Measuring Effects of Contact to Dogs

NCT04696419 | Completed

• 2 other identifiers: ANIMAL CONTACT1128534
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (53)

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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.

• 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.

• 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.

• 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.

• 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

• 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)

• 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)

• 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)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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 Outcomes (2)

• Quantitative behavioural measures - frequencies of behavioural elements

  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

  Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)

Study Arms (1)

ANIMAL CONTACT 1

OTHER

Only one arm - within-subject design

Other: Different intensities of contact to dogs

Interventions

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

ANIMAL CONTACT 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Tjele, DK-8830, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39217835 DERIVED

Study Officials

• Karen Thodberg

  Senior researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised within-subject design. Each subject is exposed to three different levels of contact with a dog and a control situation in randomised order.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: January 6, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)