Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000852954
Ethics application status
Approved
Date submitted
5/05/2020
Date registered
27/08/2020
Date last updated
27/08/2020
Date data sharing statement initially provided
27/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Animal-Assisted Therapy in the Intensive Care Unit
Scientific title
Effect of Animal-Assisted Therapy on patient anxiety in the Intensive Care Unit
Secondary ID [1] 301195 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AAT ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 317340 0
Pain 317341 0
Condition category
Condition code
Mental Health 315448 315448 0 0
Anxiety
Public Health 315726 315726 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study utilises a prospective, single center, observational cohort survey design.

Potential participants will be screened using ‘Metavision’ (the ICU online patient portal system) to determine patient eligibility. Eligible patients are those who have been admitted longer than 72 hours and likely to stay within the ICU for a further 24 hours. Screening will occur prior to the therapy dog visit, with researchers assessing patient eligibility. Visitation of the therapy dogs is scheduled to occur weekly, with the specific day depending on the availability of the Delta volunteer.
Eligible patients and family members (as determined by the inclusion/exclusion criteria) will be invited to participate in the research. Participant involvement will be voluntary, and completion of the assessment tools will be taken as consent. The participant will be given an explanation of the study by the researcher, provided with the Participant Information Sheet and asked if they wish to be involved. Participants agreeing to be involved in the study will be asked to complete the Visual Analogue Scale for Anxiety (VAS-A) prior to the therapy dog visit, and immediately after the therapy dog visit occurs. Researchers, or the bedside nurse, will assist participants in completing the scale where required. Participants will continue to have weekly therapy dog visits and will be required to complete the VAS-A each week, prior to and after the therapy dog visit until discharge from ICU or up to 90 days. Patient care will not be affected and all procedures and care will be able to continue as normal.

In addition to the VAS-A, the patients will be asked to complete the Numerical Pain Rating Scale. A CRF has been created to collect a de-identified data set of patients, which consists of questions regarding to age, sex, length of ICU stay, ventilation status (ventilated/not ventilated), heart rate, blood pressure, respiratory rate and minute ventilation; sedation and analgesia requirements and pain score. The physiological assessment will be recorded on the CRF pre and post the therapy dog visit. It is important to note that this physiological data is routinely and continuously monitored for all ICU patients. A CRF has been created for family members to identify their age, sex and length of stay for their family member.

The Canberra Health Services ICU has a service agreement with the Delta therapy dog organisation. There are 4 service agreements with 4 Delta dog teams that visit the ICU. There are weekly visits where the team will visit for a duration of 1.5 hours. The handler will be present with the dog at all times. The handlers have all had orientation to ICU and are approved to visit in ICU by the Canberra Health service volunteer and infrastructure program. They are accompanied by one of the research team members, where the data is collected. The patients and families are screened before the visit to assess eligibility. The dog visits the patient and family at the bedside where the visit generally takes an average of 15-20 minutes or what the patient can tolerate.

The Delta Therapy dog program in the Canberra Health Services ICU was set up prior to the study commencing. Therefore, participants would have received a visit from the Delta dog team in the absence of this study.
Intervention code [1] 317498 0
Not applicable
Comparator / control treatment
Patient acts as their own control, pre and post exposure to AAT intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323695 0
To compare anxiety levels in ICU patients prior to and after the therapy dog visit. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A) within two hours pre-exposure and immediately post exposure to each weekly Animal Assisted Therapy Intervention.
Timepoint [1] 323695 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Primary outcome [2] 323936 0
To compare anxiety levels in Family members of ICU patients prior to and after the therapy dog visits. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A) within two hours pre-exposure and immediately post exposure to each weekly Animal Assisted Therapy Intervention.
Timepoint [2] 323936 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [1] 382644 0
To assess whether the change in level of anxiety experienced is sustained in long term patients (admission over 72 hours) who have received multiple therapy dog visits throughout their ICU stay. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A) within two hours pre-exposure and immediately post exposure to each weekly Animal Assisted Therapy Intervention.

Timepoint [1] 382644 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [2] 382645 0
To assess physiological change in patients pain level using the Numerical pain rating scale (0/10) within two hours pre-exposure and immediately post exposure to each weekly Animal Assisted Therapy Intervention.
Timepoint [2] 382645 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [3] 383370 0
To assess whether the change in level of anxiety experienced is sustained in family of long term patients (admission over 72 hours) who have received multiple therapy dog visits throughout their ICU stay. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety (VAS-A) within two hours pre-exposure and immediately post exposure to each weekly Animal Assisted Therapy Intervention.
Timepoint [3] 383370 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and the depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [4] 383839 0
To assess physiological change in the patients vital signs from the monitor using Metavision, the ICU Clinical Information System. The vital signs include Blood pressure, Heart rate, Respiratory Rate, Minute Ventilation.
Timepoint [4] 383839 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [5] 383842 0
The outcome being assessed is if a Delta therapy dog visitation will change the level of sedation that a patient required. The sedative medication prescribed and running will be directly observed within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and then depending on the availability of Delta Therapy dog volunteer team.
The sedation running before a visit will be recorded in meta-vision. We will document the sedation running before a visit and post a visit from Meta vision.
Timepoint [5] 383842 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and depending on the availability of the Delta Therapy dog volunteer team.
Secondary outcome [6] 383843 0
The outcome being assessed is if a Delta therapy dog visitation will change the level of analgesia that a patient required. The analgesia medication prescribed and running will be directly observed within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and then depending on the availability of Delta Therapy dog volunteer team.
The analgesia running before a visit will be recorded in meta-vision. We will document the analgesia running before a visit and post a visit from Meta vision.
Timepoint [6] 383843 0
Within two hours pre exposure and immediately post exposure to each weekly Animal Assisted Therapy intervention until discharge from ICU and the depending on the availability of the Delta Therapy dog volunteer team.

