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Completed

NCT Number: NCT06292793

Cyclical Sighing for Pain

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18
  • Seeking treatment at the Tallahassee Orthopedic Clinic

Exclusion criteria

  • Cognitive impairment preventing completion of study procedures.
  • Other unstable illness judged by medical staff to interfere with study involvement.

Treatment and study plan

Pain Coping Information

Behavioral

A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Cyclical Sighing

Behavioral

A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: immediately after the 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: Immediately after the 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

  2. Change in Anxiety Numeric Rating Scale

    Time frame: Immediately after the 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing intense anxiety.

  3. Change in Depression Numeric Rating Scale

    Time frame: Immediately after the 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 representing intense depression.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Cyclical Sighing for Pain in an Orthopedic Clinic Waiting Room

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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