Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000041752
Ethics application status
Approved
Date submitted
1/12/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a novel approach to managing dry mouth in palliative care
Scientific title
Effectiveness of mini mint ice cubes on the thirst intensity, thirst-related distress, and perceptions of dry mouth in palliative care patients
Secondary ID [1] 305950 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Mouth 324547 0
Palliative Care 324548 0
Condition category
Condition code
Oral and Gastrointestinal 322014 322014 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To demonstrate the efficacy of mini mint ice cubes in relieving perceptions of thirst and dry mouth for patients receiving specialist palliative care.
The participants will be offered usual mouth care (including mouth swabs and lip balm with plain water ice cubes) or the intervention (3 mini mint ice cubes of 1cm3) mouth care by palliative care nurses for a 24 hour period as requested. They will be asked to verbally rate the intensity of their dry mouth and asked to rate the distress of the symptom, both using a 10-point scale. After 24 hours standard mouth care, the intervention will be swapped over (in adjacent 24 hour window), and the participants will be asked to rate their dry mouth and the distress of the thirst symptom. 24 hours after finishing the intervention study, the participants will be asked their preferences in mouth care interventions.
Intervention code [1] 322342 0
Treatment: Other
Comparator / control treatment
Plain water ice chips
Control group
Active

Outcomes
Primary outcome [1] 329766 0
Change in the degree of thirst

During the study participants will be asked to rate their dry mouth score on a scale 0-10. This will occur pre and post mouth care, up to four to six times a day. They will also be asked which mouth care they preferred at the end of the study.
Timepoint [1] 329766 0
48 hours post commencement of the study
Primary outcome [2] 330111 0
Change in dry mouth intensity/discomfort.

During the study participants will be asked to rate their dry mouth score on a scale 0-10. This will occur pre and post mouth care, up to four to six times a day. They will also be asked which mouth care they preferred at the end of the study.
Timepoint [2] 330111 0
48 hours post commencement of the study
Secondary outcome [1] 403708 0
Patient preference for plain or mini mint ice cubes.

This will be determined by a face to face interview.
Timepoint [1] 403708 0
48 hours post commencement of the study
Secondary outcome [2] 404340 0
Staff Satisfaction with mini – mint ice cubes.

This will be determined by a staff questionnaire using an online survey tool
Timepoint [2] 404340 0
1 week post completion of the study

Eligibility
Key inclusion criteria
Age > 18 years admitted to Laurel Hospice, FMC.

Able to report thirst intensity or distress

Safe swallow and alert

AKPS > 30
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil By Mouth

Delirium using the NuDesc Score (routine collection in daily nursing assessment)

Unable to provide consent for any reason

Oral health conditions including oral sores, desquamation, open wound, fungating wound, thrush, and/or currently receiving treatment for oral disease where a specific oral care plan is required

Patient preference for no mint flavour

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21251 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 36124 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310290 0
University
Name [1] 310290 0
Flinders University
Country [1] 310290 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Allcroft
Address
Southern Adelaide Palliative Service (SAPS)

Rehabilitation, Aged and Palliative Care Building

Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia, 5042
Country
Australia
Secondary sponsor category [1] 311401 0
Individual
Name [1] 311401 0
Dr Caroline Phelan
Address [1] 311401 0
Research Centre for Palliative Care Death and Dying (RePaDD)

Rehabilitation, Aged and Palliative Care Building

Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia, 5042
Country [1] 311401 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309955 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309955 0
Flinders Medical Centre
Flinders Drive,
Bedford Park SA 5042
Ethics committee country [1] 309955 0
Australia
Date submitted for ethics approval [1] 309955 0
26/11/2021
Approval date [1] 309955 0
17/12/2021
Ethics approval number [1] 309955 0
2021/HRE00368

Summary
Brief summary
Dry mouth and the sensation of thirst are common and significant symptoms experienced by people with advanced illness. Dry mouth can be a distressing symptom, and it can interfere with talking and eating. The cause of dry mouth is often multi-factorial and includes the administration of medications which dry out oral secretions. The current management strategies for alleviating the symptom of dry mouth are limited and lack a strong evidence base, particularly in the palliative care setting.

The use of mini mint ice cubes for the relief of thirst was established as effective in significantly reducing thirst intensity and distress in critical care patients in two French intensive care units (Lemyze, Lavoisier, Temime, Granier, & Mallat, 2020). However, the mint ice cubes were not evaluated against a control group and the authors noted that further trials may be needed to confirm their findings.



This intervention was identified as appropriate for the inpatient palliative care population as the ice cubes are cost-effective and easy to produce. It is also similar to the usual care already provided at the Laurel hospice (plain ice), so is likely to be acceptable to the staff implementing the care. Therefore, there is the potential for significant clinical benefit with little cost and minimal impact to current practice patterns. Demonstrating the efficacy of this intervention for palliative care patients and comparing against a control intervention will comprise a meaningful and novel contribution to the evidence base.


Lemyze, Lavoisier, Temime, Granier, & Mallat. (2020). To relieve the patient’s thirst, refresh the mouth first: a pilot study using mini mint ice cubes in severely dehydrated patients. Journal of Pain and Symptom Management, 60(1), e82-e88
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115978 0
Dr Caroline Phelan
Address 115978 0
Research Centre for Palliative Care Death and Dying (RePaDD)

Rehabilitation, Aged and Palliative Care Building

Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia, 5042
Country 115978 0
Australia
Phone 115978 0
+61 8 82012616
Fax 115978 0
Email 115978 0
caroline.phelan@flinders.edu.au
Contact person for public queries
Name 115979 0
Dr Caroline Phelan
Address 115979 0
Research Centre for Palliative Care Death and Dying (RePaDD)

Rehabilitation, Aged and Palliative Care Building

Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia, 5042
Country 115979 0
Australia
Phone 115979 0
+61 8 82012616
Fax 115979 0
Email 115979 0
caroline.phelan@flinders.edu.au
Contact person for scientific queries
Name 115980 0
Dr Caroline Phelan
Address 115980 0
Research Centre for Palliative Care Death and Dying (RePaDD)

Rehabilitation, Aged and Palliative Care Building

Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia, 5042
Country 115980 0
Australia
Phone 115980 0
+61 8 82012616
Fax 115980 0
Email 115980 0
caroline.phelan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to make individual participant data publicly available. We will be aggregating individual observations of a variable into groups to form grouped data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Novel Approach to Managing Thirst and Dry Mouth in Palliative Care: A Prospective Randomized Cross-Over Trial.2023https://dx.doi.org/10.1016/j.jpainsymman.2023.08.005
N.B. These documents automatically identified may not have been verified by the study sponsor.