Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000735853
Ethics application status
Approved
Date submitted
18/04/2021
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
How does balneotherapy impact sleep and mood?
Scientific title
A randomised controlled trial to investigate sleep, mood state and cardiovascular effects of four spa behaviours in healthy participants aged 18 to 45 years
Secondary ID [1] 300790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 316654 0
Sleep quality 316655 0
Condition category
Condition code
Alternative and Complementary Medicine 314902 314902 0 0
Other alternative and complementary medicine
Mental Health 319670 319670 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be randomised to weekly placements over 4 weeks in the following interventions which deliver an assortment of manipulated independent variables:
- Thermoneutral bathing (37 degrees C) for 20 minutes, seated position, neck high.
- Warm water bathing (39 degrees C) for 20 minutes, seated position, neck high.
- Hot water bathing (42 degrees C) 2X10 minutes sessions, seated position, neck high, with X2 cold plunges.
- Quiet time X20 minutes in semi-darkened dome lounges within Peninsula Hot Springs (PHS) surrounds, no bathing.
All interventions take place within Peninsula Hot Springs, Victoria, Australia. Each intervention takes place at 7.30pm. Bathing interventions are in outdoor geothermal mineral pools. Research assistants onsite control for adherence to the intervention protocols, including session timing, water temperatures and distribution/collection of self-reported questionnaires.
Washout between treatments is 7 days.
Intervention code [1] 317114 0
Treatment: Other
Comparator / control treatment
This is the fourth intervention group described above: Quiet time X20 minutes in semi-darkened dome lounges within PHS surrounds, no bathing.
Control group
Active

Outcomes
Primary outcome [1] 323220 0
Polysomnograph data
Timepoint [1] 323220 0
Sleep data uploaded morning after each intervention
Primary outcome [2] 323221 0
Actigraph wrist watch
Timepoint [2] 323221 0
Sleep data uploaded morning after each intervention
Primary outcome [3] 323222 0
Subjective mood reports: Profile of Mood State (PoMS) 2SF
Timepoint [3] 323222 0
Pre and post 4 week program.
Pre and post each intervention.
Secondary outcome [1] 381211 0
Karolinsky Sleep Scale (KSS) reporting
Timepoint [1] 381211 0
Pre and post each intervention.
Secondary outcome [2] 381212 0
Blood pressure and heart rate measured as composite outcomes by oscillometric automatic blood pressure monitors.
Timepoint [2] 381212 0
Pre and post each intervention
Secondary outcome [3] 381213 0
Short Form 8 Quality of Life index
Timepoint [3] 381213 0
Pre and post 4 week program

Eligibility
Key inclusion criteria
Healthy volunteers aged 18-45, local to the testing site (living within 20 minutes drive).
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unable to give informed consent
• A known mood state disorder (eg. anxiety/depression) and/or psychopharmacological medication, hypertensive medication within 4 weeks of recruitment.
• Sleeping problems/taking any sleep medications or supplements that may interfere with sleep.
• Caffeine or other addictions.
• Serious illness including: Rheumatic disease, cardiovascular disease, diabetes mellitus.
• Abnormal blood pressure.
• Have undergone cancer treatment within 4 weeks of recruitment.
• Bathing within 2 weeks prior to the study.
• Shift workers: defined as those who work outside of generally perceived normal working hours.
• Holiday makers will be excluded for the likelihood their escape/getaway motivation skews sleep/relaxation/QoL data and they are considered more likely to drop-out.
• Allergic reaction to the PHS water.
• Claustrophobia.
• Pregnant or within lactation period.
• Epilepsy.
• Recent hospitalisation, surgery or antibiotic therapy.
• Need to travel across time zones two weeks before or during the study period.
• No evening baths at home post-intervention.
• Rheumatic diseases including arthritis, causing pain at night.
• Cortisone intake within 4 weeks prior to the study.
• Changes in dose rates of other medications up to 1 week before study entry.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
28/04/2021
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
28/05/2021
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305247 0
University
Name [1] 305247 0
RMIT University
Country [1] 305247 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 305605 0
None
Name [1] 305605 0
Address [1] 305605 0
Country [1] 305605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305590 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 305590 0
Ethics committee country [1] 305590 0
Australia
Date submitted for ethics approval [1] 305590 0
20/03/2020
Approval date [1] 305590 0
31/03/2021
Ethics approval number [1] 305590 0
22950

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

Contacts
Principal investigator
Name 100882 0
Mr James Clark-Kennedy
Address 100882 0
RMIT, Plenty Road, Bundoora, VIC 3083
Country 100882 0
Australia
Phone 100882 0
+61 408561347
Fax 100882 0
Email 100882 0
[email protected]
Contact person for public queries
Name 100883 0
Russell Conduit
Address 100883 0
RMIT, Plenty Road, Bundoora, VIC 3083
Country 100883 0
Australia
Phone 100883 0
+61 3 9925 6658
Fax 100883 0
Email 100883 0
[email protected]
Contact person for scientific queries
Name 100884 0
Russell Conduit
Address 100884 0
RMIT, Plenty Road, Bundoora, VIC 3083
Country 100884 0
Australia
Phone 100884 0
+61 3 9925 6658
Fax 100884 0
Email 100884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy considerations for participants
RMIT data ownership


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
No additional documents have been identified.