Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000598886
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
19/05/2021
Date last updated
19/05/2021
Date data sharing statement initially provided
19/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Students, Acupuncture and Stress – A feasibility study investigating the impact of acupuncture on stress in tertiary education students
Scientific title
Students, Acupuncture and Stress – A feasibility study investigating the impact of high and low frequency acupuncture dosage in overall perceived stress changes in tertiary education students
Secondary ID [1] 303643 0
None
Universal Trial Number (UTN)
Trial acronym
SAS (Students, Acupuncture and Stress)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 321031 0
Psychological Stress 321032 0
Condition category
Condition code
Mental Health 318834 318834 0 0
Other mental health disorders
Alternative and Complementary Medicine 318835 318835 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture:
Two arms (High and Low Frequency)

Intervention 1 – High Frequency

The patient will be asked to lie supine (face up) on a treatment table. There are four acupuncture points being needled bilaterally, involving a total of 8 needles. The points and order of insertion are: Liver 3, Large Intestine 4, Spleen 6 and Pericardium 6. The needle will be manipulated using a lifting thrusting and rotation method immediately after insertion for a minimum of 10 seconds to illicit a sensation of de qi (numbness, heaviness, dull ache) is reported. The needles will be retained for 20 minutes. The intervention will be performed twice a week for two weeks totalling four treatments.
Needles will be removed in the same order as insertion and immediately placed in a Sharps container.

Intervention 2 – Low Frequency
As for high frequency but: The intervention will be performed once per week for four weeks for a total of four interventions.

The location, needling angle and needling depth will be as follows:

Large Intestine 4
Location: On the dorsum of the hand in the middle of the 2nd metacarpal on the lateral side. At the highest point of the muscle when the thumb and index finger are held close together.

Needling Angle: Perpendicular
Needling Depth: 5mm
Needle Type: Balance, 0.20 x 30mm

Liver 3
Location: On the dorsum of the foot in the angle formed by the 1st and 2nd metatarsals, just anterior to the articulation with the 1st and 2nd cuneiforms.

Needling Angle: Perpendicular
Needling Depth: 3mm
Needle Type: Balance, 0.20 x 30mm

Pericardium 6
Location: Two anatomical units above the wrist flexure between the tendons of the palmaris longus and the flexor carpi radialis.

Needling Angle: Perpendicular
Needling Depth: 3mm
Needle Type: Balance, 0.18 x 15mm

Spleen 6
Location: On the anterior/medial aspect of the leg, 3 anatomical units above the ‘tip’ (medial extremity) of the medial malleolus, just posterior to the border of the tibia.

Needling Angle: Perpendicular
Needling Depth: 4 mm
Needle Type: Balance, 0.20 x 30mm

All interventions will be performed by individual/s with a Bachelor’s degree in Traditional Chinese Medicine/Acupuncture, have 10 years clinical experience, and registered health care practitioners with the Chinese Medicine Board of Australia (Ahpra:CMBA).

All interventions will be performed at the University of Technology, Sydney (UTS) Chinese Medicine Clinic, located at Building 4, University of Technology Sydney, Broadway NSW 2007, Australia

Adherence to the intervention will be monitored using an online diary and booking system (via MS Outlook). Participants who have missed an intervention will be emailed for further information regarding future interventions. Missed data points will be filled using the Last Observation Carried Forward (LOCF) method.
Intervention code [1] 319938 0
Treatment: Other
Comparator / control treatment
Intervention 2 (Comparator) – Low Frequency
The intervention will be performed once per week for four weeks for a total of four interventions.
The patient will be asked to lie supine (face up) on a treatment table. There are four acupuncture points being needled bilaterally, involving a total of 8 needles. The points and order of insertion are: Liver 3, Large Intestine 4, Spleen 6 and Pericardium 6. The needle will be manipulated using a lifting thrusting and rotation method immediately after insertion for a minimum of 10 seconds to illicit a sensation of de qi (numbness, heaviness, dull ache) is reported. The needles will be retained for 20 minutes.
Needles will be removed in the same order as insertion and immediately placed in a Sharps container.
As the acupuncture points are located on distal portions of the arms and legs, no disrobing of the participants is anticipated other than removal of footwear.

Description of Acupuncture Point Locations
The location, needling angle and needling depth will be as follows (Rogers & Rogers 1995):
Large Intestine 4

Location: On the dorsum of the hand in the middle of the 2nd metacarpal on the lateral side. At the highest point of the muscle when the thumb and index finger are held close together.

Needling Angle: Perpendicular
Needling Depth: 5mm
Needle Type: Balance, 0.20 x 30mm

Liver 3
Location: On the dorsum of the foot in the angle formed by the 1st and 2nd metatarsals, just anterior to the articulation with the 1st and 2nd cuneiforms.

Needling Angle: Perpendicular
Needling Depth: 3mm
Needle Type: Balance, 0.20 x 30mm

Pericardium 6
Location: Two anatomical units above the wrist flexure between the tendons of the palmaris longus and the flexor carpi radialis.

Needling Angle: Perpendicular
Needling Depth: 3mm
Needle Type: Balance, 0.18 x 15mm

Spleen 6
Location: On the anterior/medial aspect of the leg, 3 anatomical units above the ‘tip’ (medial extremity) of the medial malleolus, just posterior to the border of the tibia.

