Physiological Responses to Contact With DogsNCT04696419
Measuring Effects of Contact to Dogs
A study testing Different intensities of contact to dogs in people with Physiological Responses to Contact With Dogs and Psychological Responses to Contact With Dogs, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiological Responses to Contact With Dogs, Psychological Responses to Contact With Dogs, Behavioural Responses to Contact With Dogs
- What is being tested?
- Different intensities of contact to dogs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 1 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: Measuring the Effects of Different Intensities of Contact to Dogs
The study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog control condition while obtaining measures of both physiological, behavioral, and psychological effects.
Read the detailed description
Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact:
- 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)
- Conditions
- Physiological Responses to Contact With Dogs, Psychological Responses to Contact With Dogs, Behavioural Responses to Contact With Dogs
- Being tested
- Different intensities of contact to dogs
- Keywords
- Animal-assisted therapy, Non-invasive measure, Human-animal contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different intensities of contact to dogsOther
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
| Study group | Role | What they receive |
|---|---|---|
| ANIMAL CONTACT 1 | Other | Only one arm - within-subject design Receives: Other: Different intensities of contact to dogs |
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 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: 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
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately following the first test situation: t= 40 minutes
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately following the second test situation: t= 80 minutes
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately following the third test situation: t= 120 minutes.
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Physiological measure, blood pressure
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Measured: 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
Heart rate variability is calculated from heart rate data
Measured: 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
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 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the first test situation: t=40 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the second test situation: t=80 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the third test situation: t=120 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Salivary cortisol
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: 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
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the first test situation: t= 40 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the second test situation: t= 80 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the third test situation: t= 120 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Salivary oxytocin
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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 preceeding the first of the four test situations (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: Test periods: Measured immediately following the first test situation: t=40 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: Test periods: Measured immediately following the second test situation: t= 80 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: Test periods: Measured immediately following the third test situation: t= 120 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: Test periods: Measured immediately following the fourth test situation: t= 160 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 preceeding the first of the four test situations (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: Test periods: Measured immediately following the first test situation: t= 40 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: Test periods: Measured immediately following the second test situation: t= 80 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: Test periods: Measured immediately following the third test situation: t=120 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: Test periods: Measured immediately following the fourth test situation: t=160 minutes
Secondary outcomes (2)
Quantitative behavioural measures - frequencies of behavioural elements
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: 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
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: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four 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 posted6 Jan 2021
- Study start1 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological Responses to Contact With DogsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Randomised within-subject design. Each subject is exposed to three different levels of contact with a dog and a control situation in randomised order.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Thodberg, Principal investigator, Senior researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696419
- Sponsor's protocol ID
- ANIMAL CONTACT1
- Other IDs
- 128534
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuglsang-Damgaard LH, Lunde SJ, Christensen JW, Vase L, Videbech PB, Thodberg K. Human physiological responses to different types of human-dog interactions: A randomised crossover study. Complement Ther Clin Pract. 2024 Nov;57:101899. doi: 10.1016/j.ctcp.2024.101899. Epub 2024 Aug 26.
PubMed 39217835
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
- Measuring the Effects of Different Intensities of Contact to Dogs
- ClinicalTrials.gov ID
- NCT04696419
- Acronym / sponsor ID
- ANIMAL CONTACT1
- Conditions
- Physiological Responses to Contact With Dogs, Psychological Responses to Contact With Dogs, Behavioural Responses to Contact With Dogs
- Keywords
- Animal-assisted therapy, Non-invasive measure, Human-animal contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 6 Jan 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 study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog control condition while obtaining measures of both physiological, behavioral, and psychological effects.
Detailed description
Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomised within-subject design. Each subject is exposed to three different levels of contact with a dog and a control situation in randomised order.
| Arm | Type | Receives |
|---|---|---|
| ANIMAL CONTACT 1 | Other | Other: Different intensities of contact to dogsOnly one arm - within-subject design |
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 |
|---|---|---|
| Different intensities of contact to dogsEach 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 | Other | ANIMAL CONTACT 1 |
Primary outcome
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,
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
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
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
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
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
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
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
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
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
2 secondary outcomes
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)
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)
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.
- Derived from this study: PubMed 39217835Fuglsang-Damgaard LH, Lunde SJ, Christensen JW, Vase L, Videbech PB, Thodberg K. Human physiological responses to different types of human-dog interactions: A randomised crossover study. Complement Ther Clin Pract. 2024 Nov;57:101899. doi: 10.1016/j.ctcp.2024.101899. Epub 2024 Aug 26.
- 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 principal investigator
Senior researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different intensities of contact to dogs in people with Physiological Responses to Contact With Dogs and Psychological Responses to Contact With Dogs, 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 190 minutes (through the pre-intervention period, the four 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?
On the ClinicalTrials.gov record for NCT04696419, which also lists 1 linked publication.
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.