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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mental health

Mental wellbeing

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Mental Health

Anxiety

Mental Health

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]

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]

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]

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]

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]

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]

depression as measured by mean scores on the Patient Health Questionnaire (PHQ-9);

Timepoint [2]

Secondary outcome [3]

work productivity and activity Index-Specific Health Problem Questionnaire (WPAI:SHP);

Timepoint [3]

Secondary outcome [4]

Quality of life assessment (SF-12);

Timepoint [4]

Secondary outcome [5]

Study-specific questions on participants’ non-pharmacologic therapy preferences and experiences of participating in the trial will also be included.

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Dr Joondalup WA 6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Dr Joondalup WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Edith Cowan University’s Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Dr Joondalup WA 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/07/2021

Approval date [1]

Ethics approval number [1]

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

Dr Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for public queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for scientific queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University School of Nursing and Midwifery
270 Joondalup Dr Joondalup WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Light 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.	2022	https://dx.doi.org/10.1136/bmjopen-2021-057106

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically