- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696419
Measuring Effects of Contact to Dogs
Measuring the Effects of Different Intensities of Contact to Dogs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tjele, Denmark, DK-8830
- Aarhus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ANIMAL CONTACT 1
Only one arm - within-subject design
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological measure, heart rate
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
|
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
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
|
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
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes
|
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
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
|
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
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
|
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
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
|
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
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
|
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
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
|
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
Time Frame: 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
|
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
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
|
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
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
|
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
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
|
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
Time Frame: Test periods: Measured immediately following the first test situation: t=40 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
|
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
Time Frame: Test periods: Measured immediately following the second test situation: t=80 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
|
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
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
|
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
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
|
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
Time Frame: 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
|
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
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
|
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
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
|
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
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
|
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
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
|
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
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
|
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
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
|
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
Time Frame: 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
|
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
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
|
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
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70minutes
|
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
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes
|
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
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes
|
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
Time Frame: Test periods: Measured immediately following the first test situations: t=40 minutes
|
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
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
|
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
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes
|
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
Time Frame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
|
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
Time Frame: After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes
|
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)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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)
Time Frame: Test periods: Measured immediately following the first test situation: t=40 minutes
|
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)
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
|
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)
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes
|
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)
Time Frame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
|
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)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
|
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)
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes
|
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)
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
|
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)
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes
|
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)
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes
|
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
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
|
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
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Thodberg, Senior Researcher
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ANIMAL CONTACT1
- 128534 (Other Grant/Funding Number: TrygFonden)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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