Effects of Animal-assisted Therapy on Brain-injured Patients

Impaired Social Functioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599766
• Other study ID #: Ref.Nr.EK:296/13
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2019
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impaired Social Functioning

Intervention

Other:
• animal assisted therapy
physiotherapy, speech therapy and occupational therapy in the presence of an animal
• standard therapy
standard physiotherapy, standard speech therapy and standard occupational therapy

Locations

Country	Name	City	State
Switzerland	REHAB Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Institute for Interdisciplinary Research on the Human-Pet Relationship

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mood 1: Motivation	Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart Rate	Assessed via EKG (Polar) during the sessions and measured in beat/min.	6 weeks
Secondary	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