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Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness

Primary Purpose

Disorder of Consciousness

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
animal assisted therapy
standard therapy
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatients of REHAB Basel
  • Disorder of consciousness: minimal conscious state defined via:
  • CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1
  • BAVESTA Score of 2.8

Exclusion Criteria:

  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • medical contraindications for contact with animals as allergy, phobia etc.
  • If the patient's medication changes radically during the time of data collection

Sites / Locations

  • REHAB Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

animal assisted therapy

standard therapy

Arm Description

"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.

standard physiotherapy, standard speech therapy and standard occupational therapy

Outcomes

Primary Outcome Measures

Degree of consciousness
assessed via behavioral coding in Noldus Observer

Secondary Outcome Measures

Heart rate
assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)
Behavioral reaction
measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)

Full Information

First Posted
December 7, 2015
Last Updated
May 14, 2018
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel
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1. Study Identification

Unique Protocol Identification Number
NCT02629302
Brief Title
Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness
Official Title
Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. The focus lies on 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 10 patients during 16 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 in a minimal conscious state are recruited.
Detailed Description
This pilot 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 four 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 16 therapy sessions (8 experimental, 8 control) for each patient. Each therapy session lasts about 20 minutes. The study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist. Patients are allocated randomly to start with either the experimental or the control condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
animal assisted therapy
Arm Type
Experimental
Arm Description
"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.
Arm Title
standard therapy
Arm Type
Active Comparator
Arm Description
standard physiotherapy, standard speech therapy and standard occupational therapy
Intervention Type
Other
Intervention Name(s)
animal assisted therapy
Intervention Description
physiotherapy, speech therapy and occupational therapy in the presence of an animal
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
standard physiotherapy, speech therapy and occupational therapy
Primary Outcome Measure Information:
Title
Degree of consciousness
Description
assessed via behavioral coding in Noldus Observer
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Heart rate
Description
assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)
Time Frame
4 weeks
Title
Behavioral reaction
Description
measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients of REHAB Basel Disorder of consciousness: minimal conscious state defined via: CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1 BAVESTA Score of 2.8 Exclusion Criteria: Enrolment of the investigator, his/her family members, employees and other dependent persons medical contraindications for contact with animals as allergy, phobia etc. If the patient's medication changes radically during the time of data collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Hediger
Organizational Affiliation
Rehab Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
REHAB Basel
City
Basel
ZIP/Postal Code
4012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31574106
Citation
Hediger K, Petignat M, Marti R, Hund-Georgiadis M. Animal-assisted therapy for patients in a minimally conscious state: A randomized two treatment multi-period crossover trial. PLoS One. 2019 Oct 1;14(10):e0222846. doi: 10.1371/journal.pone.0222846. eCollection 2019.
Results Reference
derived

Learn more about this trial

Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness

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