NCT04866173

Brief Summary

The investigators will conduct an experimental study comparing responses of healthy participants in two test situations where they are subjected to mild stress. The study design is a randomised controlled crossover design nested within two groups - one with a dog present and another without a dog present. The participants will be randomly allocated to two groups (with dog and without dog) and the participants will receive both test situations on the same day. During the two test situations the participants will be subjected to a classical stress test , and exposed to tolerable pain, as well as periods with relaxation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

November 10, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 14, 2021

Last Update Submit

November 9, 2021

Conditions

Physiological Stress Responses to Standardises Stress SituationsPsychological Responses to Standardised Stress SituationsBehavioural Responses to Standardised Stress Situations

Keywords

Human-animal contactNon-invasive measureAnimal-assisted 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 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured at the end of Rest Period 1 (t=47 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured after Pain test 1 (t=52 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured at the end of Rest period 2 (t=74 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured after Pain test 2 (t=79 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured at the end of Rest period 3 (t=119 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

    Measured after MAST test (t=134 minutes)]

  • Physiological measure, systolic and diastolic blood pressure

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

    Measured after Rest period 4 (t=174 minutes)]

  • Physiological measure, heart rate variability

    Heart rate variability is calculated from heart rate data.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • 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 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute.

    Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured at the end of Rest Period 1 (t=47 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured after Post-pain test 1 (t=62 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured at the end of Rest period 2 (t=74 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured after Post-pain test 2 (t=89 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured at the end of Rest period 3 (t=119 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured after MAST test (t=134 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured 5 minutes after MAST test (t=139 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured 10 minutes after MAST test (t=144 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured 20 minutes after MAST test (t=154 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured 30 minutes after MAST test (t=164 minutes)]

  • Salivary cortisol

    Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

    Measured 40 minutes after MAST test (t=174 minutes)]

  • Visual analogue scales measuring expected psychological and physiological effects of the test day including, including the two test situation and the rest periods

    Test persons fill in a visual analogue 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 (t=0 minutes)]

  • Visual analogue scales measuring expected psychological and physiological effects of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    : Measured immediately preceding Pain test 1 (t=47 minutes]

  • Visual analogue scales measuring expected psychological and physiological effects of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    : Measured immediately preceding Pain test 2 (t=74 minutes]

  • Visual analogue scales measuring expected psychological and physiological effects of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    : Measured immediately preceding MAST test (t=119 minutes]

  • Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    Measured immediately following Pain test 1(t=52 minutes)

  • Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    Measured immediately following Pain test 2 (t=79 minutes)

  • Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    Measured immediately following MAST test 1 (t=134 minutes)

  • Visual analogue scales measuring perceived psychological and physiological effects of of the test day including the test situations and rest period

    Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

    Measured immediately after Rest period 4 (t=174 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 preceding the first test situation (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 immediately following Pain test 1 (t= 52 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 immediately following Pain test 2 (t= 79 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 immediately following MAST test 1 (t=134 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 immediately after Rest period 4 (t=174 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 preceding the first test situation (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 immediately following Pain test 1 (t= 52 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 immediately following Pain test 2 (t= 79 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 immediately following MAST test 1 (t=134 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 immediately after Rest period 4 (t=174 minutes)

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of sitting.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of standing.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of walking.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of touching the dog (being in physical contact with the dog with the hand or another part of the body, only in the arm: Dog)

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of looking at the dog (having the head turned towards the dog, only in the arm: Dog).

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

  • Quantitative behavioural measures - frequencies of behavioural elements

    A video recording of the test persons behaviour is analysed for frequency of talking to the dog (Only in the arm: Dog).

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 sitting.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 standing.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 walking.

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 touching the dog (being in physical contact with the dog with the hand or another part of the body, only in the arm: Dog).

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 looking at the dog (having the head turned towards the dog, only in the arm: Dog).

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following 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 talking to the dog (Only in the arm: Dog).

    Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]

Study Arms (2)

Dog

EXPERIMENTAL

Being subjected to two standardised stress situations with a dog and its handler present

Other: Dog

No Dog

EXPERIMENTAL

Being subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler)

Other: No Dog

Interventions

DogOTHER

Subjection to standardised stress situations in the presence of a dog and a person

Dog
No DogOTHER

Subjection to standardised stress situations in the presence of a person

No Dog

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Tjele, DK-8830, Denmark

Location

Study Officials

  • Karen Thodberg, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 29, 2021

Study Start

May 1, 2021

Primary Completion

October 17, 2021

Study Completion

October 17, 2021

Last Updated

November 10, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)