HealthyNCT06389461
4th Ventricular Compression Technique on Anxiety
A study testing 4th Ventricular Compression Technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 4th Ventricular Compression Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Sep 2024to 31 Dec 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 18 and 25 years old;
- Be a college/university student;
- Not have knowledge of the technique used;
- Achieve a 20 plus score on the State-Trait Anxiety Inventory questionnaire.
Who cannot join
- Use of pharmacological therapy for psychological disorders;
- Presence of conditions that prevent or contraindicate the technique, including tumors, fractures, dislocations, vertebrobasilar insufficiency, bone diseases, neurological diseases, fever, skin diseases, cardiovascular diseases, psychiatric diseases, increased intracranial pressure.
- Surgeries or traumas in the specific areas of the technique;
- Pregnancy;
- Osteopathic treatments or other manual therapies aimed at reducing anxiety;
- Evident postural alteration or deformity of the thoracic cage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of the 4th Ventricular Compression Technique on Anxiety in Students: RCT
Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks.
Read the detailed description
The anxiety is a warning sign that makes it possible for the individual to defend themselves and protect themselves from threats. This is considered a natural and necessary reaction for self-preservation. However, when it appears persistently, exaggeratedly or disproportionately in relation to a stimulus, the following are considered: pathological anxiety.
The compression of the fourth ventricle (CV4) is one of the most well-known procedures in the practice of cranial manipulation. It is also one of the most clinically tested techniques and has been postulated to be associated with decreased sympathetic tone.
Therefore, this was the chosen technique, as it significantly affects the relaxation of the SNS tonus and, thereafter, anxiety.
- Conditions
- Healthy
- Being tested
- 4th Ventricular Compression Technique, "Sham" Therapy
- Keywords
- Anxiety, College Students, CV4, Osteopathic treatment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4th Ventricular Compression TechniqueOther
The investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard.
The investigator joins hands in a cupping position, with the pads of the 1st fingers forming a triangle. The pads of the 1st fingers make contact with the spinous processes of the 2nd and 3rd cervical vertebrae. The thenar eminences make contact with the occipital squama, avoiding contact with the occipito-mastoid sutures during 5 minutes.
A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique.
"Sham" TherapyOther
The investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard.
The investigator places hands on the patient's shoulders during 5 minutes. A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique.
| Study group | Role | What they receive |
|---|---|---|
| 4th Ventricular Compression Technique | Experimental | The technique was preformed by the investigator during 5 minutes. Receives: Other: 4th Ventricular Compression Technique |
| "Sham" Therapy | Placebo comparator | The technique was preformed by the investigator during 5 minutes. Receives: Other: "Sham" Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention.
The participants were submitted to a evaluation 1 week prior the 1st and 1 week after the last intervention. The corresponding questionnaires were sent to the researchers so that they could record the information. Quoted with a min. of 20 points and a max. of 80 - higher the score worst level of anxiety.
Measured: One week after the last intervention
Secondary outcomes (1)
Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention
The participants were submitted to a evaluation/ measurement in the 1st and last intervention. The corresponding results were registered by the researchers so that they could record the information.
Measured: Immediately after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start16 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Natália, Principal investigator, Escola Superior da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389461
- Sponsor's protocol ID
- OST1_012
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the 4th Ventricular Compression Technique on Anxiety in Students: RCT
- ClinicalTrials.gov ID
- NCT06389461
- Acronym / sponsor ID
- OST1_012
- Conditions
- Healthy
- Keywords
- Anxiety, College Students, CV4, Osteopathic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks.
Detailed description
The anxiety is a warning sign that makes it possible for the individual to defend themselves and protect themselves from threats. This is considered a natural and necessary reaction for self-preservation. However, when it appears persistently, exaggeratedly or disproportionately in relation to a stimulus, the following are considered: pathological anxiety.
The compression of the fourth ventricle (CV4) is one of the most well-known procedures in the practice of cranial manipulation. It is also one of the most clinically tested techniques and has been postulated to be associated with decreased sympathetic tone.
Therefore, this was the chosen technique, as it significantly affects the relaxation of the SNS tonus and, thereafter, anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4th Ventricular Compression Technique | Experimental | Other: 4th Ventricular Compression TechniqueThe technique was preformed by the investigator during 5 minutes. |
| "Sham" Therapy | Placebo comparator | Other: "Sham" TherapyThe technique was preformed by the investigator during 5 minutes. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages between 18 and 25 years old;
- Be a college/university student;
- Not have knowledge of the technique used;
- Achieve a 20 plus score on the State-Trait Anxiety Inventory questionnaire.
Key exclusion criteria (6 listed)
- Use of pharmacological therapy for psychological disorders;
- Presence of conditions that prevent or contraindicate the technique, including tumors, fractures, dislocations, vertebrobasilar insufficiency, bone diseases, neurological diseases, fever, skin diseases, cardiovascular diseases, psychiatric diseases, increased intracranial pressure.
- Surgeries or traumas in the specific areas of the technique;
- Pregnancy;
- Osteopathic treatments or other manual therapies aimed at reducing anxiety;
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 |
|---|---|---|
| 4th Ventricular Compression TechniqueThe investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard. The investigator joins hands in a cupping position, with the pads of the 1st fingers forming a triangle. The pads of the 1st fingers make contact with the spinous processes of the 2nd and 3rd cervical vertebrae. The thenar eminences make contact with the occipital squama, avoiding contact with the occipito-mastoid sutures during 5 minutes. A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique. | Other | 4th Ventricular Compression Technique |
| "Sham" TherapyThe investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard. The investigator places hands on the patient's shoulders during 5 minutes. A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique. | Other | "Sham" Therapy |
Primary outcome
Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention.
Time frame: One week after the last intervention
The participants were submitted to a evaluation 1 week prior the 1st and 1 week after the last intervention. The corresponding questionnaires were sent to the researchers so that they could record the information. Quoted with a min. of 20 points and a max. of 80 - higher the score worst level of anxiety.
1 secondary outcome
Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention
Time frame: Immediately after last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Natália MO Natália principal investigator
Escola Superior da Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4th Ventricular Compression Technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (22 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention. (time frame: One week after the last intervention). 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 29 Apr 2024.