Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000544178
Ethics application status
Approved
Date submitted
23/03/2019
Date registered
5/04/2019
Date last updated
29/07/2021
Date data sharing statement initially provided
5/04/2019
Date results information initially provided
29/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of 5-Minute Mindfulness on Peace in Alleviating Suffering and Improving Spiritual Well-Being among Palliative Care Patients: A Randomized Controlled Trial
Scientific title
Effectiveness of 5-Minute Mindfulness on Peace in Alleviating Suffering and Improving Spiritual Well-Being among Palliative Care Patients: A Randomized Controlled Trial
Secondary ID [1] 297732 0
Nil Known
Universal Trial Number (UTN)
U1111-1230-2440
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 312060 0
Neurodegenerative diseases 312190 0
End stage renal failure 312191 0
Condition category
Condition code
Cancer 310623 310623 0 0
Any cancer
Neurological 310624 310624 0 0
Neurodegenerative diseases
Renal and Urogenital 310740 310740 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will be guided through a single 5-minute mindfulness on peace session. The 5-minute session involves focusing attention on the breath and then on the feeling of peace as it arise. This 5-minute session is administered by the principle investigator who a certified mindfulness trainer. The investigator remains by the side of the patient through out the 5 minute session, hence directly supervises adherence to the intervention.
Intervention code [1] 313970 0
Treatment: Other
Comparator / control treatment
Patients in the control group will have a conversation with the researcher based on a pre-determined set of questions for 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 319471 0
Total suffering score on a scale of 0 - 10 as scored on the suffering pictogram
Timepoint [1] 319471 0
After the 5 minute intervention session
Primary outcome [2] 319472 0
Total score on the FACIT-Sp12 questionnaire
Timepoint [2] 319472 0
After the 5 minute intervention session
Secondary outcome [1] 368314 0
Mean composite score of discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance, emptiness on the suffering pictogram
Timepoint [1] 368314 0
After the 5 minute intervention session
Secondary outcome [2] 369022 0
Mean score of discomfort on the suffering pictogram
Timepoint [2] 369022 0
After the 5 minute intervention
Secondary outcome [3] 369023 0
Mean score of worry on the suffering pictogram
Timepoint [3] 369023 0
After the 5 minute intervention session
Secondary outcome [4] 369024 0
Mean score of anger on the suffering pictogram
Timepoint [4] 369024 0
After the 5 minute intervention session
Secondary outcome [5] 369025 0
Mean score of sadness on the suffering pictogram
Timepoint [5] 369025 0
After the 5 minute intervention session
Secondary outcome [6] 369026 0
Mean score of hopelessness on the suffering pictogram
Timepoint [6] 369026 0
After the 5 minute intervention session
Secondary outcome [7] 369027 0
Mean score of difficulty in acceptance on the suffering pictogram
Timepoint [7] 369027 0
After the 5 minute intervention session
Secondary outcome [8] 369028 0
Mean score of emptiness on the suffering pictogram
Timepoint [8] 369028 0
After the 5 minute intervention session

Eligibility
Key inclusion criteria
Adult palliative care patients aged 18 years and above
At least moderate suffering as indicated by global suffering score of > 3 on suffering pictogram
Able to follow and understand simple instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Reduced consciousness based on Glasgow Coma Scale (GCS)
Delirious and confused patients based on Confusion Assessment Method (CAM)
Patients who are less communicative
Patients who are unable to sustain attention for 10 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)
Randomization will be kept in a sealed enveloped to be opened after a patient has consented to participate in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence generated by block randomization in groups of 4 using computer-generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2019
Date of last participant enrolment
Anticipated
30/09/2019
Actual
1/06/2019
Date of last data collection
Anticipated
30/09/2019
Actual
1/06/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21349 0
Malaysia
State/province [1] 21349 0
Selangor

Funding & Sponsors
Funding source category [1] 302259 0
University
Name [1] 302259 0
University Malaya Medical Centre
Country [1] 302259 0
Malaysia
Primary sponsor type
University
Name
University Malaya Medical Centre
Address
University Malaya Medical Centre, Jalan Universiti, Lembah Pantai, 50603 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 302121 0
None
Name [1] 302121 0
Address [1] 302121 0
Country [1] 302121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302935 0
Medical Research Ethics Committee, University Malaya Medical Centre
Ethics committee address [1] 302935 0
Lembah Pantai, 59100 Kuala Lumpur, Malaysia
Ethics committee country [1] 302935 0
Malaysia
Date submitted for ethics approval [1] 302935 0
29/01/2019
Approval date [1] 302935 0
27/02/2019
Ethics approval number [1] 302935 0
2019117-7012

Summary
Brief summary
We intend to test if a single 5 minute session of Mindfulness of Peace has an effect on suffering and spiritual well being. In the 5 minute Mindfulness of Peace session, patients will be guided to focus on their breath. Then, as the feeling of peace arise, to focus on the feeling of peace. We will compare the effects of Mindfulness of Peace with a 5 minute conversation with the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91898 0
A/Prof Tan Seng Beng
Address 91898 0
University Malaya Medical Centre,
Jalan Universiti, Lembah Pantai, 50603 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 91898 0
Malaysia
Phone 91898 0
+60 03 7949 4422
Fax 91898 0
+60 03 7956 2253
Email 91898 0
[email protected]
Contact person for public queries
Name 91899 0
Dr Lim Liang Yik
Address 91899 0
University Malaya Medical Centre,
Jalan Universiti, Lembah Pantai, 50603 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 91899 0
Malaysia
Phone 91899 0
+60 03 7949 4422
Fax 91899 0
Email 91899 0
[email protected]
Contact person for scientific queries
Name 91900 0
Dr Lim Liang Yik
Address 91900 0
University Malaya Medical Centre,
Jalan Universiti, Lembah Pantai, 50603 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 91900 0
Malaysia
Phone 91900 0
+60 03 7949 4422
Fax 91900 0
Email 91900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication and for 2 years after
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes American Journal of Hospice and Palliative Medicin... [More Details]

Documents added automatically
No additional documents have been identified.