4th Ventricular Compression Technique on Anxiety

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: 4th Ventricular Compression Technique; Other: "Sham" Therapy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natália MO Campelo, PhD; Phone Number: 22 206 1000; Email: nmc@ess.ipp.pt
• Study Contact Backup: Name: Natália MO Campelo; Phone Number: 22 206 1000; Email: nmc@ess.ipp.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Escola Superior da Saúde do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4th Ventricular Compression Technique; The technique was preformed by the investigator during 5 minutes.	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.
Placebo Comparator: "Sham" Therapy; The technique was preformed by the investigator during 5 minutes.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde do Porto
• Investigators: Principal Investigator: Natália MO Natália, Escola Superior da Saúde do Porto

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; College Students; CV4; Osteopathic treatment
• Other Study ID Numbers: OST1_012

Plan for Individual participant data (IPD)

Study Data/Documents

1. Castilloa, A. R. G. L., Recondob, R., Asbahrc, F. R. & Manfrod, G. G. (2000).
   Information comments: Transtornos de ansiedade. Revista Brasileira de Psiquiatria. 22(2), 20-23.
2. 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).
   Information comments: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No