Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial

NCT ID: NCT03017027

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Psychosocial Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapy dog visitation (TDV)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

non-TDV control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Sandra M Branson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra M Branson, PhD, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-SN-14-0202

Identifier Type: -

Identifier Source: org_study_id