Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000957897p
Ethics application status
Submitted, not yet approved
Date submitted
17/07/2021
Date registered
22/07/2021
Date last updated
7/10/2021
Date data sharing statement initially provided
22/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of light acupuncture and five-element music therapy for nurses’ mental health and wellbeing during and post COVID-19
Scientific title
The experience and effects of light acupuncture and five-element music therapy for nurses’ mental health and wellbeing during and post COVID-19: a randomised crossover and feasibility study protocol
Secondary ID [1] 304817 0
Nil
Universal Trial Number (UTN)
Trial acronym

Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 322881 0
Mental wellbeing 322882 0
Condition category
Condition code
Alternative and Complementary Medicine 320458 320458 0 0
Other alternative and complementary medicine
Mental Health 320459 320459 0 0
Anxiety
Mental Health 320460 320460 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study with two weeks of intervention (3 sessions per week with six sessions in total) and a week washout period in between. Participants will receive a combination of light acupuncture and five-element music therapy from a licensed acupuncturist at the ECU Acupuncture Research Clinic. Each session will last 25-30 minutes, including preparation, treatment, and conclusion of treatment. The 3B Laser Pen (200mW) used in the intervention will have a wavelength of 808 nm in continuous wave mode to be applied to bare skin. Each pressure point will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240 J). During the treatment, the participant will be listening to the five-element music (for the duration of the light therapy) depending on their emotional types (fear, anger, joy, anxiety, and sorrow). For example, if one has anger, frustration, and rage, it could indicate they have too much Yang energy or problems with Liver or detoxification pathways. They will follow the five-element diagram to listen to the Wood element music. Study-specific questionnaires and an observational sheet will be used throughout the trial process to monitor the adherence to the intervention.
Intervention code [1] 321184 0
Treatment: Other
Comparator / control treatment
No treatment for two weeks, and participants will receive usual care (e.g., exercise).
Control group
Active

Outcomes
Primary outcome [1] 328294 0
The primary outcome for this study is the feasibility of the two-week light acupuncture and five-element music therapy for nurses working in WA hospitals. Feasibility will be assessed by measuring (1) recruitment and completion rates (No. of referred, No. of eligible, No. of enrolled, No. of withdrawals, trial recruitment rate, and trial completion rate); (2) treatment adherence (No. of completed sessions and missed sessions) and compliance; an observational sheet and study-specific questionnaires will be used throughout the trial process to monitor these outcomes; (3) a study-specific online survey will also qualitatively seek participants’ attitudes, motivation, and challenges to participation, reasons for withdrawal, missed sessions, and non-compliance with the intervention will be investigated via open-ended questions at the end of the trial.
Timepoint [1] 328294 0
Recruitment and completion rates will be assessed during the entire trial process. Treatment adherence and compliance will be assessed during the interventions. Online surveys will be administered at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).
Secondary outcome [1] 398405 0
The online questionnaires (hosted on Qualtrics) used to assess project outcomes will include therapeutic efficacy including anxiety as measured by mean scores on Generalized Anxiety Disorder 7 (GAD-7);
Timepoint [1] 398405 0
The outcome will be measured using four online surveys: at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).
Secondary outcome [2] 398488 0
depression as measured by mean scores on the Patient Health Questionnaire (PHQ-9);
Timepoint [2] 398488 0
The outcome will be measured using four online surveys: at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).
Secondary outcome [3] 398490 0
work productivity and activity Index-Specific Health Problem Questionnaire (WPAI:SHP);
Timepoint [3] 398490 0
The outcome will be measured using four online surveys: at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).
Secondary outcome [4] 398493 0
Quality of life assessment (SF-12);
Timepoint [4] 398493 0
The outcome will be measured using four online surveys: at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).
Secondary outcome [5] 398495 0
Study-specific questions on participants’ non-pharmacologic therapy preferences and experiences of participating in the trial will also be included.
Timepoint [5] 398495 0
The outcome will be measured at baseline (T0).

Eligibility
Key inclusion criteria
Participants are eligible for this study if they are registered nurses or enrolled nurses and working at least three shifts per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who have a fever or are highly sensitive to light, diagnosed with cancer, or pregnant women will not be eligible.

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)
Sequence numbers of each participant will be generated by a computer produced random list, performed by an independent, blinded statistical expert.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Our statistical expert will generate the allocation sequence via a simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
For the primary outcome, rates of recruitment (no. consented/eligible), completion (undertaken baseline and follow-up tests), adherence (participants completed sessions/no. of sessions), and adverse events (number and number per participant hour) will be calculated. The secondary outcome will be assessed following intention-to-treat principles. Linear mixed modelling will be conducted to assess changes in secondary outcomes throughout the study. This model allows for the inclusion of missing data in an intention-to-treat analysis without imputations (e.g. last-observation-carried-forward). If necessary, the analysis will be adjusted for potential confounding factors such as age, gender, education levels. Normality assumptions will be assessed using the Shapiro-Wilk test. Statistical significance will be set at an alpha level of 0.05. Corrections will be applied to all analysed outcomes to account for multiple comparisons. Appropriate effects sizes will be reported and interpreted.
The qualitative data collected via open-ended questions across the four online surveys will be used to help explain or elaborate on the quantitative data. Qualitative data will be analysed using template thematic analysis. Template thematic analysis uses ‘a priori’ code frames to analyse and report on the data. The initial skeleton code frame is often formulated from the questions asked of participants and then built upon during analysis in an iterative process.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 309188 0
University
Name [1] 309188 0
Edith Cowan University
Country [1] 309188 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 310149 0
None
Name [1] 310149 0
Address [1] 310149 0
Country [1] 310149 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309044 0
Edith Cowan University’s Human Research Ethics Committee
Ethics committee address [1] 309044 0
270 Joondalup Dr Joondalup WA 6027
Ethics committee country [1] 309044 0
Australia
Date submitted for ethics approval [1] 309044 0
16/07/2021
Approval date [1] 309044 0
Ethics approval number [1] 309044 0

Summary
Brief summary
Australian nurses have experienced higher levels of anxiety during the COVID-19 pandemic compared with the pre-pandemic. This may have affected their long-term mental health and intention to stay in the profession resulting in a workforce shortage and its associated impact on the health of the public. This protocol details a trial to examine the feasibility of light acupuncture and five-element music therapy intervention to involve nurses’ mental wellbeing in Western Australian (WA) hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112766 0
Dr Carol Chunfeng Wang
Address 112766 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 112766 0
Australia
Phone 112766 0
+61 8 63043589
Fax 112766 0
Email 112766 0
[email protected]
Contact person for public queries
Name 112767 0
Dr Carol Chunfeng Wang
Address 112767 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 112767 0
Australia
Phone 112767 0
+61 8 63043589
Fax 112767 0
Email 112767 0
[email protected]
Contact person for scientific queries
Name 112768 0
Dr Carol Chunfeng Wang
Address 112768 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027
Country 112768 0
Australia
Phone 112768 0
+61 8 63043589
Fax 112768 0
Email 112768 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


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
SourceTitleYear of PublicationDOI
EmbaseLight acupuncture and five-element music therapy for nurses' mental health and well-being during and post-COVID-19: Protocol for a randomised cross-over feasibility study.2022https://dx.doi.org/10.1136/bmjopen-2021-057106
N.B. These documents automatically identified may not have been verified by the study sponsor.