4th Ventricular Compression Technique on Anxiety

Healthy Clinical Trial

Official title:

The Efficacy of the 4th Ventricular Compression Technique on Anxiety in Students: RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389461
• Other study ID #: OST1_012
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 16, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: Natália MO Campelo, PhD
• Phone: 22 206 1000
• Email: nmc[@]ess.ipp.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 4th Ventricular Compression Technique
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" Therapy
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.

Locations

Country	Name	City	State
Portugal	Escola Superior da Saúde do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One week after the last intervention
Secondary	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.	Immediately after last intervention