None listed
Conditions
Brief summary
This multicenter controlled trial aims to evaluate and compare the therapeutic efficacy of three different auriculotherapy (ear acupuncture) stimulation modalities in the treatment of neuropsychiatric disorders. The study involves patients diagnosed with anxiety, stress, or depression, allocated to three parallel groups: traditional needle acupuncture (disorganization technique), laser therapy (modulation technique), or semi-permanent needles (modulation technique). The primary hypothesis is that different stimulation modalities—varying in intensity and duration—will produce differential effects on mood regulation and Autonomic Nervous System balance. Participants undergo a protocol of five sessions over seven weeks. The study utilizes the DASS-21 questionnaire and Heart Rate Variability (HRV) analysis to determine which modality offers the best clinical optimization for these conditions.
Interventions
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). Sti
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.
Sponsors
A.I.R.A.S. (Italian Association for the Research and the Scientific Update)
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed