Cyclical Sighing for Pain
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Dec 2023
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedMarch 5, 2024
February 1, 2024
3 months
December 13, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Pain Intensity Numeric Rating Scale
Immediately after the 4-minute audio recording
Change in Anxiety Numeric Rating Scale
Immediately after the 4-minute audio recording
Change in Depression Numeric Rating Scale
Immediately after the 4-minute audio recording
Study Arms (2)
Pain Coping Information
ACTIVE COMPARATORCyclical Sighing
EXPERIMENTALInterventions
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice.
Eligibility Criteria
You may qualify if:
- Age ≥18
- Seeking treatment at the Tallahassee Orthopedic Clinic
You may not qualify if:
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study involvement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308, United States
Related Publications (1)
Hanley AW, Davis A, Worts P, Pratscher S. Cyclic sighing in the clinic waiting room may decrease pain: results from a pilot randomized controlled trial. J Behav Med. 2025 Apr;48(2):385-393. doi: 10.1007/s10865-024-00548-5. Epub 2025 Feb 4.
PMID: 39904867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 13, 2023
First Posted
March 5, 2024
Study Start
December 13, 2023
Primary Completion
February 26, 2024
Study Completion
February 26, 2024
Last Updated
March 5, 2024
Record last verified: 2024-02