Measuring Effects of Contact to Dogs

Study Overview
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Brief Summary
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The study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog control condition while obtaining measures of both physiological, behavioral, and psychological effects.

Detailed Description
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Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact: 1) visual (V), 2) tactile and visual (TV), 3) tactile, visual, interaction (TVI), and 4)control (C). The participants will be subjected to all four test situations on the same day, and will be randomly allocated to test order. On the test day, we collect background information and baseline measures for the participants (baseline period, duration: 50 minutes), whereafter they rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the four test situations (10 minutes each) that are followed by rest intervals (30 minutes each). The participants' interaction with the dog during the 10-minute test situations are standardised according to the specific contact treatment. Most physiological and all behavioural measures are recorded continuously throughout each test in order for us to link the dosage of dog (the different levels of contact) with the psychological responses and some physiological measures obtained before an after each test situation. Below is shown the exact time schedule of the test day, that we refer to when describing the outcome measures. The baseline period (30 minutes) is not included in the total test period (total duration= 190 minutes), that consist of a pre-intervention and intervention period. Baseline period (50 minutes - not part of total test period) Pre-intervention period (start, t=0 minutes; end t= 30 minutes) Test situation 1 (start, t=30 minutes; end, t=40 minutes) Rest period 1 (start, t=40 minutes, end, t= 70 minutes) Test situation 2 (start, t=70 minutes; end, t=80 minutes) Rest period 2 (start, t=80 minutes, end, t= 110 minutes) Test situation 3 (start, t=110 minutes; end, t=120 minutes) Rest period 3 (start, t=120 minutes, end, t= 150 minutes) Test situation 4 (start, t=150 minutes; end, t=160 minutes) Rest period 4 (start, t=160 minutes, end, t= 190 minutes)

Official Title
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Measuring the Effects of Different Intensities of Contact to Dogs

Conditions
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Physiological Responses to Contact With Dogs, Psychological Responses to Contact With Dogs, Behavioural Responses to Contact With Dogs

Intervention / Treatment
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* Other: Different intensities of contact to dogs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal cognitive functioning and physical movement Ability to speak and read Danish Exclusion Criteria: Known medical, psychiatric or neurological disease Use of psychotropic medications Frequent use of pain medication Use of illegal psychotropic drugs Known allergies to dogs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Randomised within-subject design. Each subject is exposed to three different levels of contact with a dog and a control situation in randomised order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ANIMAL CONTACT 1<br>Only one arm - within-subject design | Other: Different intensities of contact to dogs<br>* Each subject is exposed to four test situations of 10 minutes. Three situations with increasing intensity of dog contact, and one control test situation with no contact to a dog. The order of the test situations is random and with 30 minute washout in-between<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological measure, heart rate | The test person wears self-adhesive electrodes and the heart rate is measured non-invasively, | Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately preceeding the first test situation: t=30 minutes | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately following the first test situation: t= 40 minutes | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately preceeding the second test situation: t= 70 minutes | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately following the second test situation: t= 80 minutes | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately preceeding the third test situation: t= 110 minutes. | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately following the third test situation: t= 120 minutes. | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes. | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Test periods: Measured immediately following the fourth test situation: t=160 minutes. | 
| Physiological measure, blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | After the last resting period: Measured at the end of the last resting period, following the last of the four test situations: t= 190 minutes | 
| Physiological measure, heart rate variablility | Heart rate variability is calculated from heart rate data | Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) | 
| Physiological measure, galvanic skin response | The test person is fitted with electrodes on two fingers and galvanic skin response is measured non-invasively, | Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the first test situation: t=30 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the first test situation: t=40 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the second test situation: t=70 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the second test situation: t=80 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the third test situation: t=110 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the third test situation: t=120 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the fourth test situation: t=160 minutes. | 
| Salivary cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the first test situation: t=30 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the first test situation: t= 40 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the second test situation: t= 70 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the second test situation: t= 80 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the third test situation: t= 110 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the third test situation: t= 120 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately preceeding the fourth test situation: 150 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Test periods: Measured immediately following the fourth test situation: t=160 minutes. | 
| Salivary oxytocin | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes | 
| Visual analogue scales measuring expected psychological and physiological effects of the test day including, including all four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately preceeding the first test situation: t=30 minutes | 
| Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately preceeding the second test situation: t= 70minutes | 
| Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately preceeding the third test situation: t= 110 minutes | 
| Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately following the first test situations: t=40 minutes | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately following the second test situation: t= 80 minutes | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately following the third test situation: t=120 minutes | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Test periods: Measured immediately following the fourth test situation: t= 160 minutes | 
| Visual analogue scales measuring perceived psychological and physiological effects of of the test day including, including all four test situations | Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes | 
| The State-Trait Anxiety Inventory (STAI) | State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level) | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| The State-Trait Anxiety Inventory (STAI) | State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level) | Test periods: Measured immediately following the first test situation: t=40 minutes | 
| The State-Trait Anxiety Inventory (STAI) | State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level) | Test periods: Measured immediately following the second test situation: t= 80 minutes | 
| The State-Trait Anxiety Inventory (STAI) | State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level) | Test periods: Measured immediately following the third test situation: t= 120 minutes | 
| The State-Trait Anxiety Inventory (STAI) | State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level) | Test periods: Measured immediately following the fourth test situation: t= 160 minutes | 
| The Positive and Negative Affect Schedule (PANAS) | Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from very little /not at all to extremely much. The emotions differ in valens. | Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes) | 
| The Positive and Negative Affect Schedule (PANAS) | Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from very little /not at all to extremely much. The emotions differ in valens. | Test periods: Measured immediately following the first test situation: t= 40 minutes | 
| The Positive and Negative Affect Schedule (PANAS) | Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from very little /not at all to extremely much. The emotions differ in valens. | Test periods: Measured immediately following the second test situation: t= 80 minutes | 
| The Positive and Negative Affect Schedule (PANAS) | Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from very little /not at all to extremely much. The emotions differ in valens. | Test periods: Measured immediately following the third test situation: t=120 minutes | 
| The Positive and Negative Affect Schedule (PANAS) | Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from very little /not at all to extremely much. The emotions differ in valens. | Test periods: Measured immediately following the fourth test situation: t=160 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present | Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) | 
| Quantitative behavioural measures - duration of behavioural elements | A video recording of the test persons behaviour is analysed for the duration (seconds) of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present | Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive measure, Human-animal contact, Animal-assisted therapy