An interventional study of Mindfulness Meditation and Clinical Hypnosis in Pain, Acute, sponsored by The University of Queensland. Withdrawn at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment
This study will utilize a replicated single case experimental design (RSCD) to investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving pain in injured elite athletes. The primary outcome is change in pain intensity. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.
The proposed program of research will utilize our current understanding of the Behavioral Inhibition System and Behavioral Activation System (BIS-BAS) model of pain and mind-body therapies and apply it to pain experienced by injured elite athletes. This study will be a replicated single case experimental design (RSCD), which will investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving the primary outcome of pain intensity in injured elite athletes. It will also investigate the potential mechanism role of change in cognitive content and cognitive processes in underlying the effects of these mind-body therapies. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.
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Inclusion Criteria:
Condition 1, Mindfulness Meditation (MM): The MM recording will be adapted from Day (2017). It will first instruct the listener to anchor attention on the breath while being mindfully aware of any physical sensations that arise throughout the body. The listener is then encouraged to explore sensations with non-judgmental attentiveness, without attempts to change the sensation in any way. This will implicitly provide training in mindful acceptance. Finally, the listener is instructed to simply label any thinking that arises as "thinking", before returning to the object of the meditation.
Behavioral: Mindfulness Meditation
Condition 2, Clinical Hypnosis (HYP): The HYP recording will be adapted from Jensen (2011). It will take the listener through a standardised self-hypnosis practice that includes an induction, followed by tailored suggestions. Specifically, the HYP session aims to take the listener through four basic ideas: 1) an induction to get the individual into a state of readiness to accept new ideas; 2) instructions to go to a favourite place to deepen the induction and provide a context for feeling heat while being relaxed; 3) linking suggestions for reducing automatic behavioural inhibition system and behavioural activation system (BIS-BAS) activation in response to stressors and enhancing awareness of when to activate each system; 4) suggestions that target enhancing self-confidence in pain management, well-being and the rehabilitation process; and 5) alerting.
Behavioral: Clinical Hypnosis
Five, 20-minute audio-recorded training sessions of mindfulness of breath and body meditation, practiced over consecutive days, delivered remotely via Qualtrics.
Five, 20-minute audio-recorded training sessions of clinical hypnosis with suggestions targeting pain management, practiced over consecutive days, delivered remotely via Qualtrics.
Numerical Rating Scale (NRS) of Current Pain Intensity
Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.
Time frame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Numerical Rating Scale (NRS) of Current Pain Unpleasantness
Change in pain unpleasantness will be measured using a 0-10 numerical rating scale (NRS) of average pain unpleasantness in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain unpleasantness. Higher scores indicate higher levels of self-reported pain unpleasantness.
Time frame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Depression Anxiety Stress Scale, 9-item SF, Stress Subscale
Change in general stress will be measured, with participants indicating how often they experience certain stress responses on a scale from 0 (never) to 3 (almost always).
Time frame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Positive and Negative Affect Schedule - Serene Affect Subscale
Change in serene affect will be measured with participants rating three adjectives describing serenity affect (i.e., relaxed, at ease, calm) on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely).
Time frame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Plan to share: No — Aggregate data will be made available for research purposes upon reasonable request once the data are published (within a time period of 5-years), with a data sharing agreement put in place.
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This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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The University of Queensland