Cyclical Sighing for Pain

Pain Clinical Trial

Official title:

Cyclical Sighing for Pain in an Orthopedic Clinic Waiting Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06292793
• Other study ID #: STUDY00004696
• Status: Completed
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: February 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Pain Coping Information
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
• Cyclical Sighing
A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice.

Locations

Country	Name	City	State
United States	Tallahassee Orthopedic Clinic (TOC)	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Unpleasantness Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.	immediately after the 4-minute audio recording
Secondary	Change in Pain Intensity Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.	Immediately after the 4-minute audio recording
Secondary	Change in Anxiety Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing intense anxiety.	Immediately after the 4-minute audio recording
Secondary	Change in Depression Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 representing intense depression.	Immediately after the 4-minute audio recording