Cyclical Sighing for Pain

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Cyclical Sighing; Behavioral: Pain Coping Information

• Registration Number: NCT06292793
• Lead Sponsor: Florida State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-13
• Study First Submitted: 2023-12-13
• Status Verified: 2024-02
• Primary Completion: 2024-02-26
• Study Completion: 2024-02-26
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclical Sighing	Cyclical Sighing	-
Pain Coping Information	Pain Coping Information	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	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 Outcome Measures

Name	Time	Method
Change in Anxiety Numeric Rating Scale	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.
Change in Pain Intensity Numeric Rating Scale	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.
Change in Depression Numeric Rating Scale	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.

Trial Locations

Locations (1)

Tallahassee Orthopedic Clinic (TOC); 🇺🇸 Tallahassee, Florida, United States