Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000670774
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
20/06/2013
Date last updated
20/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of mindfulness meditation to reduce anger and violence in Thai youth, quasi-experimental design
Scientific title
A study on the effectiveness of mindfulness meditation to reduce anger and violence in Technical College students in Thailand.
Secondary ID [1] 282651 0
'Nil Known'
Universal Trial Number (UTN)
U1111-1144-2240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anger in Thai youths 289353 0
Condition category
Condition code
Alternative and Complementary Medicine 289688 289688 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mindfulness meditation intervention emphasises concentration,is implemented from 9.00 am to 5.00 pm (7 hours) a day for 3 consecutive weeks.
Concentration training began with a sitting meditation and follow by a walking meditation.

According to sitting mediation, participants sat quietly with eyes closed and placed their attention on breathing either at the tip of the nose or from the diaphragm. The sitting meditation was operated approximately 3 hours (9.00-12.00) in the morning.

Next, a walking meditation was used as an alternative to sitting. In walking meditation, participants simply stood, then began to walk at a fairly slow but normal walking pace and in a normal manner. The walking meditation was carried out in the afternoon from 1.30 pm to 5 pm.
Intervention code [1] 287317 0
Behaviour
Comparator / control treatment
Mindfulness Meditation is applied for intervention group for 3 weeks. As control group, there is no any activity being applied as "no treatment". Control participants attend a normal class in the college.
Control group
Active

Outcomes
Primary outcome [1] 289780 0
Anger emotions determine as high anger when are above 75th percentile, and normal emotion when are lower than 75th percentile.

The State–Trait Anger Expression Inventory (STAXI-2) scale is a 32-item questionnaire developed to measure characteristic styles of anger emotions.
Timepoint [1] 289780 0
Pre-test is assessed one week prior to intervention. Post-test is conducted 1 and 3 months follow-up.
Primary outcome [2] 289781 0
Violence behaviours measure harmful activities within 30 days.

The measure of violent behavior used in this study was based on the Pittsburgh Youth Study’s measure of serious violence. The self-reported measure consists of five items: aggravated assault; two robbery items; rape; and gang fights.
Timepoint [2] 289781 0
Pre-test measurement is implemented 1 week before, and 1 and 3 months post-test after finishing intervention.
Secondary outcome [1] 303229 0
'Nil'
Timepoint [1] 303229 0
'Nil'

Eligibility
Key inclusion criteria
Full-time students in all year levels within every department in a technical college.
Minimum age
16 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria is absent interventions at least 3 days. Also, they have lost contact, dropped out and expelled from the college in post-intervention period (1-3 month).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All full-time students in the college are invited to the study,and the allcocation for either intervention or control group based on a classroom timetable.
If they have a rigid timetable- they will allocate to control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Quasi-randomisation method is used in the study. The allocation is based on willingness and the classroom timetable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size in the study was determined by using type I error, type II error, and standard deviations and the number of sample sizes were 36 for both groups. Nevertheless, forty participants were recruited for the mindfulness meditation group and fifty-six for the control group in order to achieve the study design.

Two-way repeated measures analysis of variance (ANOVA) was used to compare scores on the dependent measures at pre- and post-test (1-month and 3-month follow-up). Independent t-tests were used to calculate intervention effects between pre-treatment and post-treatment for all measurement scales for both the intervention and control groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2011
Actual
8/04/2011
Date of last participant enrolment
Anticipated
22/04/2011
Actual
22/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 5139 0
Thailand
State/province [1] 5139 0
Bangkok

Funding & Sponsors
Funding source category [1] 287429 0
University
Name [1] 287429 0
Flinders University
Country [1] 287429 0
Australia
Primary sponsor type
University
Name
Dr. Nualnong Wongtongkam
Address
School of Biomedical Science, Charles Sturt University, Bathurst, NSW, 2795 Australia
Country
Australia
Secondary sponsor category [1] 286176 0
None
Name [1] 286176 0
Address [1] 286176 0
Country [1] 286176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289409 0
Social and Behavioural Research Ethics Committee
Ethics committee address [1] 289409 0
Flinders University, Adelaide, South Australia
Ethics committee country [1] 289409 0
Australia
Date submitted for ethics approval [1] 289409 0
11/08/2011
Approval date [1] 289409 0
02/12/2011
Ethics approval number [1] 289409 0
5027

Summary
Brief summary
The effectiveness of Mindfulness Meditation is evaluated in response to reduce anger expression and violent behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40658 0
Dr Nualnong Wongtongkam
Address 40658 0
School of Biomedical Sciences, Charles Sturt University, Panorama Ave, Bathurst, NSW, 2795.
Country 40658 0
Australia
Phone 40658 0
+61 02 63384309
Fax 40658 0
Email 40658 0
[email protected]
Contact person for public queries
Name 40659 0
Dr Nualnong Wongtongkam
Address 40659 0
School of Biomedical Sciences, Charles Sturt University, Panorama Ave, Bathurst, NSW, 2795.
Country 40659 0
Australia
Phone 40659 0
+61 02 63384309
Fax 40659 0
Email 40659 0
[email protected]
Contact person for scientific queries
Name 40660 0
Dr Nualnong Wongtongkam
Address 40660 0
School of Biomedical Sciences, Charles Sturt University, Panorama Ave, Bathurst, NSW, 2795.
Country 40660 0
Australia
Phone 40660 0
+61 02 63384309
Fax 40660 0
Email 40660 0
[email protected]

No information has been provided regarding IPD availability


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.