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Not yet recruitingNCT06389461Updated Apr 29, 2024

4th Ventricular Compression Technique on Anxiety

An interventional study of 4th Ventricular Compression Technique and "Sham" Therapy in Healthy, sponsored by Escola Superior de Tecnologia da Saúde do Porto. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Escola Superior de Tecnologia da Saúde do Porto · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy

Keywords

  • Anxiety
  • College Students
  • CV4
  • Osteopathic treatment
03

In context

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto is the lead sponsor of 37 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    4th Ventricular Compression Technique

    The technique was preformed by the investigator during 5 minutes.

    Other: 4th Ventricular Compression Technique

  • Placebo comparator
    "Sham" Therapy

    The technique was preformed by the investigator during 5 minutes.

    Other: "Sham" Therapy

Interventions

  • Other4th 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Immediately after last intervention

07

Study locations

1 site
  • Escola Superior da Saúde do Porto
    Porto, 4200-072, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06389461
Lead sponsor
Escola Superior de Tecnologia da Saúde do Porto
Responsible party
Natália Maria Oliveira Campelo (Professor, Escola Superior de Tecnologia da Saúde do Porto) — Principal investigator
First posted
Apr 29, 2024
Start date
Sep 16, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 29, 2024

Study contacts

Natália MO Campelo, PhD
Contact
nmc@ess.ipp.pt
22 206 1000
Natália MO Campelo
Contact
nmc@ess.ipp.pt
22 206 1000
Natália MO Natália
principal investigator · Escola Superior da Saúde do Porto

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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