Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000497404
Ethics application status
Approved
Date submitted
24/09/2007
Date registered
28/09/2007
Date last updated
28/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in stress-related physical and mental effort.
Scientific title
A Randomised study to evaluate the effectiveness of Neuro Psycho Physical Optimization (NPPO) with Conveyer of Modulating Radiance (CMR Therapy) in reducing the subjective perception of stress, stress-related physical and mental effort.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress, Stress-related physical and mental effort. 2390 0
Condition category
Condition code
Mental Health 2493 2493 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises: A cycle of Neuro Psycho Physical Optimization (NPPO) with Conveyer of Modulating Radiance (CMR therapy). The CMR is a biomedical radiofrequency instrument. The protocol used, called Neuro Psycho Physical Optimization (ONPF), involves the application of a probe of the CMR 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 on alternating days, for eight (8)weeks. Assessment, at baseline and at the end of treatment, with Psychological Stress Measure Test (validated in Italian).
Intervention code [1] 2115 0
Treatment: Devices
Comparator / control treatment
The reduction of the subjective perception of stress and stress-related physical and mental effort, after an NPPO cycle with CMR device, shows significant results (P<.05), respect to a control group that was treated with placebo (inactivated CMR) for the same period of 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3390 0
To test with Psychological Stress Measure if the use of the Conveyer of Modulating Radiance (CMR) - is effective in reducing the subjective perception of stress and stress-related physical and mental effort.
Timepoint [1] 3390 0
At time zero and immediately after the cycle of therapy.
Secondary outcome [1] 5625 0
Wellbeing - Neuro Psycho Physical Optimization.
Timepoint [1] 5625 0
At time zero and immediately after the cycle of therapy.

Eligibility
Key inclusion criteria
Subjects with any type of stress-related symptomatology, over 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with psychiatric symptoms-pathologies, drugs dependence or aged less than 18 years of age were excluded.

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, concealed way, 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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment outside Australia
Country [1] 604 0
Italy
State/province [1] 604 0

Funding & Sponsors
Funding source category [1] 2643 0
Charities/Societies/Foundations
Name [1] 2643 0
Istituto Rinaldi Fontani
Country [1] 2643 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2391 0
Charities/Societies/Foundations
Name [1] 2391 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2391 0
Via Nazionale 23 50123 Firenze
Country [1] 2391 0
Italy
Other collaborator category [1] 49 0
University
Name [1] 49 0
University of Firenze - Department of Public Medicine - Occupational Health - Master of Second Level Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 49 0
Largo Palagi 1 - 50139 Firenze
Country [1] 49 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4561 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Ethics committee address [1] 4561 0
Via Nazionale 23 50123 Firenze
Ethics committee country [1] 4561 0
Italy
Date submitted for ethics approval [1] 4561 0
09/11/2000
Approval date [1] 4561 0
09/11/2000
Ethics approval number [1] 4561 0

Summary
Brief summary
Physical and mental effort are the most frequent signs of general distress. In this study we have used the Psychological Stress Measure (validated in Italian) to test the effectiveness of Neuro Psycho Physical Optimization (NPPO) with Conveyer of Modulating Radiance - CMR Therapy in reducing the subjective perception of stress and stress-related physical and mental effort. The reduction of the symptomatology of stress and stress-related physical and mental effort after a NPPO cycle with CMR therapy shows significant results (P<.05) with respect to a control group that was treated with placebo (inactivated CMR).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28065 0
Address 28065 0
Country 28065 0
Phone 28065 0
Fax 28065 0
Email 28065 0
Contact person for public queries
Name 11222 0
Vania Fontani M.D.
Address 11222 0
Via Nazionale 23 50123 Firenze
Country 11222 0
Italy
Phone 11222 0
+39 055 290307
Fax 11222 0
Email 11222 0
[email protected]
Contact person for scientific queries
Name 2150 0
Salvatore Rinaldi M.D
Address 2150 0
Via Nazionale 23 50123 Firenze
Country 2150 0
Italy
Phone 2150 0
+39 055 290307
Fax 2150 0
Email 2150 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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