Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000149369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/10/2025
Date registered
Help: Date registered
6/02/2026
Date last updated
Help: Date last updated
6/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/02/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of different auriculotherapy stimulation modalities in neuropsychiatric disorders: integrated DASS-21 and HRV assessment
Scientific title
Effectiveness of different auriculotherapy stimulation modalities in neuropsychiatric disorders: integrated DASS-21 and heart rate variability assessment in a multicenter controlled trial
Additional trial identifiers [1] 315681 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 339369 0
Anxiety 339370 0
Psychological distress 339372 0
Condition category
Condition code
Mental Health 335620 335620 0 0
Depression
Mental Health 335621 335621 0 0
Anxiety
Mental Health 335622 335622 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Allocation: Quasi-experimental design with allocation based on the geographical location of the participating center.

Arm 1: Laser Auriculotherapy (Group B) Location: Vicenza Center. Materials: Sedatelec Premio 32 EVO laser device. Specifications: 905 nm infrared radiation, peak power 100 W, super-pulsed mode (pulse duration 100 ns), delivering constant energy of 5 J/min. Procedure: Transcutaneous stimulation of left auricular points (Chinese Kidney SC6-CW8, Chinese Heart IC4, SanJiao IC1). Stimulation lasts 1 minute per point (3 minutes total). Schedule: 5 sessions total. Weekly sessions at Week 0, Week 1, Week 2, and Week 3. Final follow-up session at Week 7 (30 days after the 4th session). Provider: Physician with standardized training.

Arm 2: Semi-permanent Auricular Acupuncture (Group C) Location: Padua Center. Materials: Sterile semi-permanent needles (Seirin Pyonex, 0.15 x 6 mm). Procedure: Application of needles to the same left auricular points. Needles are retained in situ for 72 hours following application, then self-removed by the patient. Schedule: Application at Week 0, Week 1, Week 2, and Week 3. Final follow-up at Week 7. Provider: Physician with standardized training.
Intervention code [1] 332295 0
Treatment: Devices
Intervention code [2] 332296 0
Treatment: Devices
Description of the comparator or control
Comparator: Traditional Auricular Acupuncture (Group A) Type: Active Comparator. Location: Brescia Center. Materials: Sterile single-use acupuncture needles (Seirin Type B, 0.20 x 15 mm). Procedure: Insertion of needles into left auricular points (Chinese Kidney, Chinese Heart, SanJiao). Needles are maintained for 20 minutes without manual stimulation, then removed by the physician. Schedule: 5 sessions total. Weekly sessions at Week 0, Week 1, Week 2, and Week 3. Final follow-up session at Week 7. Provider: Physician with standardized training. Note: This group serves as the active control/comparator for the laser and semi-permanent techniques.
Control group
Active

Outcomes
Primary outcome [1] 343761 0
Depression Severity Score
Timepoint [1] 343761 0
Baseline (Week 0), Week 3 (primary endpoint), and Week 7 after start of intervention.
Primary outcome [2] 343973 0
Anxiety Severity Score
Timepoint [2] 343973 0
Baseline (Week 0), Week 3 (primary endpoint), and Week 7 after start of intervention.
Primary outcome [3] 343974 0
Stress Severity Score
Timepoint [3] 343974 0
Baseline (Week 0), Week 3 (primary endpoint), and Week 7 after start of intervention.
Secondary outcome [1] 453580 0
Heart Rate Variability - Low Frequency/High Frequency (LF/HF) ratio
Timepoint [1] 453580 0
Baseline (T0), Week 1 (T1) after start of intervention, Week 2 (T2) after start of intervention, Week 3 (T3) after start of intervention, and Week 7 (T4) after start of intervention.

Eligibility
Key inclusion criteria
- Age 18 years or older
- Diagnosis of anxiety, stress, and/or depression disorders according to DSM-5 criteria
- Ability to provide written informed consent
- Willingness to attend all scheduled treatment sessions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Pregnancy
- History of cardiovascular diseases
- History of pulmonary diseases
- Central nervous system diseases
- Substance use disorders
- Current treatment with beta-blockers
- Current treatment with anti-arrhythmic drugs

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)
Methods used to generate the sequence in which subjects will be randomised (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
Descriptive statistics are presented as mean plus or minus standard deviation and median with interquartile range (IQR: 25th to 75th percentile). Normal distribution was tested using the Shapiro-Wilk test. Intergroup comparisons were performed using the Kruskal-Wallis test with Dunn post-hoc analysis. Linear Mixed Effects Models (LMMs) were used to evaluate the longitudinal effects of the three therapeutic modalities on psychological outcomes (DASS-21) and on HRV (LF and HF components). To assess efficacy in modulating autonomic balance, the LF/HF ratio was analyzed and the derived Delta variable was calculated as the absolute value of (LF/HF minus 1). Statistical significance was set at p less than or equal to 0.05 after Bonferroni correction. Correlations were analyzed using Spearman correlation. Analyses were performed with STATA version 19. Missing data were not imputed; analyses were conducted using complete case analysis including only the 61 participants who completed all treatment sessions and assessments.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2023
Date of last participant enrolment
Anticipated
Actual
30/10/2024
Date of last data collection
Anticipated
Actual
20/12/2024
Sample size
Target
63
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 27486 0
Italy
State/province [1] 27486 0

Funding & Sponsors
Funding source category [1] 321061 0
Self funded/Unfunded
Name [1] 321061 0
Dr Antonello Lovato
Country [1] 321061 0
Italy
Primary sponsor type
Other Collaborative groups
Name
A.I.R.A.S. (Italian Association for the Research and the Scientific Update)
Address
Country
Italy
Secondary sponsor category [1] 322851 0
None
Name [1] 322851 0
Address [1] 322851 0
Country [1] 322851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318826 0
Ethics Committee of A.I.R.A.S. (Italian Association for Research and Scientific Update)
Ethics committee address [1] 318826 0
Ethics committee country [1] 318826 0
Italy
Date submitted for ethics approval [1] 318826 0
15/11/2022
Approval date [1] 318826 0
15/12/2022
Ethics approval number [1] 318826 0
AIRAS 01012023-CR

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

Contacts
Principal investigator
Name 145390 0
Dr Antonello Lovato
Address 145390 0
Pain Therapy Clinic, Via Nazario Sauro 29, 36045 Lonigo (Vicenza)
Country 145390 0
Italy
Phone 145390 0
+390444832740
Fax 145390 0
Email 145390 0
[email protected]
Contact person for public queries
Name 145391 0
Antonello Lovato
Address 145391 0
Pain Therapy Clinic, Via Nazario Sauro 29, 36045 Lonigo (Vicenza)
Country 145391 0
Italy
Phone 145391 0
+390444832740
Fax 145391 0
Email 145391 0
[email protected]
Contact person for scientific queries
Name 145392 0
Antonello Lovato
Address 145392 0
Pain Therapy Clinic, Via Nazario Sauro 29, 36045 Lonigo (Vicenza)
Country 145392 0
Italy
Phone 145392 0
+390444832740
Fax 145392 0
Email 145392 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone

• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests for individual de-identified participant data should be directed to the corresponding author:

Dr. Antonello Lovato
Email: [email protected]

Requests should include:
- Research proposal with scientific rationale
- Description of intended data use
- Evidence of institutional ethics approval

Data will be provided in anonymized format following review and approval of the request, and execution of a data sharing agreement.

• Postal address: Via Nazario Sauro 29, 36045 Lonigo (Vicenza), Italy

Are there extra considerations when requesting access to individual participant data?
No


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.