Trial Outcomes & Findings for Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents (NCT NCT04310345)
NCT ID: NCT04310345
Last Updated: 2024-08-19
Results Overview
The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
Up to 2 months
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Animal-Assisted Interaction -- Child Participants
Children will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
Animal-Assisted Interactions: Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
|
Animal-Assisted Interaction -- Adult Participants
Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
Animal-Assisted Interactions: Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
43
|
|
Overall Study
COMPLETED
|
28
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Baseline characteristics by cohort
| Measure |
Animal-Assisted Interaction - Child Participants
n=31 Participants
Children will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
Animal-Assisted Interactions: Child will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
|
Animal-Assisted Interaction - Caregiver Participants
n=43 Participants
Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
Animal-Assisted Interactions: Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
43 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 monthsPopulation: Children ages 6-17 with relapsed or refractory cancer and their caregivers who participated in therapy dog visits for up to 8 weeks at clinic visits or in the hospital.
The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life.
Outcome measures
| Measure |
Animal-Assisted Interaction - Child Participants (Baseline)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Baseline visit data on quality of life obtained through PedsQL survey without seeing therapy dog.
|
Animal-Assisted Interaction - Child Participants (Week 4)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 4 data PedsQL survey conducted after seeing therapy dog.
|
Animal-Assisted Interaction - Child Participants (Week 8)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 8 data PedsQL survey conducted after seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Baseline)
n=21 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Baseline data obtained without seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Week 4)
n=21 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 4 data obtained after seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Week 8)
n=21 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 8 data obtained after seeing therapy dog.
|
|---|---|---|---|---|---|---|
|
Pediatric Quality of Life
PedsQL (Emotional)
|
65.6 score on a scale
Standard Deviation 20.6
|
65.7 score on a scale
Standard Deviation 19.0
|
71.3 score on a scale
Standard Deviation 20.1
|
51.9 score on a scale
Standard Deviation 16.1
|
53.8 score on a scale
Standard Deviation 18.4
|
58.8 score on a scale
Standard Deviation 15.1
|
|
Pediatric Quality of Life
PedsQL (Physical)
|
47.6 score on a scale
Standard Deviation 18.1
|
50.3 score on a scale
Standard Deviation 23.5
|
61.6 score on a scale
Standard Deviation 27.7
|
41.5 score on a scale
Standard Deviation 24.1
|
37.8 score on a scale
Standard Deviation 18.8
|
47.8 score on a scale
Standard Deviation 24.7
|
|
Pediatric Quality of Life
PedsQL (Social)
|
72.5 score on a scale
Standard Deviation 21.6
|
66.7 score on a scale
Standard Deviation 23.1
|
66.7 score on a scale
Standard Deviation 25.1
|
63.8 score on a scale
Standard Deviation 20.5
|
61.4 score on a scale
Standard Deviation 17.8
|
62.9 score on a scale
Standard Deviation 20.7
|
|
Pediatric Quality of Life
PedsQL (School)
|
48.0 score on a scale
Standard Deviation 22.4
|
50.0 score on a scale
Standard Deviation 21.3
|
56.7 score on a scale
Standard Deviation 25.4
|
46.4 score on a scale
Standard Deviation 19.2
|
50.5 score on a scale
Standard Deviation 23.4
|
58.8 score on a scale
Standard Deviation 21.8
|
|
Pediatric Quality of Life
PedsQL (Psycho-Social)
|
64.1 score on a scale
Standard Deviation 17.5
|
64.9 score on a scale
Standard Deviation 18.6
|
69.6 score on a scale
Standard Deviation 20.0
|
52.3 score on a scale
Standard Deviation 16.0
|
54.4 score on a scale
Standard Deviation 17.0
|
60.5 score on a scale
Standard Deviation 13.9
|
|
Pediatric Quality of Life
PedsQL (Overall)
|
55.7 score on a scale
Standard Deviation 14.7
|
56.9 score on a scale
Standard Deviation 18.2
|
64.7 score on a scale
Standard Deviation 19.5
|
47.1 score on a scale
Standard Deviation 15.9
|
47.5 score on a scale
Standard Deviation 16.0
|
55.0 score on a scale
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: Up to 2 monthsThe state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8.
Outcome measures
| Measure |
Animal-Assisted Interaction - Child Participants (Baseline)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Baseline visit data on quality of life obtained through PedsQL survey without seeing therapy dog.
|
Animal-Assisted Interaction - Child Participants (Week 4)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 4 data PedsQL survey conducted after seeing therapy dog.
|
Animal-Assisted Interaction - Child Participants (Week 8)
n=29 Participants
Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 8 data PedsQL survey conducted after seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Baseline)
n=29 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Baseline data obtained without seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Week 4)
n=29 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 4 data obtained after seeing therapy dog.
|
Animal-Assisted Interaction - Caregiver Participants (Week 8)
n=29 Participants
Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 8 data obtained after seeing therapy dog.
|
|---|---|---|---|---|---|---|
|
Anxiety
|
31.4 units on a scale
Standard Deviation 5.2
|
29.2 units on a scale
Standard Deviation 4.5
|
29.5 units on a scale
Standard Deviation 5.8
|
40.2 units on a scale
Standard Deviation 11.9
|
35.6 units on a scale
Standard Deviation 10.9
|
35.9 units on a scale
Standard Deviation 11.2
|
Adverse Events
Animal-Assisted Interaction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place