Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-10 @ 5:03 PM
Study NCT ID:
NCT02599766
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Animal-assisted Therapy on Brain-injured Patients
Sponsor:
Swiss Tropical & Public Health Institute
Organization:
Study Overview
Official Title:
Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 25 patients over 24 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.
Detailed Description:
This study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.
Over a period of six weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 24 therapy sessions (12 experimental, 12 control) for each patient.
Each therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires.
The study takes place at REHAB Basel. Animal-assisted therapies will be held at the "Therapie-Tiergarten" at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship.
Patients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition.
Participation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.
Over a period of six weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 24 therapy sessions (12 experimental, 12 control) for each patient.
Each therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires.
The study takes place at REHAB Basel. Animal-assisted therapies will be held at the "Therapie-Tiergarten" at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship.
Patients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition.
Participation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: