Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000346178
Ethics application status
Approved
Date submitted
3/03/2019
Date registered
5/03/2019
Date last updated
9/07/2021
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving mood and sleep in teenage males using relaxation music played on crystal singing bowls
Scientific title
A pilot study evaluating the effects of relaxation music from quartz crystal singing bowls on mood and sleep in teenage males
Secondary ID [1] 297597 0
None
Universal Trial Number (UTN)
U1111-1224-1895
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 311856 0
Anxiety 311867 0
Depression 311868 0
Condition category
Condition code
Alternative and Complementary Medicine 310450 310450 0 0
Other alternative and complementary medicine
Mental Health 310459 310459 0 0
Anxiety
Mental Health 310460 310460 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a single session with a group of 20 participants listening with eyes closed for 25 minutes to relaxation music played live by a musician on quartz crystal singing bowls.
Intervention code [1] 313829 0
Other interventions
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319317 0
The difference between pretest and posttest scores after the intervention in all six Profile of Mood States-Adolescents (POMS-A) questionnaire mood sub-scale scores
Timepoint [1] 319317 0
Approx. 10-30 minutes after the intervention
Secondary outcome [1] 367723 0
Within-subject changes after intervention in the POMS-A subscale score for tension
Timepoint [1] 367723 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [2] 367781 0
Within-subject changes after intervention in the POMS-A subscale score for anger
Timepoint [2] 367781 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [3] 367782 0
Within-subject changes after intervention in the POMS-A subscale score for fatigue
Timepoint [3] 367782 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [4] 367783 0
Within-subject changes after intervention in the POMS-A subscale score for depression
Timepoint [4] 367783 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [5] 367784 0
Within-subject changes after intervention in the POMS-A subscale score for vigour
Timepoint [5] 367784 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [6] 367785 0
Within-subject changes after intervention in the POMS-A subscale score for confusion
Timepoint [6] 367785 0
Approx. 30 minutes after the intervention and again one week and three weeks after the intervention
Secondary outcome [7] 367786 0
Within-subject changes after intervention in current sleep items in the Auckland Sleep Questionnaire
Timepoint [7] 367786 0
One week and three weeks after the intervention

Eligibility
Key inclusion criteria
• Adequate hearing
• Fluent in English
• Written, informed consent
• Currently attending high school
Minimum age
16 Years
Maximum age
17 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Taking any prescription medication except for asthma
• Regular users of relaxation music from quartz crystal singing bowls

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment. All participants receive the study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-test - posttest design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
The primary endpoint is the mean within-subject difference between baseline and post-intervention in the POMS-A sub-scale scores for tension, anger, fatigue, depression, vigour and confusion. Multivariate analysis of variance for repeated measures (MANOVA-RM) will be used to examine pre-test–posttest changes in all six POMS-A subscales simultaneously, to control for experimental-wise error. A convenience sample of 20 subjects gives 90% power (2-alpha=0.05) to detect a 25% mean reduction (SD<36) across all POMS-A subscales simultaneously.

Analysis plan:
The primary endpoint will be analysed by MANOVA-RM, to examine pre-test–posttest changes in all six POMS-A subscales simultaneously. In this analysis the POMS-A subscale scores are the dependent variables and intervention is the independent variable.
Univariate analysis of variance (ANOVA) will be used to evaluate the significance of within-subject differences in the POMS-A subscale scores and cs-ASQ scores, and the persistence of score changes one and three weeks after the intervention. Effect size estimates will be calculated using standardised mean pretest–posttest differences to examine the clinical significance of observed changes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2019
Actual
8/06/2020
Date of last participant enrolment
Anticipated
8/06/2019
Actual
8/06/2020
Date of last data collection
Anticipated
30/06/2019
Actual
30/06/2020
Sample size
Target
20
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 21325 0
New Zealand
State/province [1] 21325 0
Waikato

Funding & Sponsors
Funding source category [1] 302144 0
Hospital
Name [1] 302144 0
Waikato District Health Board
Country [1] 302144 0
New Zealand
Primary sponsor type
Individual
Name
Assoc. Prof. Michael Jameson
Address
Peter Rothwell Academic Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 301980 0
None
Name [1] 301980 0
N/A
Address [1] 301980 0
N/A
Country [1] 301980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302823 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 302823 0
Ethics committee country [1] 302823 0
New Zealand
Date submitted for ethics approval [1] 302823 0
06/03/2019
Approval date [1] 302823 0
04/04/2019
Ethics approval number [1] 302823 0
19/NTB/48

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

Contacts
Principal investigator
Name 91518 0
Mr Alexander Matthews
Address 91518 0
C/o A/Prof. Michael Jameson
Peter Rothwell Academic Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 91518 0
New Zealand
Phone 91518 0
+64 7 839 8899
Fax 91518 0
Email 91518 0
[email protected]
Contact person for public queries
Name 91519 0
Michael Jameson
Address 91519 0
Oncology Department
Waikato District Health Board
Pembroke St
Private Bag 3200
Hamilton 3240
Country 91519 0
New Zealand
Phone 91519 0
+64 7 839 8899
Fax 91519 0
+64 7 839 8778
Email 91519 0
[email protected]
Contact person for scientific queries
Name 91520 0
Michael Jameson
Address 91520 0
Oncology Department
Waikato District Health Board
Pembroke St
Private Bag 3200
Hamilton 3240
Country 91520 0
New Zealand
Phone 91520 0
+64 7 839 8899
Fax 91520 0
+64 7 839 8778
Email 91520 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
Pilot study only. Analysis of whole group data will be published.


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.