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Completed

NCT Number: NCT04696419

Measuring Effects 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.

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Key information

Conditions

Physiological Responses to Contact With Dogs Behavioural Responses to Contact With Dogs Psychological Responses to Contact With Dogs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Tjele, DK-8830, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Different intensities of contact to dogs

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Measuring the Effects of Different Intensities of Contact to Dogs

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.