Measuring Effects of Contact to Dogs

• ClinicalTrials.gov Identifier: NCT04696419
• Recruitment Status: Completed
• First Posted: January 6, 2021
• Last Update Posted: November 10, 2021
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief 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 control condition while obtaining measures of both physiological, behavioral, and psychological effects.

Condition or disease	Intervention/treatment	Phase
Physiological Responses to Contact With Dogs; Psychological Responses to Contact With Dogs; Behavioural Responses to Contact With Dogs	Other: Different intensities of contact to dogs	Not Applicable

Detailed Description:

Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact:

1) visual (V), 2) tactile and visual (TV), 3) tactile, visual, interaction (TVI), and 4)control (C).

The participants will be subjected to all four test situations on the same day, and will be randomly allocated to test order.

On the test day, we collect background information and baseline measures for the participants (baseline period, duration: 50 minutes), whereafter they rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the four test situations (10 minutes each) that are followed by rest intervals (30 minutes each).

The participants' interaction with the dog during the 10-minute test situations are standardised according to the specific contact treatment. Most physiological and all behavioural measures are recorded continuously throughout each test in order for us to link the "dosage" of dog (the different levels of contact) with the psychological responses and some physiological measures obtained before an after each test situation.

Below is shown the exact time schedule of the test day, that we refer to when describing the outcome measures. The baseline period (30 minutes) is not included in the total test period (total duration= 190 minutes), that consist of a pre-intervention and intervention period.

• Baseline period (50 minutes - not part of total test period)
• Pre-intervention period (start, t=0 minutes; end t= 30 minutes)
• Test situation 1 (start, t=30 minutes; end, t=40 minutes)
• Rest period 1 (start, t=40 minutes, end, t= 70 minutes)
• Test situation 2 (start, t=70 minutes; end, t=80 minutes)
• Rest period 2 (start, t=80 minutes, end, t= 110 minutes)
• Test situation 3 (start, t=110 minutes; end, t=120 minutes)
• Rest period 3 (start, t=120 minutes, end, t= 150 minutes)
• Test situation 4 (start, t=150 minutes; end, t=160 minutes)
• Rest period 4 (start, t=160 minutes, end, t= 190 minutes)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Basic Science
• Official Title: Measuring the Effects of Different Intensities of Contact to Dogs
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: October 1, 2021
• Actual Study Completion Date: October 1, 2021

Arms and Interventions

Arm	Intervention/treatment
ANIMAL CONTACT 1; Only one arm - within-subject design	Other: Different intensities of contact to dogs; 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

Outcome Measures

Primary Outcome Measures :

1. 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,
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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,
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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
23. 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
24. 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
25. 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
26. 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
27. 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
28. 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
29. 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
30. 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
31. 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
32. 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
33. 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
34. 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.
35. 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.
36. 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.
37. 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.
38. 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.
39. 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.
40. 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.
41. 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.
42. 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.
43. 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.
44. 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)
45. 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)
46. 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)
47. 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)
48. 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)
49. 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.
50. 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.
51. 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.
52. 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.
53. 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.

Secondary Outcome Measures :

1. Quantitative behavioural measures - frequencies of behavioural elements [ Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) ]
   A video recording of the test persons behaviour is analysed for frequency of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present
2. Quantitative behavioural measures - duration of behavioural elements [ Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods) ]
   A video recording of the test persons behaviour is analysed for the duration (seconds) of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Normal cognitive functioning and physical movement
• Ability to speak and read Danish

Exclusion Criteria:

• Known medical, psychiatric or neurological disease
• Use of psychotropic medications
• Frequent use of pain medication
• Use of illegal psychotropic drugs
• Known allergies to dogs

Contacts and Locations

Locations

Denmark

Aarhus University

Tjele, Denmark, DK-8830

Sponsors and Collaborators

University of Aarhus

Investigators

• Principal Investigator: Karen Thodberg; Senior researcher

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04696419
• Other Study ID Numbers: ANIMAL CONTACT1; 128534 ( Other Grant/Funding Number: TrygFonden )
• First Posted: January 6, 2021
• Last Update Posted: November 10, 2021
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

Animal-assisted therapy; Non-invasive measure; Human-animal contact