Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000484246
Ethics application status
Approved
Date submitted
12/06/2009
Date registered
18/06/2009
Date last updated
18/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single blinded evaluation of the effectiveness of Neuro Psycho Physical Optimization protocol with Radio Electric Asymmetric Conveyer in stress-related disorders, assessed with Symptom Checklist-90 (SCL-90) and Psychological Stress Measure Test.
Scientific title
Single blinded evaluation of the effectiveness of Neuro Psycho Physical Optimization protocol with Radio Electric Asymmetric Conveyer in stress-related disorders, assessed with Symptom Checklist-90 (SCL-90) and Psychological Stress Measure Test.
Universal Trial Number (UTN)
Trial acronym
sbsclmsp
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emotional and psychophysical disorders stress related 236981 0
Condition category
Condition code
Mental Health 237324 237324 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises: A cycle of auricular treatment protocol with Radioelectric Asymetric Conveyer (REAC). The REAC is a Radioelectric medical device. The protocol used, called Neuro Psycho Physical Optimization (ONPF), involves the application of a probe of the REAC on specific points of the auricular pavilion for an activation time of roughly 500 mms. The ONPF protocol is activated in a precise sequence on seven auricular points. . The protocol envisages 18 sessions of ONPF treatment lasting approximately 3,5 seconds each on alternating days, for eight (8) weeks. Assessment, at baseline and immediately at the end of treatment, with SCL-90 and Psychological Stress Measure Test
Intervention code [1] 236748 0
Treatment: Devices
Comparator / control treatment
Evaluate the effectiveness on the subjective perception of stress and stress-related symptom between the treated group and the placebo group (treted with inactive REAC).The inactive REAC is the exact same machine but with a modified probe. The frequency and overall duration in which the inactive REAC will be applied, is the same as for the intervention group, 18 sessions of treatment on alternating days lasting 3,5 seconds per session for eight (8) weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 238144 0
To test if the use of the Neuro Psycho Physical Optimization (ONPF) auricular protocol with REAC - is effective in reducing the subjective perception of stress, and stress-related symptoms, assessed with SCL-90 and Psychological Stress Measure Test
Timepoint [1] 238144 0
At time zero and immediatly after the therapy cycle.
Secondary outcome [1] 242358 0
Wellbeing assessed with Psychological stress measure test (PSM)
Timepoint [1] 242358 0
At time zero and immediatly after the therapy cycle.

Eligibility
Key inclusion criteria
Healthy Subjects without organic diseases, over 18 years old, who claimed to be stressed, with any type of stress-related symptoms and with Psychological stress measure test (PSM) total score over 45 points. No history of drug abuse, nor severe mental illness or personality disorder. No medications, known to affect cognitive functioning nor undergoing psychological interventions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of psychiatric pathology, organic central nervous system (CNS) pathology, preceding skull traumas with loss of conscience longer than 5 minutes, dementia, alcohol dependence, current therapy with medications known to affect cognitive functioning.

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)
The subjects, blindway, was allocated randomly to treatment or control group by an external operator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by an external operator - computerized sequence generation at the reception desk
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Only doctors who administered treatment knew whether it was real or placebo. The normal and the placebo REAC device will be indistinguishable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 1832 0
Italy
State/province [1] 1832 0

Funding & Sponsors
Funding source category [1] 237143 0
Charities/Societies/Foundations
Name [1] 237143 0
Istituto Rinaldi Fontani
Country [1] 237143 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23, 50123 Firenze
Country
Italy
Secondary sponsor category [1] 4634 0
Charities/Societies/Foundations
Name [1] 4634 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 4634 0
Via Nazionale 23, 50123 Firenze
Country [1] 4634 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239236 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Ethics committee address [1] 239236 0
Via Nazionale 23 50123 Firenze
Ethics committee country [1] 239236 0
Italy
Date submitted for ethics approval [1] 239236 0
Approval date [1] 239236 0
Ethics approval number [1] 239236 0

Summary
Brief summary
The aim of this study is evaluate the efficacy of the Neuro Psycho Physical Optimization (NPPO) protocol treatment with Radioelectric Asymmetric Conveyer (REAC) in the improvement of the psychic and symptomatic stress-related disorders in a group of subjects revealing high values of psychological stress. These randomized, single-blinded controlled study, was conducted on subjects that voluntarily came to our Institute declaring to “feel stressed”. One hundred twenty four (124) subjects (females, n = 81, males, n = 43) with psychological distress symptoms, were recruited an randomized to REAC therapy or placebo.
Eighteen sessions of NPPO protocol treatment with REAC, or placebo (inactivated REAC), was applied to seven specific points of the auricular pavilion and were administered on alternate days, lasting about four weeks. Psychological stress symptoms were assessed by Psychological Stress Measure (PSM) and Symptomatic Check List (SCL-90), pre and post intervention. Data were analyzed using the Statistical Package for Social Sciences (SPSS), version 13.0
Data conformed to a Gaussian distribution. There was a significant reduction in PSM test and SCL-90 scores in the treated group as compared to the placebo group. Results of the psychometric tests showed that the subjects that underwent the effective therapy showed a statistically relevant reduction in their level of stress and psychological disorders compared to the control placebo group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29736 0
Address 29736 0
Country 29736 0
Phone 29736 0
Fax 29736 0
Email 29736 0
Contact person for public queries
Name 12983 0
Fontani Vania M.D.
Address 12983 0
Via Nazionale 23 50123 Firenze
Country 12983 0
Italy
Phone 12983 0
+39 055 290307
Fax 12983 0
Email 12983 0
[email protected]
Contact person for scientific queries
Name 3911 0
Salvatore Rinaldi M.D.
Address 3911 0
Via Nazionale 23 50123 Firenze
Country 3911 0
Italy
Phone 3911 0
+39 055 290307
Fax 3911 0
Email 3911 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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