Effects of Animal-assisted Therapy on Brain-injured Patients

Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel

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.

Study Overview

• Status: Completed
• Conditions: Impaired Social Functioning
• Intervention / Treatment: Other: animal assisted therapy; Other: standard therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4012
    • REHAB Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient at REHAB Basel
• brain-injury
• willing to participate in animal-assisted therapies
• physical and psychological resilience and ability to go/be transported outside to the "Therapie-Tiergarten"
• ability to get in contact with the animal autonomously

Exclusion Criteria:

• medical contraindications:allergies, phobias, etc.
• no willingness to participate in animal-assisted therapies
• patient might present a danger to the animals (aggressive behaviour)
• patient's medication changes radically during the time of data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: animal assisted therapy; "Standard therapy" that is done in the presence and with integrating an animal.	Other: animal assisted therapy; physiotherapy, speech therapy and occupational therapy in the presence of an animal
Active Comparator: standard therapy; "Standard therapy" without the presence of an animal.	Other: standard therapy; standard physiotherapy, standard speech therapy and standard occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Functioning: Total Social Behavior	Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Functioning: Verbal Communication	Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure.	6 weeks
Social Functioning: Nonverbal Communication	Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure.	6 weeks
Social Functioning: Physical Contact	Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure.	6 weeks
Social Functioning: Attention	Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure.	6 weeks
Positive Emotional Display	Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion.	6 weeks
Negative Emotional Display	Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion.	6 weeks
Neutral Emotional Display	Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion.	6 weeks
Mood 1: Motivation	Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)	6 weeks
Mood 2: Bipolar Mood Dimension (Good-bad)	Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood).	6 weeks
Mood 3: Satisfaction Self-assessment	Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).	6 weeks
Mood 4: Satisfaction Therapist Rating	Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).	6 weeks
Heart Rate	Assessed via EKG (Polar) during the sessions and measured in beat/min.	6 weeks
Motor Activity	Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute.	6 weeks

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Institute for Interdisciplinary Research on the Human-Pet Relationship
• Investigators: Principal Investigator: Margret Hund-Georgiadis, PD Dr., REHAB Basel

Publications and helpful links

General Publications

• Gocheva V, Hund-Georgiadis M, Hediger K. Effects of animal-assisted therapy on concentration and attention span in patients with acquired brain injury: A randomized controlled trial. Neuropsychology. 2018 Jan;32(1):54-64. doi: 10.1037/neu0000398. Epub 2017 Oct 16.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: animal assisted intervention, brain injury, rehabilitation
• Other Study ID Numbers: Ref.Nr.EK:296/13