Physiological Stress Responses to Standardises Stress SituationsNCT04866173
Effects of Contact to Dogs During Stressful Situations
A study testing Dog and No Dog in people with Physiological Stress Responses to Standardises Stress Situations and Psychological Responses to Standardised Stress Situations, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress Responses to Standardises Stress Situations, Psychological Responses to Standardised Stress Situations, Behavioural Responses to Standardised Stress Situations
- What is being tested?
- Dog and No Dog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 17 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal cognitive functioning and physical movement
- Ability to speak and read Danish
Who cannot join
- Known medical, psychiatric or neurological disease
- Use of psychotropic medications
- Frequent use of pain medication
- Use of illegal psychotropic drugs
- Known allergies to dogs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Contact to a Dog During Standardised Stressful Situations
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.
Read the 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)
- Conditions
- Physiological Stress Responses to Standardises Stress Situations, Psychological Responses to Standardised Stress Situations, Behavioural Responses to Standardised Stress Situations
- Being tested
- Dog, No Dog
- Keywords
- Human-animal contact, Non-invasive measure, Animal-assisted contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DogOther
Subjection to standardised stress situations in the presence of a dog and a person
No DogOther
Subjection to standardised stress situations in the presence of a person
| Study group | Role | What they receive |
|---|---|---|
| Dog | Experimental | Being subjected to two standardised stress situations with a dog and its handler present Receives: Other: Dog |
| No Dog | Experimental | Being subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler) Receives: Other: No Dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological measure, heart rate
The test person wears self-adhesive electrodes and the heart rate is measured non-invasively
Measured: 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: 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: 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: 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: 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: 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: 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: 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: Measured after Rest period 4 (t=174 minutes)]
Physiological measure, heart rate variability
Heart rate variability is calculated from heart rate data.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
Measured: 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: : 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: : 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: : 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: 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: 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: 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: 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)
Measured: 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: 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: 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: 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: 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.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 May 2021
- Primary completion17 Oct 2021
- Study completion17 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Stress Responses to Standardises Stress SituationsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Thodberg, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866173
- Sponsor's protocol ID
- ANIMAL CONTACT2
- Other IDs
- 128534
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Contact to a Dog During Standardised Stressful Situations
- ClinicalTrials.gov ID
- NCT04866173
- Acronym / sponsor ID
- ANIMAL CONTACT2
- Conditions
- Physiological Stress Responses to Standardises Stress Situations, Psychological Responses to Standardised Stress Situations, Behavioural Responses to Standardised Stress Situations
- Keywords
- Human-animal contact, Non-invasive measure, Animal-assisted contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dog | Experimental | Other: DogBeing subjected to two standardised stress situations with a dog and its handler present |
| No Dog | Experimental | Other: No DogBeing subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal cognitive functioning and physical movement
- Ability to speak and read Danish
Key exclusion criteria (5 listed)
- Known medical, psychiatric or neurological disease
- Use of psychotropic medications
- Frequent use of pain medication
- Use of illegal psychotropic drugs
- Known allergies to dogs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DogSubjection to standardised stress situations in the presence of a dog and a person | Other | Dog |
| No DogSubjection to standardised stress situations in the presence of a person | Other | No Dog |
Primary outcome
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
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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)
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).
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).
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.
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.
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.
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Thodberg, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog and No Dog in people with Physiological Stress Responses to Standardises Stress Situations and Psychological Responses to Standardised Stress Situations, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.