Eligibility
Key inclusion criteria
Patient Participant Inclusion Criteria
• Happy for a therapy dog visit
• 18 years and over
• Admission over 72 hours ago
• Conscious and co-operative with a RASS score of 0-1
• Able to communicate verbally or non-verbally
• Understand English


Family Member Participant Inclusion Criteria
• Happy for a therapy dog visit
• 18 years and over
• Has a family member admitted into the ICU over 72 hours ago
• Family member interested in a dog visit
• Able to communicate verbally or non-verbally
• Understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient Participant Exclusion Criteria
• Allergies to dogs
• Phobias / fear of dogs
• Patients with burns
• Open wounds
• Recent splenectomy
• Immunosuppressed patients
• Neutropenic patients
• Delirious or aggressive patients
• Patients with planned procedures during the therapy dog visit

Family Member Participant Exclusion Criteria
• Allergies to dogs
• Phobias / fear of dogs

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Study Population
The setting for the trial will be in the Canberra Hospital ICU. The Delta Therapy dog visitations will take place at the patient bedside or the ICU balcony. The ICU balcony is an external, covered space that is fully equipped for ventilated patients and is accessible from the ICU. We aim to recruit 80-100 patients and 80-100 family members within a six-month timeframe. This number is realistic for this study as the therapy dog’s visit on average 5-10 patients per week. This number takes into consideration the Delta Therapy Dog visitation guidelines that the dog must not exceed a 1.5-hour visit. Canberra Hospital ICU currently has funding (independent of this research) for 1 visit from a therapy dog per week.

Data Analysis
Key categorical and ordinal variables will be reported using frequencies and proportions. Continuous variable will be reported using means or medians and standard deviations (SD). Categorical variables will be compared using the chi-square or exact Fisher test. Continuous variables will be compared using t-tests or Mann-Whitney U tests. Univariate logistic regression will be used to determine predictors (age, sex, length of ventilation) of decrease in anxiety and pain scores. Statistical analysis will be performed using SPSS version 25.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
16/03/2019
Date of last participant enrolment
Anticipated
Actual
16/02/2020
Date of last data collection
Anticipated
Actual
16/02/2020
Sample size
Target
200
Accrual to date
131
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 16604 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 30201 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 305644 0
Other Collaborative groups
Name [1] 305644 0
SYNERGY Nursing and Midwifery Research Centre
Country [1] 305644 0
Australia
Funding source category [2] 305646 0
Government body
Name [2] 305646 0
Canberra Health Services Research Executive Committee
Country [2] 305646 0
Australia
Primary sponsor type
Other Collaborative groups
Name
SYNERGY Nursing and Midwifery research centre
Address
Building 6, Level 3, Hospital Road, Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 306050 0
Government body
Name [1] 306050 0
Canberra Health Services Intensive Care Research Executive Committee
Address [1] 306050 0
Building 12, Level 3, Canberra Hospital, Yamba Drive, Garran, ACT 2605
Country [1] 306050 0
Australia
Other collaborator category [1] 281339 0
Individual
Name [1] 281339 0
Clare Robertson
Address [1] 281339 0
Canberra Health Services Hospital Road, Garran, ACT 2605
Country [1] 281339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305930 0
The ACT Health Human Research Ethics Committee
Ethics committee address [1] 305930 0
Ethics committee country [1] 305930 0
Australia
Date submitted for ethics approval [1] 305930 0
Approval date [1] 305930 0
12/03/2019
Ethics approval number [1] 305930 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102106 0
Mrs Kathleen Cook
Address 102106 0
Building 12, Level 3, Intensive Care Unit, Canberra Hospital, Yamba Drive, Garran, ACT 2605
Country 102106 0
Australia
Phone 102106 0
+61 0408842551
Fax 102106 0
Email 102106 0
[email protected]
Contact person for public queries
Name 102107 0
Kathleen Cook
Address 102107 0
Building 12, Level 3, Intensive Care Unit, Canberra Hospital, Yamba Drive, Garran, ACT 2605
Country 102107 0
Australia
Phone 102107 0
+61 0408842551
Fax 102107 0
Email 102107 0
[email protected]
Contact person for scientific queries
Name 102108 0
Kathleen Cook
Address 102108 0
Building 12, Level 3, Intensive Care Unit, Canberra Hospital, Yamba Drive, Garran, ACT 2605
Country 102108 0
Australia
Phone 102108 0
+61 0408842551
Fax 102108 0
Email 102108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Basic demographics
Individual outcome measures
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses and case by case basis
How or where can data be obtained?
Access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7858Study protocol    379762-(Uploaded-05-05-2020-15-21-31)-Study-related document.pdf
7860Ethical approval    379762-(Uploaded-05-05-2020-15-21-49)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.