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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04602286


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04602286
Ethics application status
Date submitted
19/10/2020
Date registered
26/10/2020

Titles & IDs
Public title
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)
Scientific title
An Online Randomized Controlled Trial Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Pain Experience in Adults With Recurrent and Chronic Pain
Secondary ID [1] 0 0
2019000347-S4P
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Intractable 0 0
Pain, Chronic 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Meditation (1 x 20-minute guided audio training)

Experimental: Mindfulness meditation - "focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness.

Sham comparator: Specific sham mindfulness meditation - a training session designed to specifically match the real mindfulness training while lacking the proposed active elements of mindfulness training. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness

Sham comparator: General sham mindfulness meditation - a training session designed to generally match focussed-attention mindfulness meditation while maintaining greater distance from proposed mindfulness mechanisms. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness

No intervention: Book listening control - this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"


Other interventions: Meditation (1 x 20-minute guided audio training)
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
40 minutes
Primary outcome [2] 0 0
Pain Unpleasantness
Timepoint [2] 0 0
40 minutes
Secondary outcome [1] 0 0
Pain Catastrophizing
Timepoint [1] 0 0
40 minutes

Eligibility
Key inclusion criteria
* At least 18 years of age
* Recurrent pain (two or more days in the last month)
* Chronic pain (pain most days in the last three months)
* Able to read and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not experiencing recurrent or chronic pain
* Incomplete or invalid data (response time < 32 minutes, failing attention checks)
* Completing the 20-minute training module in < 18 minutes or > 90 minutes

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2021
Sample size
Target
Accrual to date
Final
373
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Health and Behavioural Sciences - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of California, San Diego
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Melissa Day, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual trial-related participant data collected during the trial, after de-identification.

Supporting document/s available: Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Immediately following publication up and for a further 10 years .
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee. Initial contact should be directed to the contact person for scientific enquiries (Mr Jonathan Davies, [email protected]).

Note: Requestors will need to sign a data access agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://sites.google.com/view/uqcovidmeditation


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04602286

Additional trial details provided through ANZCTR
Accrual to date
36
Recruiting in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruiting in New Zealand
Province(s)/district(s)
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
University of Queensland
Primary sponsor address
The University of Queensland
Brisbane QLD 4072 Australia
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 21
University of Queensland Human Research Ethics Committee
Address [1] 21
Cumbrae-Stewart Building The University of Queensland St Lucia QLD 4072
Country [1] 21
Australia
Date submitted for ethics approval [1] 21
17/09/2020
Approval date [1] 21
30/09/2020
Ethics approval number [1] 21
2019000347
 
Public notes
TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE

https://sydneypsy.qualtrics.com/jfe/form/SV_6P8sOROQ5eq8SpL?src=ANZCTR

Contacts
Principal investigator
Title 197 0
Dr
Name 197 0
Melissa Day
Address 197 0
School of Psychology The University of Queensland Brisbane QLD 4072 Australia
Country 197 0
Australia
Phone 197 0
+61 7 3365 6230
Fax 197 0
Email 197 0
[email protected]
Contact person for public queries
Title 198 0
Mr
Name 198 0
Jonathan Davies
Address 198 0
School of Psychology The University of Queensland Brisbane QLD 4072 Australia
Country 198 0
Australia
Phone 198 0
+61 7 3365 6230
Fax 198 0
Email 198 0
[email protected]
Contact person for scientific queries
Title 199 0
Mr
Name 199 0
Jonathan Davies
Address 199 0
School of Psychology The University of Queensland Brisbane QLD 4072 Australia
Country 199 0
Australia
Phone 199 0
+61 7 3365 6230
Fax 199 0
Email 199 0
[email protected]