Pain, PostoperativeNCT03512587
Personalized Quantum Sonotherapy in Regional Anesthesia
A study testing Personalized quantum sonotherapy in people with Pain, Postoperative and Anxiety, run by CES University at 1 site in Colombia.
Trial summary
The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anxiety
- What is being tested?
- Personalized quantum sonotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2017to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
- Age between 18 and 60 years.
- Patients with anesthetic risk ASA 1 and 2.
- Patients without contraindications for the administration of opioids and benzodiazepines.
- Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
- Patients with an adequate level of understanding, who are able to communicate by telephone and understand a numerical scale.
- Patients who agree to participate in the work.
Who cannot join
- Patients with auditory and cognitive problems.
- Patients requiring general anesthesia at some time during the intraoperative period.
- Patients with morbid obesity.
- Patients consuming anxiolytics in the last month.
- Patients whose start of surgery is after 45 minutes of the blockade.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).
- Conditions
- Pain, Postoperative, Anxiety
- Being tested
- Personalized quantum sonotherapy, Placebo
- Keywords
- Personalized quantum sonotherapy, Regional anesthesia, Peripheral nerve block
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized quantum sonotherapyProcedure or surgery
Quantum sonotherapy is an alternative non-pharmacological treatment that effects a molecular reorganization that occurs after the sound stimulus. The audible words and their waves have the ability to generate vibrations and stimulate the psycho-neuro-endocrine chain, independent of the semantic meaning of the words. It is an alternative therapy that uses non-musical sound waves.
PlaceboProcedure or surgery
Headphones will be place in patients without playing quantum sonotherapy
| Study group | Role | What they receive |
|---|---|---|
| Personal quantum sonotherapy group | Experimental | Patients who will listen through MP3 devices the personalized quantum sonotherapy previously created through a especialized software, before the application of regional anesthesia. Receives: Procedure: Personalized quantum sonotherapy |
| Control group | Placebo comparator | Patients will wear headphones but without playing the personalized quantum sonotherapy Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
To assess the effect of personalized quantum sonotherapy on the level of pain of patients taken to orthopedic surgery under regional anesthesia through pain score visual analoge score (VAS). VAS ranges from 0 to 10 being 0 no pain an 10 the worst pain ever felted. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Measured: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
Anxiety
To assess the effect of personalized quantum sonotherapy on the level of anxiety of patients taken to orthopedic surgery under regional anesthesia through anxiety score Questionnaire of anxious state STAI (Spielberger). STAI is a score to meausre anxiety, it has 20 questions each one with a possible value from 0 to 3 points. Total score is evaluated adding each score for each question, and it goes from 0 to 60 points, being 60 de higest score for anxiety. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Measured: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Feb 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Sofia Arango Gutierrez, CES University
- Investigators
- Mara P Gonzalez, MD, Principal investigator, University CES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512587
- Sponsor's protocol ID
- 645
- Status last verified
- Apr 2018
- First submitted
- 25 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03512587
- Acronym / sponsor ID
- 645
- Conditions
- Pain, Postoperative, Anxiety
- Keywords
- Personalized quantum sonotherapy, Regional anesthesia, Peripheral nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal quantum sonotherapy group | Experimental | Procedure: Personalized quantum sonotherapyPatients who will listen through MP3 devices the personalized quantum sonotherapy previously created through a especialized software, before the application of regional anesthesia. |
| Control group | Placebo comparator | Procedure: PlaceboPatients will wear headphones but without playing the personalized quantum sonotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
- Age between 18 and 60 years.
- Patients with anesthetic risk ASA 1 and 2.
- Patients without contraindications for the administration of opioids and benzodiazepines.
- Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
Key exclusion criteria (5 listed)
- Patients with auditory and cognitive problems.
- Patients requiring general anesthesia at some time during the intraoperative period.
- Patients with morbid obesity.
- Patients consuming anxiolytics in the last month.
- Patients whose start of surgery is after 45 minutes of the blockade.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized quantum sonotherapyQuantum sonotherapy is an alternative non-pharmacological treatment that effects a molecular reorganization that occurs after the sound stimulus. The audible words and their waves have the ability to generate vibrations and stimulate the psycho-neuro-endocrine chain, independent of the semantic meaning of the words. It is an alternative therapy that uses non-musical sound waves. | Procedure or surgery | Personal quantum sonotherapy group |
| PlaceboHeadphones will be place in patients without playing quantum sonotherapy | Procedure or surgery | Control group |
Primary outcome
Pain
Time frame: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
To assess the effect of personalized quantum sonotherapy on the level of pain of patients taken to orthopedic surgery under regional anesthesia through pain score visual analoge score (VAS). VAS ranges from 0 to 10 being 0 no pain an 10 the worst pain ever felted. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Anxiety
Time frame: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
To assess the effect of personalized quantum sonotherapy on the level of anxiety of patients taken to orthopedic surgery under regional anesthesia through anxiety score Questionnaire of anxious state STAI (Spielberger). STAI is a score to meausre anxiety, it has 20 questions each one with a possible value from 0 to 3 points. Total score is evaluated adding each score for each question, and it goes from 0 to 60 points, being 60 de higest score for anxiety. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara P Gonzalez, MD principal investigator
University CES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized quantum sonotherapy in people with Pain, Postoperative and Anxiety, run by CES University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.