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Trial registered on ANZCTR


Registration number
ACTRN12618001270202
Ethics application status
Approved
Date submitted
6/07/2018
Date registered
27/07/2018
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial of two interventions to manage dry mouth in preoperative
elective surgical patients - A Pilot Study
Scientific title
A randomized controlled trial of two interventions to manage dry mouth in preoperative
elective surgical patients - A Pilot Study
Secondary ID [1] 295329 0
ADHB 7712
Universal Trial Number (UTN)
Trial acronym
IM DRY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry mouth 308529 0
Condition category
Condition code
Anaesthesiology 307498 307498 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saliva Substitute -Biotene Dry Mouth Oral Rinse
Preoperative patients who have offered their informed consent will be given 15 mls of Biotene to rinse their mouth.
Patients will be asked to complete a Dry mouth Score - Pre-Intervention and 30 minutes post-treatment.
Intervention code [1] 301655 0
Prevention
Intervention code [2] 301992 0
Treatment: Other
Comparator / control treatment
Water
Preoperative patients who have offered their informed consent will be given 15 mls of water to rinse their mouth.
Patients will be asked to complete a Dry mouth Score - Pre-Intervention and 30 minutes post-treatment.
The treatment can be repeated after 1 hour and subsequently hourly until the participant leaves the preoperative area for the operating room.
Control group
Active

Outcomes
Primary outcome [1] 306470 0
To Assess feasibility for a multicentered randomised control trial of two interventions for treatment of dry mouth in perioperative elective surgical patients as defined by the following:
Recruitment rate
Data completeness for pre-intervention and 30 min post intervention
Intervention acceptability
Protocol adherence- time from intervention to post-intervention assessment of 30 minutes
Timepoint [1] 306470 0
Study completion
Secondary outcome [1] 349061 0
To assess difference in mouth dryness before and after intervention; using a 100mm Visual Analogue Scale (VAS).
Absolute risk reduction in mouth dryness represented by rating of mouth dryness on a 5 point Likert scale post intervention (better or much better).
Timepoint [1] 349061 0
30 minutes after intervention

Eligibility
Key inclusion criteria
All patients undergoing elective surgery who meet all of the following criteria:
Admitted to hospital on the day of surgery
Have complied with hospital fasting guidelines
Will be under the care of the perioperative team in the pre-operative area for more than an hour.
Are able to consent to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients undergoing acute surgery.
Elective surgical patients who are admitted via the ward.
Patients who do not give consent to participate.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Feasibility outcomes will be described with simple descriptive statistics.
Primary analysis will be by intention to treat rather than per protocol.
A sample size of 100 has been chosen as this should be sufficient to test feasibility outcomes.
Scientific aims will be tested using inferential statistics.
Continuous data will be analysed using a t-test with p values and confidence interval reported, A p value <0.05 will be taken as statistically significant. Patient self-rating of dry mouth as reported by VAS will be treated as continuous data. .
Ordinal data will be collected using a tick box scale. Statistical significance measures will be calculated using Chi-squared test. A p value <0.05 will be taken as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10623 0
New Zealand
State/province [1] 10623 0
Auckland

Funding & Sponsors
Funding source category [1] 299918 0
Hospital
Name [1] 299918 0
Anaesthesia Research
Address [1] 299918 0
Perioperative Services, Level 8 Support Building. Auckland City Hospital.
Park Road, Grafton.
Auckland 1023
Country [1] 299918 0
New Zealand
Primary sponsor type
Individual
Name
Dr Douglas Campbell
Address
Perioperative Services, Level 8 Support Building. Auckland City Hospital.
Park Road, Grafton.
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 299431 0
None
Name [1] 299431 0
Address [1] 299431 0
Country [1] 299431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300787 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 300787 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300787 0
New Zealand
Date submitted for ethics approval [1] 300787 0
31/07/2017
Approval date [1] 300787 0
16/08/2017
Ethics approval number [1] 300787 0
17/NTA/152

Summary
Brief summary
Dry mouth around the time of surgery contributes towards negative patient experiences. This is a patient complaint that has not been well researched and ways to treat it have not been tested. This study will compare two potential treatments to try and reduce this unpleasant symptom for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84818 0
Dr Leesa Morton
Address 84818 0
Dept Anaesthesia
Perioperative Services, Level 8, Support Building, Auckland City Hospital. Park Road, Grafton, Auckland.1023
Country 84818 0
New Zealand
Phone 84818 0
+6493757095
Fax 84818 0
+6493754378
Email 84818 0
Leesa.morton@cdhb.health.nz
Contact person for public queries
Name 84819 0
Ms Davina McAllister
Address 84819 0
Dept Anaesthesia
Perioperative Services, Level 8, Support Building, Auckland City Hospital. Park Road, Grafton, Auckland. 1023
Country 84819 0
New Zealand
Phone 84819 0
+6493755095
Fax 84819 0
+6493754378
Email 84819 0
davinams@adhb.govt.nz
Contact person for scientific queries
Name 84820 0
Dr Leesa Morton
Address 84820 0
Dept Anaesthesia
Perioperative Services, Level 8, Support Building, Auckland City Hospital. Park Road, Grafton, Auckland. 1023
Country 84820 0
New Zealand
Phone 84820 0
+6493757095
Fax 84820 0
+6493754378
Email 84820 0
Leesa.morton@cdhb.health.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary