Effects of Animal-assisted Therapy on Brain-injured Patients

Not Applicable

Completed

Conditions: Impaired Social Functioning

Interventions: Other: standard therapy
Other: animal assisted therapy

Registration Number: NCT02599766

Lead Sponsor: Swiss Tropical & Public Health Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
standard therapy	standard therapy	"Standard therapy" without the presence of an animal.
animal assisted therapy	animal assisted therapy	"Standard therapy" that is done in the presence and with integrating an animal.

Primary Outcome Measures

Name	Time	Method
Social Functioning: Total Social Behavior	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Social Functioning: Verbal Communication	6 weeks	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.
Social Functioning: Nonverbal Communication	6 weeks	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.
Social Functioning: Physical Contact	6 weeks	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.
Social Functioning: Attention	6 weeks	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.
Negative Emotional Display	6 weeks	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.
Neutral Emotional Display	6 weeks	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.
Mood 4: Satisfaction Therapist Rating	6 weeks	Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).
Positive Emotional Display	6 weeks	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.
Mood 1: Motivation	6 weeks	Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)
Mood 2: Bipolar Mood Dimension (Good-bad)	6 weeks	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).
Heart Rate	6 weeks	Assessed via EKG (Polar) during the sessions and measured in beat/min.
Mood 3: Satisfaction Self-assessment	6 weeks	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).
Motor Activity	6 weeks	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.