- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017027
Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
January 9, 2017 updated by: Sandra M Branson, The University of Texas Health Science Center, Houston
The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by comparing responses between TDV and non-TDV control groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- understand English
- alert and oriented to person, place, and time
- able to complete study instruments
- able to provide saliva specimens, and
- consent from parent/legal guardian, and
- assent from child.
Exclusion Criteria:
- currently taking hormone replacement, or steroidal antiinflammatory medications
- in contact precautions at facility
- diagnosed with Addison's or Cushing's disease, and
- fears, phobias, or allergies to dogs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapy dog visitation (TDV)
The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient.
The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation.
For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit.
The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV.
The therapy dog will be leashed and controlled by the dog handler.
If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient.
The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV.
Tactile and visual contact with the dog will be promoted.
|
The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient.
The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation.
For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit.
The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV.
The therapy dog will be leashed and controlled by the dog handler.
If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient.
The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV.
Tactile and visual contact with the dog will be promoted.
|
Other: non-TDV control
Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities.
At the end of the session, a stuffed animal will be offered to the participant to keep.
|
Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities.
At the end of the session, a stuffed animal will be offered to the participant to keep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale
Time Frame: immediately before session, immediately after session
|
State anxiety will be measured using the State Anxiety Inventory for Children (STAI-C), a widely used instrument with upper elementary or junior high school aged children.
The instrument is composed of 20 statements that ask about how one feels at a particular moment in time with three responses from "very to not".
Scores range from 20 to 80 and higher scores indicate a higher state of anxiety.
Internal consistency has been demonstrated; researchers have reported acceptable reliability coefficients in hospitalized children ages 7-11 years old with Cronbach's α of .94.
|
immediately before session, immediately after session
|
Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
Time Frame: immediately before session, immediately after session
|
The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad.
The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely").
The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82
for the negative scale.
|
immediately before session, immediately after session
|
Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
Time Frame: immediately before session, immediately after session
|
The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad.
The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely").
The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82
for the negative scale.
|
immediately before session, immediately after session
|
Change in biological stress response as assessed by salivary cortisol levels
Time Frame: immediately before session, immediately after session
|
Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory).
Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity.
On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
|
immediately before session, immediately after session
|
Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels
Time Frame: immediately before session, immediately after session
|
Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory).
Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity.
On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
|
immediately before session, immediately after session
|
Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels
Time Frame: immediately before session, immediately after session
|
Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory).
Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity.
On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
|
immediately before session, immediately after session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attachment level to pets as assessed by the Pet Attitude Scale (PAS)
Time Frame: immediately before session
|
Attachment to pets will be measured using the Pet Attitude Scale (PAS)Questionnaire.The PAS is an 18 item paper and pencil instrument with 7 Likert response statements which measures the favorableness of attitudes towards pets.
Higher scores indicate more positive attitudes towards pets.
Evidence of PAS-M is demonstrated with a Cronbach's alpha of .93.
|
immediately before session
|
Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)
Time Frame: immediately after session
|
The Human-Animal Interaction Scale (HAIS) is a newly developed questionnaire designed to measure behavioral interactions between animal and human which predict beneficial effects to humans (Fournier, Letson, Laitalia, & Krog, 2015).
The HAIS is a 26 item Likert Scale with 5 Likert response statements ranging from "not at all" to "a great deal" and is completed by the participant after the TDV.
|
immediately after session
|
Human-Animal Interaction as assessed by the HAIS observer questionnaire
Time Frame: immediately after session
|
The HAIS observer questionnaire is a 24 item instrument completed by the research staff who quantifies behaviors with a percent or range in respect to the behavior observed.
|
immediately after session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sandra M Branson, PhD, MSN, RN, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
January 9, 2017
First Posted (Estimate)
January 11, 2017
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SN-14-0202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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