Measuring Effects of Contact to Dogs

Behavioural Responses to Contact With Dogs Clinical Trial

Official title:

Measuring the Effects of Different Intensities of Contact to Dogs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696419
• Other study ID #: ANIMAL CONTACT1
• Secondary ID: 128534
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University	Tjele

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological measure, heart rate	The test person wears self-adhesive electrodes and the heart rate is measured non-invasively,	Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately following the first test situation: t= 40 minutes
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately following the second test situation: t= 80 minutes
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately following the third test situation: t= 120 minutes.
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Primary	Physiological measure, blood pressure	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff	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
Primary	Physiological measure, heart rate variablility	Heart rate variability is calculated from heart rate data	Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Primary	Physiological measure, galvanic skin response	The test person is fitted with electrodes on two fingers and galvanic skin response is measured non-invasively,	Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the first test situation: t=40 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the second test situation: t=80 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the third test situation: t=120 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Primary	Salivary cortisol	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	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
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the first test situation: t= 40 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the second test situation: t= 80 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the third test situation: t= 120 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Primary	Salivary oxytocin	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute	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
Primary	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.	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	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.	Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Primary	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.	Test periods: Measured immediately preceeding the second test situation: t= 70minutes
Primary	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.	Test periods: Measured immediately preceeding the third test situation: t= 110 minutes
Primary	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.	Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes
Primary	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.	Test periods: Measured immediately following the first test situations: t=40 minutes
Primary	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.	Test periods: Measured immediately following the second test situation: t= 80 minutes
Primary	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.	Test periods: Measured immediately following the third test situation: t=120 minutes
Primary	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.	Test periods: Measured immediately following the fourth test situation: t= 160 minutes
Primary	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.	After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes
Primary	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)	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	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)	Test periods: Measured immediately following the first test situation: t=40 minutes
Primary	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)	Test periods: Measured immediately following the second test situation: t= 80 minutes
Primary	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)	Test periods: Measured immediately following the third test situation: t= 120 minutes
Primary	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)	Test periods: Measured immediately following the fourth test situation: t= 160 minutes
Primary	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.	Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Primary	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.	Test periods: Measured immediately following the first test situation: t= 40 minutes
Primary	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.	Test periods: Measured immediately following the second test situation: t= 80 minutes
Primary	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.	Test periods: Measured immediately following the third test situation: t=120 minutes
Primary	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.	Test periods: Measured immediately following the fourth test situation: t=160 minutes
Secondary	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 continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Secondary	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 continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)