Cyclical Sighing for Pain

Cyclical Sighing for Pain in an Orthopedic Clinic Waiting Room

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Pain Coping Information; Behavioral: Cyclical Sighing

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Orthopedic Clinic (TOC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pain Coping Information	Behavioral: Pain Coping Information; A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Experimental: Cyclical Sighing	Behavioral: Cyclical Sighing; A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No