Clinical trial NCT04786405: Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain
Official title: An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mindfulness Meditation
Clinical Hypnosis
Keywords: Mindfulness Meditation
Hypnosis
Acute Pain
Experimental Pain
Mechanisms
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, two-arm, parallel-group randomized design.
Primary purpose: TREATMENT

Brief summary: This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.

Detailed description: Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Able to read, speak and understand English.

Exclusion Criteria:

* Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
* Experience of recurrent fainting spells;
* Report of a chronic pain condition;
* Use of alcohol and/or pain medication in the last 24-hours;
* Currently receiving psychiatric care;
* Problems with allergic skin reactions or excessive bruising;
* Previous participation in a cold pressor experiment.
* All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.

These exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.

Primary outcomes:
measure: Pain unpleasantness
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Pain intensity
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Pain tolerance
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcomes:
measure: Physiological response to pain stimulus
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Attention Network Task
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Mind Wandering Task
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Mindfulness
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Pain catastrophizing
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Pain appraisals
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Pain-Related Cognitive Processes
timeFrame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
measure: Mechanism: Hypnotizability
timeFrame: Baseline score at Experimental Session 1 (Day 1)
measure: Mechanism: Pre-treatment expectancies
timeFrame: Baseline score at Experimental Session 1 (Day 1)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The University of Queensland
state: Queensland
Study officials:
References: