4th Ventricular Compression Technique on Anxiety

NCT ID: NCT06389461

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2024-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

4th Ventricular Compression Technique

The technique was preformed by the investigator during 5 minutes.

Group Type: EXPERIMENTAL

4th Ventricular Compression Technique

Intervention Type: OTHER

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 technique was preformed by the investigator during 5 minutes.

Group Type: PLACEBO_COMPARATOR

"Sham" Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

"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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role: lead

Responsible Party

Natália Maria Oliveira Campelo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natália MO Natália

Role: PRINCIPAL_INVESTIGATOR

Escola Superior da Saúde do Porto

Locations

Escola Superior da Saúde do Porto

Porto, , Portugal

Countries

Portugal

Central Contacts

Natália MO Campelo, PhD

Role: CONTACT

nmc@ess.ipp.pt

22 206 1000

Natália MO Campelo

Role: CONTACT

nmc@ess.ipp.pt

22 206 1000

Study Documents

Document Type: Castilloa, A. R. G. L., Recondob, R., Asbahrc, F. R. & Manfrod, G. G. (2000).

Transtornos de ansiedade. Revista Brasileira de Psiquiatria. 22(2), 20-23.

View Document

Document Type: Abenavoli, A., Badi, F., Barbieri, M., Bianchi, M., Biglione, G., Dealessi, C., Grandini, M., Lavazza, C., Mapelli, L., Milano, V., Monti, L., Seppia, S., Tresoldi, M. & Maggiani, A. (2020).

Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study. Journal of Bodywork and Movement Therapies. 24(4), 215-221.

View Document

Other Identifiers

OST1_012

Identifier Type: -

Identifier Source: org_study_id