NCT06389461

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 16, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

AnxietyCollege StudentsCV4Osteopathic treatment

Outcome Measures

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.

    One week after the last intervention

Secondary Outcomes (1)

  • Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention

    Immediately after last intervention

Study Arms (2)

4th Ventricular Compression Technique

EXPERIMENTAL

The technique was preformed by the investigator during 5 minutes.

Other: 4th Ventricular Compression Technique

"Sham" Therapy

PLACEBO COMPARATOR

The technique was preformed by the investigator during 5 minutes.

Other: "Sham" Therapy

Interventions

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.

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 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.

"Sham" Therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Natália MO Natália

    Escola Superior da Saúde do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

Natália MO Campelo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 29, 2024

Study Start

September 16, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations