NCT06485414

Brief Summary

Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders remains scant. This study aims to analyze the correlation between central sensitization and breathing pattern disorders in adults by assessing both respiration and pain.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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

June 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

28 days

First QC Date

June 25, 2024

Last Update Submit

June 29, 2024

Conditions

Keywords

central sensitizationbreathing pattern disorderschronic pain

Outcome Measures

Primary Outcomes (1)

  • Respiratory function

    This study utilized the Self Evaluation of Breathing Questionnaire (SEBQ) to assess respiratory function. The SEBQ is a self-administered questionnaire designed to measure symptoms and severity associated with respiratory dysfunction. It consists of 25 items, each rated on a 4-point scale (0 = not at all, to 3 = very much so), with a total possible score ranging from 0 to 75. While there is no definitive cutoff score for the SEBQ, experts consider a total score above 25 to indicate a problem with respiratory function. The SEBQ has a test-retest reliability (ICC) of 0.89 and internal consistency (Cronbach's α) of 0.93.

    During the assessment period

Study Arms (1)

central sensitization

Individuals who scored above 40 on the Central Sensitization Inventory for Koreans (CSI-K) assessment.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were voluntarily recruited from church members who complained of symptoms of central sensitization and were registered according to the inclusion and exclusion criteria.

You may qualify if:

  • Adults aged 18 and above.
  • Individuals scoring 40 or above on the Central Sensitization Inventory for Koreans (CSI-K).
  • Individuals who consent to the use and publication of their personal information and wish to participate in assessment measurements.

You may not qualify if:

  • Individuals with pulmonary, cardiac, or respiratory diseases.
  • Individuals with severe hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
  • Individuals with cognitive impairments.
  • Individuals who express a desire to withdraw from the study during its duration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Honam University

Gwangju, 62399, South Korea

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hyunjoong Kim, PhD

    Gwangju Health University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeonmo Im, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 3, 2024

Study Start

July 3, 2024

Primary Completion

July 31, 2024

Study Completion

August 31, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations