Behavioural and Physiological Responses to Dog Visits in Nursing Homes

May 7, 2024 updated by: University of Aarhus
In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The residents will receive six 10-minute visits, three visits with a dog and three without a dog, with a week-long break in between the two visit types. The participants will be randomly assigned to receive either the three dog visits or the three visits without a dog first. The visits will be from the same person, and the dog visits will be accompanied with the same dog each time. During dog visits, the dog will be available for touch, and the resident will be encouraged to interact with the dog.

Before each visit the resident is fitted with the equipment for measuring continuously recorded physiological measures and then relaxes for 30 minutes. Immediately before and five and 30 minutes after each visit, the investigators obtain a saliva sample to detect cortisol levels.

The behaviour of the participants will be video recorded during the visits to quantify the frequency and duration of predefined behavioural elements, using ethological methodology. The investigators will quantify the participants' activity during the visits as well as the frequency and duration of tactile contact with the dog, and verbal communication with the dog and the visitor.

In addition, the visitor and the observer present during the visit will subjectively assess the resident's perception of the visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Højslev, Denmark, 7840
        • Karen Thodberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age of 65 years or more
  • Able to sit during visits (either in a chair or in a bed)

Exclusion Criteria:

  • Known allergy to dogs
  • Known fear of dogs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Dog visits first
Participants receive the three dogs visits first and then, after a break, receive the three control visits
Behavioral: Dog visits/control visits
See arm description above
Other: Control visits first
Participants receive the three control visits first and then, after a break, receive the three dog visits
Behavioral: Control visits/dog visits
See arm description above

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate
Time Frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate
Time Frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate
Time Frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate
Time Frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate
Time Frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
The test person wears a device placed on the upper arm
During visit no. 6, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 1, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 2, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 3, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 4, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 5, from 30 minutes before the visit to 30 minutes after
Heart rate variability
Time Frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
Heart rate variability is calculated from heart rate data
During visit no. 6, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 1, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 1, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 2, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 2, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 3, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 3, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 4, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 4, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 5, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 5, from 30 minutes before the visit to 30 minutes after
Behaviour during visits
Time Frame: During visit no. 6, from 30 minutes before the visit to 30 minutes after
The test persons behaviour is observed
During visit no. 6, from 30 minutes before the visit to 30 minutes after
Salivary cortisol
Time Frame: Visit 1, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 1, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 2, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 2, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 3, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 3, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 4, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 4, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 5, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 5, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 6, 2 minutes before visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 6, 2 minutes before visit
Salivary cortisol
Time Frame: Visit 1, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 1, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 2, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 2, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 3, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 3, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 4, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 4, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 5, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 5, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 6, 5 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 6, 5 minutes after visit
Salivary cortisol
Time Frame: Visit 1, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 1, 30 minutes after visit
Salivary cortisol
Time Frame: Visit 2, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 2, 30 minutes after visit
Salivary cortisol
Time Frame: Visit 3, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 3, 30 minutes after visit
Salivary cortisol
Time Frame: Visit 4, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 4, 30 minutes after visit
Salivary cortisol
Time Frame: Visit 5, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 5, 30 minutes after visit
Salivary cortisol
Time Frame: Visit 6, 30 minutes after visit
Saliva is obtained from the testperson with a swab which held his/her mouth for one minute
Visit 6, 30 minutes after visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 1
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 1
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 2
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 2
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 3
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 3
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 4
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 4
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 5
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 5
The visitor's and observer's perception of how the visit was experienced by the test person.
Time Frame: 5 minutes after visit 6
Minimum value 0 (worst possible visit) to 100 (best possible visit)
5 minutes after visit 6
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 1
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 1
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 2
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 2
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 3
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 3
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 4
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 4
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 5
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 5
Visual analoque scale of the testpersons' evaluation of the visit
Time Frame: 5 minutes after visit 6
Minimum value 0 (worst possible experience) to 100 (best possible experience)
5 minutes after visit 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANIMAL CONTACT 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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