Effects of Contact to Dogs During Stressful Situations

Study Overview
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Brief Summary
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The investigators will conduct an experimental study comparing responses of healthy participants in two test situations where they are subjected to mild stress. The study design is a randomised controlled crossover design nested within two groups - one with a dog present and another without a dog present. The participants will be randomly allocated to two groups (with dog and without dog) and the participants will receive both test situations on the same day. During the two test situations the participants will be subjected to a classical stress test , and exposed to tolerable pain, as well as periods with relaxation.

Detailed Description
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The study design is a randomised controlled crossover design, nested within two groups - one with a dog present (Dog) and another without a dog present (No Dog). Both groups will be subjected to a classical stress test - the Maastricht Acute Stress Test (MAST) and a pain test with periods of relaxation in between. The participants will be subjected to both test situations on the same day and in the same order. On the test day, background information and baseline measures (baseline period, duration: 40 minutes) will be collected, whereafter the participants rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the two test situations, pain test (60 minutes, including calibration and two separate tests sessions) and MAST (15 minutes, including 5 min introduction) with 30 minutes of relaxation in between and a 40 min post-rest period The participants' interaction with the dog is recorded using quantitative behaviour sampling using predefined behavioural categories. Most physiological and all behavioural measures are recorded continuously throughout test situations and relaxation, in order to be able to study the response to the stress situations and recovery, and the response to contact with dog, and to psychological responses. Some physiological measures obtained before and after each test situation. Below the exact time schedule of the test day is shown and these times will be refered to when the outcome measures are described. The Baseline period (40 minutes) and the last 10 minutes where the equipment for physiological measures is removed is not included in the duration of the test period (174 minutes). All times are given in minutes. Baseline period (40 minutes - not part of total test period) Pre-intervention period (start t = 0; end t = 30) Calibration for pain test (start t = 30, end t = 35) Rest period 1 (start t = 35, end t = 47) Pain test 1 (start t = 47, end t = 52) Post-pain test 1 (start t = 52, end, t= 62) Rest period 2 (start t = 62, end t = 74) Pain test 2 (start t = 74, end t = 79) Post-pain test 2 (start t = 79, end t = 89) Rest period 3 (start t = 89, end t = 119) MAST test (incl. introduction (start t = 119, end t = 134) Rest period 4 (start t = 134, end t = 174)

Official Title
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Effects of Contact to a Dog During Standardised Stressful Situations

Conditions
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Physiological Stress Responses to Standardises Stress Situations, Psychological Responses to Standardised Stress Situations, Behavioural Responses to Standardised Stress Situations

Intervention / Treatment
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* Other: Dog
* Other: No Dog


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dog<br>Being subjected to two standardised stress situations with a dog and its handler present | Other: Dog<br>* Subjection to standardised stress situations in the presence of a dog and a person<br>|
| Experimental: No Dog<br>Being subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler) | Other: No Dog<br>* Subjection to standardised stress situations in the presence of a person<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 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured at the end of the 30 minute pre-intervention period (t=30 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured at the end of Rest Period 1 (t=47 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured after Pain test 1 (t=52 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured at the end of Rest period 2 (t=74 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured after Pain test 2 (t=79 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured at the end of Rest period 3 (t=119 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Measured after MAST test (t=134 minutes)] | 
| Physiological measure, systolic and diastolic blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff. | Measured after Rest period 4 (t=174 minutes)] | 
| Physiological measure, heart rate variability | Heart rate variability is calculated from heart rate data. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| 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 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute. | Measured at the end of the 30 minute pre-intervention period (t=30 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured at the end of Rest Period 1 (t=47 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured after Post-pain test 1 (t=62 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured at the end of Rest period 2 (t=74 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured after Post-pain test 2 (t=89 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured at the end of Rest period 3 (t=119 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured after MAST test (t=134 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured 5 minutes after MAST test (t=139 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured 10 minutes after MAST test (t=144 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured 20 minutes after MAST test (t=154 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured 30 minutes after MAST test (t=164 minutes)] | 
| Salivary cortisol | Saliva is obtained from the test subject with a cotton swab which is chewed for one minute | Measured 40 minutes after MAST test (t=174 minutes)] | 
| Visual analogue scales measuring expected psychological and physiological effects of the test day including, including the two test situation and the rest periods | Test persons fill in a visual analogue 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 (t=0 minutes)] | 
| Visual analogue scales measuring expected psychological and physiological effects of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | : Measured immediately preceding Pain test 1 (t=47 minutes] | 
| Visual analogue scales measuring expected psychological and physiological effects of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | : Measured immediately preceding Pain test 2 (t=74 minutes] | 
| Visual analogue scales measuring expected psychological and physiological effects of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | : Measured immediately preceding MAST test (t=119 minutes] | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Measured immediately following Pain test 1(t=52 minutes) | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Measured immediately following Pain test 2 (t=79 minutes) | 
| Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Measured immediately following MAST test 1 (t=134 minutes) | 
| Visual analogue scales measuring perceived psychological and physiological effects of of the test day including the test situations and rest period | Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral. | Measured immediately after Rest period 4 (t=174 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 preceding the first test situation (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) | Measured immediately following Pain test 1 (t= 52 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) | Measured immediately following Pain test 2 (t= 79 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) | Measured immediately following MAST test 1 (t=134 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) | Measured immediately after Rest period 4 (t=174 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 preceding the first test situation (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. | Measured immediately following Pain test 1 (t= 52 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. | Measured immediately following Pain test 2 (t= 79 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. | Measured immediately following MAST test 1 (t=134 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. | Measured immediately after Rest period 4 (t=174 minutes) | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of sitting. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of standing. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of walking. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of touching the dog (being in physical contact with the dog with the hand or another part of the body, only in the arm: Dog) | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of looking at the dog (having the head turned towards the dog, only in the arm: Dog). | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)] | 
| Quantitative behavioural measures - frequencies of behavioural elements | A video recording of the test persons behaviour is analysed for frequency of talking to the dog (Only in the arm: Dog). | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 sitting. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 standing. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 walking. | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 touching the dog (being in physical contact with the dog with the hand or another part of the body, only in the arm: Dog). | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 looking at the dog (having the head turned towards the dog, only in the arm: Dog). | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 talking to the dog (Only in the arm: Dog). | Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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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Human-animal contact, Non-invasive measure, Animal-assisted contact