Recruiting NCT07562412
Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1-Minute Mindfulness Intervention, 2-Minute Mindfulness Intervention, 3-Minute Mindfulness Intervention.
- Who it may be relevant to
- Registry conditions: Pain, Pain Management, Mindfulness, Orthopedic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain While Awaiting Orthopedic Care
Overview
This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.
Interventions
- Behavioral 1-Minute Mindfulness Intervention
Participants listen to a 1-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it. - Behavioral 2-Minute Mindfulness Intervention
Participants listen to a 2-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it. - Behavioral 3-Minute Mindfulness Intervention
Participants listen to a 3-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.
Primary outcome measures
- Change in Pain Unpleasantness Numeric Rating Scale [Time frame: Immediately before to after the 1- to 3-minute audio recording]
Secondary outcome measures (1)
- Change in Pain Intensity Numeric Rating Scale [Time frame: Immediately before to after the 1- to 3-minute audio recording]
Eligibility criteria
Inclusion criteria
- Receiving treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
Exclusion criteria
- Unable to consent because of physical or mental incapacity.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tallahassee Orthopedic Clinic — Tallahassee
Identifiers
NCT: NCT07562412 · STUDY00004916_Dose