- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866173
Effects of Contact to Dogs During Stressful Situations
Effects of Contact to a Dog During Standardised Stressful Situations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dog
Being subjected to two standardised stress situations with a dog and its handler present
|
Subjection to standardised stress situations in the presence of a dog and a person
|
EXPERIMENTAL: No Dog
Being subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler)
|
Subjection to standardised stress situations in the presence of a person
|
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 174 minutes (starting in the pre-intervention period and during the following 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 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
Time Frame: Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]
|
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
Time Frame: Measured at the end of Rest Period 1 (t=47 minutes)]
|
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
Time Frame: Measured after Pain test 1 (t=52 minutes)]
|
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
Time Frame: Measured at the end of Rest period 2 (t=74 minutes)]
|
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
Time Frame: Measured after Pain test 2 (t=79 minutes)]
|
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
Time Frame: Measured at the end of Rest period 3 (t=119 minutes)]
|
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
Time Frame: Measured after MAST test (t=134 minutes)]
|
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
Time Frame: Measured after Rest period 4 (t=174 minutes)]
|
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
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)]
|
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
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)]
|
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
Time Frame: Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]
|
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
Time Frame: Measured at the end of Rest Period 1 (t=47 minutes)]
|
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
Time Frame: Measured after Post-pain test 1 (t=62 minutes)]
|
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
Time Frame: Measured at the end of Rest period 2 (t=74 minutes)]
|
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
Time Frame: Measured after Post-pain test 2 (t=89 minutes)]
|
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
Time Frame: Measured at the end of Rest period 3 (t=119 minutes)]
|
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
Time Frame: Measured after MAST test (t=134 minutes)]
|
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
Time Frame: Measured 5 minutes after MAST test (t=139 minutes)]
|
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
Time Frame: Measured 10 minutes after MAST test (t=144 minutes)]
|
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
Time Frame: Measured 20 minutes after MAST test (t=154 minutes)]
|
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
Time Frame: Measured 30 minutes after MAST test (t=164 minutes)]
|
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
Time Frame: Measured 40 minutes after MAST test (t=174 minutes)]
|
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
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period (t=0 minutes)]
|
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
Time Frame: : Measured immediately preceding Pain test 1 (t=47 minutes]
|
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
Time Frame: : Measured immediately preceding Pain test 2 (t=74 minutes]
|
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
Time Frame: : Measured immediately preceding MAST test (t=119 minutes]
|
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
Time Frame: Measured immediately following Pain test 1(t=52 minutes)
|
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
Time Frame: Measured immediately following Pain test 2 (t=79 minutes)
|
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
Time Frame: Measured immediately following MAST test 1 (t=134 minutes)
|
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
Time Frame: Measured immediately after Rest period 4 (t=174 minutes)
|
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)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceding the first test situation (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 preceding the first test situation (t=0 minutes)]
|
The State-Trait Anxiety Inventory (STAI)
Time Frame: Measured immediately following Pain test 1 (t= 52 minutes)
|
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)
Time Frame: Measured immediately following Pain test 2 (t= 79 minutes)
|
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)
Time Frame: Measured immediately following MAST test 1 (t=134 minutes)
|
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)
Time Frame: Measured immediately after Rest period 4 (t=174 minutes)
|
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)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceding the first test situation (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 preceding the first test situation (t=0 minutes)]
|
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Measured immediately following Pain test 1 (t= 52 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.
|
Measured immediately following Pain test 1 (t= 52 minutes)
|
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Measured immediately following Pain test 2 (t= 79 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.
|
Measured immediately following Pain test 2 (t= 79 minutes)
|
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Measured immediately following MAST test 1 (t=134 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.
|
Measured immediately following MAST test 1 (t=134 minutes)
|
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Measured immediately after Rest period 4 (t=174 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.
|
Measured immediately after Rest period 4 (t=174 minutes)
|
Quantitative behavioural measures - frequencies of behavioural elements
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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
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)]
|
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)]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Thodberg, PhD, University of Aarhus
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 CONTACT2
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physiological Stress Responses to Standardises Stress Situations
-
University of AarhusCompletedPhysiological Responses to Contact With Dogs | Psychological Responses to Contact With Dogs | Behavioural Responses to Contact With DogsDenmark
-
University of HoustonCompletedPhysiological and Psychological Responses to ExerciseUnited States
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Centre Hospitalier Universitaire de NiceCompletedStress, Physiological
-
Texas State UniversityM. Hunter Martaindale; C. Dillard; D. GonzalezCompleted
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedPhysiological StressUnited States
-
University of UtahEnrolling by invitation
-
Ohio State UniversityCompletedStress, PhysiologicalUnited States
-
Pennington Biomedical Research CenterCompleted
-
University of Wisconsin, MadisonCompleted
Clinical Trials on Dog
-
Copenhagen Studies on Asthma in ChildhoodCompleted
-
Indiana UniversityRecruitingAnxiety | Children | Opioid Use | Therapy DogUnited States
-
Swiss Tropical & Public Health InstituteUniversity of BaselCompleted
-
University of Maryland, BaltimoreCompletedPost Traumatic Stress DisorderUnited States
-
University of Alabama at BirminghamNot yet recruitingElbow InjuryUnited States
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...UnknownBrain Injuries | Traumatic Brain Injury | Acquired Brain InjuryUnited States
-
University of AarhusRecruitingMood | Behavior | Physiological ResponsesDenmark
-
Linkoeping UniversityMinistry of Health and Social Affairs, SwedenCompletedEpilepsy | Diabetes | Impairment
-
Cairo UniversityUnknown
-
University of ArizonaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPost Traumatic Stress DisorderUnited States