Impaired Social Functioning
Conditions
Keywords
animal assisted intervention, brain injury, rehabilitation
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.
Interventions
OTHERanimal assisted therapy
physiotherapy, speech therapy and occupational therapy in the presence of an animal
OTHERstandard therapy
standard physiotherapy, standard speech therapy and standard occupational therapy
Sponsors
Institute for Interdisciplinary Research on the Human-Pet Relationship
Swiss Tropical & Public Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| Heart Rate | 6 weeks | Assessed via EKG (Polar) during the sessions and measured in beat/min. |
| 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. |
| Mood 1: Motivation | 6 weeks | Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated) |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AAT and Control Intervention Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal
Control intervention: standard physiotherapy, speech therapy and occupational therapy | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | AAT and Control Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 50.84 years STANDARD_DEVIATION 14.4 |
| FIM (Functional Independence Measure) | 68.67 units on a scale STANDARD_DEVIATION 26.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment Switzerland | 19 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Social Functioning: Total Social Behavior | 29.22 percentage of shown behavior | Standard Deviation 15.66 |
| Standard Therapy | Social Functioning: Total Social Behavior | 8.68 percentage of shown behavior | Standard Deviation 8.85 |
Secondary
Heart Rate
Assessed via EKG (Polar) during the sessions and measured in beat/min.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Heart Rate | 85.23 beats per minute | Standard Deviation 13.03 |
| Standard Therapy | Heart Rate | 83.41 beats per minute | Standard Deviation 14.86 |
Secondary
Mood 1: Motivation
Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Mood 1: Motivation | 138.80 units on a scale | Standard Deviation 27.13 |
| Standard Therapy | Mood 1: Motivation | 132.22 units on a scale | Standard Deviation 28.21 |
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Mood 2: Bipolar Mood Dimension (Good-bad) | 16.93 units on a scale | Standard Deviation 4.2 |
| Standard Therapy | Mood 2: Bipolar Mood Dimension (Good-bad) | 16.12 units on a scale | Standard Deviation 4.29 |
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Mood 3: Satisfaction Self-assessment | 129.81 units on a scale | Standard Deviation 23.8 |
| Standard Therapy | Mood 3: Satisfaction Self-assessment | 124.54 units on a scale | Standard Deviation 37.81 |
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Mood 4: Satisfaction Therapist Rating | 137.31 units on a scale | Standard Deviation 23.8 |
| Standard Therapy | Mood 4: Satisfaction Therapist Rating | 128.14 units on a scale | Standard Deviation 27.75 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Motor Activity | 90.93 counts per minute | Standard Deviation 55.45 |
| Standard Therapy | Motor Activity | 75.88 counts per minute | Standard Deviation 60.67 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Negative Emotional Display | 0.31 percentage of negative emotion | Standard Deviation 1.34 |
| Standard Therapy | Negative Emotional Display | 0.59 percentage of negative emotion | Standard Deviation 2.05 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Neutral Emotional Display | 92.73 percentage of neutral emotion | Standard Deviation 7.64 |
| Standard Therapy | Neutral Emotional Display | 94.20 percentage of neutral emotion | Standard Deviation 6.6 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Positive Emotional Display | 6.95 percentage of positive emotion | Standard Deviation 7.47 |
| Standard Therapy | Positive Emotional Display | 3.75 percentage of positive emotion | Standard Deviation 4.57 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Social Functioning: Attention | 89.01 percentage of attention | Standard Error 2.01 |
| Standard Therapy | Social Functioning: Attention | 90.65 percentage of attention | Standard Error 2 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Social Functioning: Nonverbal Communication | 31.94 percentage of nonverbal communication | Standard Deviation 17.54 |
| Standard Therapy | Social Functioning: Nonverbal Communication | 5.26 percentage of nonverbal communication | Standard Deviation 7.09 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Social Functioning: Physical Contact | 18.32 percentage of physical contact | Standard Deviation 18.5 |
| Standard Therapy | Social Functioning: Physical Contact | 1.53 percentage of physical contact | Standard Deviation 9.7 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal Assisted Therapy | Social Functioning: Verbal Communication | 25.4 percentage of verbal communication | Standard Deviation 19.44 |
| Standard Therapy | Social Functioning: Verbal Communication | 19.04 percentage of verbal communication | Standard Deviation 20.24 |