An interventional study of Dog and No Dog in Physiological Stress Responses to Standardises Stress Situations, Psychological Responses to Standardised Stress Situations and Behavioural Responses to Standardised Stress Situations, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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.
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)
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Being subjected to two standardised stress situations with a dog and its handler present
Other: Dog
Being subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler)
Other: No Dog
Subjection to standardised stress situations in the presence of a dog and a person
Subjection to standardised stress situations in the presence of a person
Physiological measure, heart rate
The test person wears self-adhesive electrodes and the heart rate is measured non-invasively
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Measured after Rest period 4 (t=174 minutes)]
Physiological measure, heart rate variability
Heart rate variability is calculated from heart rate data.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: : 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.
Time frame: : 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.
Time frame: : 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)]
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus