ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dry Mouth

Palliative Care

Condition category

Condition code

Oral and Gastrointestinal

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]

Treatment: Other

Comparator / control treatment

Plain water ice chips

Control group

Active

Outcomes

Primary outcome [1]

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]

48 hours post commencement of the study

Primary outcome [2]

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]

48 hours post commencement of the study

Secondary outcome [1]

Patient preference for plain or mini mint ice cubes.

This will be determined by a face to face interview.

Timepoint [1]

48 hours post commencement of the study

Secondary outcome [2]

Staff Satisfaction with mini – mint ice cubes.

This will be determined by a staff questionnaire using an online survey tool

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Rd, Bedford Park SA 5042

Country [1]

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]

Individual

Name [1]

Dr Caroline Phelan

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre 
Flinders Drive, 
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2021

Approval date [1]

17/12/2021

Ethics approval number [1]

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

Dr Caroline Phelan

Address

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

Australia

Phone

+61 8 82012616

Fax

caroline.phelan@flinders.edu.au

Contact person for public queries

Name

Caroline Phelan

Address

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

Australia

Phone

+61 8 82012616

Fax

caroline.phelan@flinders.edu.au

Contact person for scientific queries

Name

Caroline Phelan

Address

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

Australia

Phone

+61 8 82012616

Fax

caroline.phelan@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	A Novel Approach to Managing Thirst and Dry Mouth in Palliative Care: A Prospective Randomized Cross-Over Trial.	2023	https://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.

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Documents added manually

Documents added automatically