Needling Angle: Perpendicular
Needling Depth: 4 mm
Needle Type: Balance, 0.20 x 30mm
Control group
Active

Outcomes
Primary outcome [1] 326786 0
The primary outcome is a patient reported outcome measure – the Perceived Stress Scale (PSS14). The PSS14 is a self-reported measure which assesses the degree to which the respondent perceives stress specific to their life situation within the last month. There are 14 items, rated using a 5-point Likert scale ranging from ‘Never’ (0) to ‘Very Often’ (4). Scoring is a mixed of actual and reverse scoring each item to obtain a score in the range of 0-56.
The mean difference in PSS-14 scores will be compared between pre and post intervention for differences within each acupuncture dosage treatment-frequency group and also between the two groups.
Timepoint [1] 326786 0
PSS-14 Timepoints:
Baseline:
Weekly for four weeks prior to intervention commencement

High Frequency Arm:
Twice per week for two weeks immediately after interventions; then post-treatment at 14 days and 28 days after the final intervention. The primary timepoint will be 14 days after the final intervention.

Low Frequency Arm:
Once per week immediately after interventions; then post-treatment at 14 days and 28 days after the final intervention. The primary timepoint will be 14 days after the final intervention.
Secondary outcome [1] 392676 0
Changes in different causes/types of stress as measured by 10-point scales in the Additional Stress Questionnaire (ASQ) will be analysed. The ASQ is comprised of five questions about types and overall stress levels with 10-point Likert Scale responses.
Timepoint [1] 392676 0
Baseline:
Weekly for four weeks prior to intervention commencement.

High Frequency Arm:
Twice per week for two weeks immediately after interventions; then post-treatment at 14 days and 28 days after the final intervention.

Low Frequency Arm:
Once per week immediately after interventions; then post-treatment at 14 days and 28 days after the final intervention.
Secondary outcome [2] 392677 0
The Participant Final Questionnaire (PFQ) was designed specifically for this study. It comprises 4 questions with 10 point Likert Scale responses, and one open question for feedback on study feasibility. The questions pertain to stress involved with attending interventions and preferences for higher or lower intervention frequency.
Timepoint [2] 392677 0
28 days after the final intervention.
Secondary outcome [3] 392678 0
The Credibility and Expectancy Questionnaire (CEQ) is used to measure treatment expectancy and rationale credibility to allow for possible differences in participants’ perception of the intervention and how that may impact observed outcomes. The QEC consists of four questions using a Likert Scale response from zero to six.
Timepoint [3] 392678 0
Two questions previous to beginning interventions; and two questions upon completion of the trial.

Eligibility
Key inclusion criteria
• Currently enrolled as a tertiary student at UTS
• Aged 18 and over
• Able to provide informed consent
• Self-identify as ‘stressed’
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Bleeding disorders or any disorder that prohibits the use of acupuncture or certain points specified in this intervention;
• Use of prescribed anti-coagulant medication (such as warfarin) that may interfere with blood clotting
• Use of acupuncture for stress in the 14 days prior to the intervention
• Pregnancy
• Needle phobia
• Unwilling to complete outcome measures or attend the clinic for treatment
• Suicidal ideation

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)
Randomisation will be carried out by a third party using randomisation software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Several statistical tests will be used.
Baseline characterises of participants will be investigated using both t-test and chi square test.
If data meet normality assumptions the following statistical tests will be used for different objectives.
• Repeated measure ANOVA: to investigate mean changes of stress across different intervention measurement time points in each study group.
• Paired t-test: to compare baseline measurement with the final measurement in each study group.
• Independent t-test: to compare mean differences at each measurement time across the inventions (HF/ LF)
• Pearson correlation : to investigate if there is any relationship between intensity of the perceived stress and other variables such as gender OR study-year…
• Spearman correlation: to investigate robustness of the two scale, PSS-14 & ASQ, used to measure stress.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308062 0
University
Name [1] 308062 0
University of Technology, Sydney
Country [1] 308062 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
University of Technology Sydney, PO Box 123, Broadway NSW 2007, Australia
Country
Australia
Secondary sponsor category [1] 308792 0
None
Name [1] 308792 0
Address [1] 308792 0
Country [1] 308792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308054 0
UTS Human Research Ethics Committee
Ethics committee address [1] 308054 0
Ethics committee country [1] 308054 0
Australia
Date submitted for ethics approval [1] 308054 0
Approval date [1] 308054 0
19/01/2021
Ethics approval number [1] 308054 0
ETH20-5098

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

Contacts
Principal investigator
Name 109362 0
Mr Dane Couter
Address 109362 0
University of Technology, Sydney
15 Broadway
Ultimo
NSW 2007
Country 109362 0
Australia
Phone 109362 0
+61 414645118
Fax 109362 0
Email 109362 0
[email protected]
Contact person for public queries
Name 109363 0
Dane Couter
Address 109363 0
University of Technology, Sydney
15 Broadway
Ultimo
NSW 2007
Country 109363 0
Australia
Phone 109363 0
+61 414645118
Fax 109363 0
Email 109363 0
[email protected]
Contact person for scientific queries
Name 109364 0
Dane Couter
Address 109364 0
University of Technology, Sydney
15 Broadway
Ultimo
NSW 2007
Country 109364 0
Australia
Phone 109364 0
+61 414645118
Fax 109364 0
Email 109364 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
Data will not be shared, in accordance with the confidentiality agreement signed by participants


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10946Study protocol  [email protected] Dane Couter SPIRIT Protocol
10947Ethical approval  [email protected] HREC APPROVAL NUMBER ETH20-5098



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.