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Completed

NCT Number: NCT02599766

Effects of Animal-assisted Therapy on Brain-injured Patients

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.

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Key information

Conditions

Impaired Social Functioning Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHAB Basel

Basel, 4012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

animal assisted therapy

Other

physiotherapy, speech therapy and occupational therapy in the presence of an animal

Standard therapy

Other

standard physiotherapy, standard speech therapy and standard occupational therapy

Primary outcomes

  1. Social Functioning: Total Social Behavior

    Time frame: 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 outcomes

  1. Social Functioning: Verbal Communication

    Time frame: 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.

  2. Social Functioning: Nonverbal Communication

    Time frame: 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.

  3. Social Functioning: Physical Contact

    Time frame: 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.

  4. Social Functioning: Attention

    Time frame: 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.

  5. Positive Emotional Display

    Time frame: 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.

  6. Negative Emotional Display

    Time frame: 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.

  7. Neutral Emotional Display

    Time frame: 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.

  8. Mood 1: Motivation

    Time frame: 6 weeks

    Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)

  9. Mood 2: Bipolar Mood Dimension (Good-bad)

    Time frame: 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).

  10. Mood 3: Satisfaction Self-assessment

    Time frame: 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).

  11. Mood 4: Satisfaction Therapist Rating

    Time frame: 6 weeks

    Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).

  12. Heart Rate

    Time frame: 6 weeks

    Assessed via EKG (Polar) during the sessions and measured in beat/min.

  13. Motor Activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Institute for Interdisciplinary Research on the Human-Pet Relationship

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2015
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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