Effects of Contact to Dogs During Stressful Situations

NCT ID: NCT04866173

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-10-17

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.

Detailed Description

The study design is a randomised controlled crossover design, nested within two groups - one with a dog present (Dog) and another without a dog present (No Dog). Both groups will be subjected to a classical stress test - the Maastricht Acute Stress Test (MAST) and a pain test with periods of relaxation in between. The participants will be subjected to both test situations on the same day and in the same order.

On the test day, background information and baseline measures (baseline period, duration: 40 minutes) will be collected, whereafter the participants rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the two test situations, pain test (60 minutes, including calibration and two separate tests sessions) and MAST (15 minutes, including 5 min introduction) with 30 minutes of relaxation in between and a 40 min post-rest period The participants' interaction with the dog is recorded using quantitative behaviour sampling using predefined behavioural categories.

Most physiological and all behavioural measures are recorded continuously throughout test situations and relaxation, in order to be able to study the response to the stress situations and recovery, and the response to contact with dog, and to psychological responses. Some physiological measures obtained before and after each test situation.

Below the exact time schedule of the test day is shown and these times will be refered to when the outcome measures are described. The "Baseline period" (40 minutes) and the last 10 minutes where the equipment for physiological measures is removed is not included in the duration of the test period (174 minutes). All times are given in minutes.

Baseline period (40 minutes - not part of total test period)

• Pre-intervention period (start t = 0; end t = 30)
• Calibration for pain test (start t = 30, end t = 35)
• Rest period 1 (start t = 35, end t = 47)
• Pain test 1 (start t = 47, end t = 52)
• Post-pain test 1 (start t = 52, end, t= 62)
• Rest period 2 (start t = 62, end t = 74)
• Pain test 2 (start t = 74, end t = 79)
• Post-pain test 2 (start t = 79, end t = 89)
• Rest period 3 (start t = 89, end t = 119)
• MAST test (incl. introduction (start t = 119, end t = 134)
• Rest period 4 (start t = 134, end t = 174)

Conditions

Physiological Stress Responses to Standardises Stress Situations; Psychological Responses to Standardised Stress Situations; Behavioural Responses to Standardised Stress Situations

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dog

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

Group Type: EXPERIMENTAL

Dog

Intervention Type: OTHER

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

No Dog

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

Group Type: EXPERIMENTAL

No Dog

Intervention Type: OTHER

Subjection to standardised stress situations in the presence of a person

Interventions

Dog

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

Intervention Type: OTHER

No Dog

Subjection to standardised stress situations in the presence of a person

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Thodberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Aarhus University

Tjele, , Denmark

Countries

Denmark

Other Identifiers

128534

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ANIMAL CONTACT2

Identifier Type: -

Identifier Source: org_study_id