an inpatient unit at Children's Hospital Colorado Anschutz Medical Campus\n* Who are eight to 17 years old.\n\nExclusion Criteria:\n\n* Isolation precautions\n* Primary reason for admission is due to suicidality, self-injurious behavior, or injurious behavior\n* Patients with history of or currently presenting with aggression or unsafe behavior\n* Severe comorbidities secondary to traumatic brain injury, neurological disorder or neurodevelopmental issues that may confound study outcomes and administration of the study protocol (e.g., intellectual disability)\n* Not medically stable\n* Have a fear of dogs\n* Have an allergy to dogs\n* Have had a visit from a medical dog and medical dog handler during their current admission\n* Patient has an urgent or time-sensitive need requiring medical dog support - Patient is non-verbal."}, 'identificationModule': {'nctId': 'NCT07221006', 'briefTitle': 'Impact of Facility Dog Intervention on Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Colorado"}, 'officialTitle': 'Investigating the Impact of Facility Dog Intervention on Pediatric Patient Fear, Coping, and Anxiety During Inpatient Admission', 'orgStudyIdInfo': {'id': '25-1381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child life specialist intervention + facility dog led mindfulness', 'description': "Participants will receive a 20-minute mindfulness coping intervention from a CCLS handler and their facility dog. The CCLS will introduce themselves and their facility dog and explain the activity, then implement a guided mindfulness activity while the child holds their hand on the facility dog's stomach/chest.", 'interventionNames': ['Behavioral: Mindfulness Activity led by CCLS and Facility Dog']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Child life specialist led mindfulness', 'description': 'Participants will receive a 20-minute mindfulness coping intervention from a CCLS. The CCLS will introduce themselves and their role and explain the activity and then implement a guided mindfulness activity while the child holds a stress ball.', 'interventionNames': ['Behavioral: Mindfulness Activity led by CCLS']}, {'type': 'OTHER', 'label': 'Child life activity coordinator led coloring activity', 'description': 'Participants will complete a 20-minute coloring activity facilitated by a Child Life Activity Coordinator (CLAC). Children aged 8-12 years old will be provided a medical dog coloring sheet with crayons; children aged 13-17 years old will be provided an adult coloring sheet that uses a dog image and colored pencils.', 'interventionNames': ['Behavioral: Coloring page activity led by CLAC']}], 'interventions': [{'name': 'Coloring page activity led by CLAC', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided coloring pages and colored pencils or crayons led by a Child Life Activity Coordinator, and will engage in the activity for 15 minutes.', 'armGroupLabels': ['Child life activity coordinator led coloring activity']}, {'name': 'Mindfulness Activity led by CCLS', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in a 10 minute mindfulness activity led by a Certified Child Life Specialist who will follow a mindfulness script. Participants will hold a stress ball during the activity.', 'armGroupLabels': ['Child life specialist led mindfulness']}, {'name': 'Mindfulness Activity led by CCLS and Facility Dog', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in a 10 minute mindfulness activity led by a Certified Child Life Specialist who will follow a mindfulness script. Participants will be able to be next to and touch the medical dog during the activity.', 'armGroupLabels': ['Child life specialist intervention + facility dog led mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Claire Simonsen, BA', 'role': 'CONTACT', 'email': 'claire.simonsen@childrenscolorado.org', 'phone': '720-777-5313'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Claire Simonsen, BA', 'role': 'CONTACT', 'email': 'claire.simonsen@childrenscolorado.org', 'phone': '720-777-5313'}], 'overallOfficials': [{'name': 'Sarah Scott', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Colorado", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Scott', 'investigatorAffiliation': "Children's Hospital Colorado"}}}}