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Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

Primary Purpose

Mindfulness Meditation, Clinical Hypnosis

Status

Recruiting

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Mindfulness meditation

Clinical hypnosis

About this trial

This is an interventional treatment trial for Mindfulness Meditation focused on measuring Mindfulness Meditation, Hypnosis, Acute Pain, Experimental Pain, Mechanisms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The University of QueenslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Meditation

Clinical Hypnosis

Arm Description

Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days.

Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days.

Outcomes

Primary Outcome Measures

Pain unpleasantness

Numerical rating scale in response to exposure to a cold pressor task.

Pain intensity

Numerical rating scale in response to exposure to a cold pressor task.

Pain tolerance

How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.

Secondary Outcome Measures

Physiological response to pain stimulus

Heart rate data

Mechanism: Attention Network Task

A computer based task that has been developed to allow assessment of the functioning of the three major attentional networks; alerting, orienting, and executive attention.

Mechanism: Mind Wandering Task

A computer based task that has been developed to allow assessment of three types of mind wandering.

Mechanism: Mindfulness

Five Facet Mindfulness Questionnaire-Short Form

Mechanism: Pain catastrophizing

Pain Catastrophizing Scale

Mechanism: Pain appraisals

Pain Appraisal Inventory

Mechanism: Pain-Related Cognitive Processes

Pain-Related Cognitive Process Questionnaire34

Mechanism: Hypnotizability

Stanford Clinical Hypnotizability Scale

Mechanism: Pre-treatment expectancies

Treatment Expectations Questionnaire

Full Information

NCT ID

NCT04786405

First Posted

February 28, 2021

Last Updated

May 18, 2023

Sponsor

The University of Queensland

1. Study Identification

Unique Protocol Identification Number

NCT04786405

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2021 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Queensland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mindfulness Meditation, Clinical Hypnosis

Keywords

Mindfulness Meditation, Hypnosis, Acute Pain, Experimental Pain, Mechanisms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Single-blind, two-arm, parallel-group randomized design.

Masking

Outcomes Assessor

Masking Description

The experimenter will remain blind to participant condition.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Meditation

Arm Type

Experimental

Arm Description

Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days.

Arm Title

Clinical Hypnosis

Arm Type

Active Comparator

Arm Description

Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness meditation

Intervention Description

Participants in the mindfulness meditation condition will practice a breath and body focused meditation.

Intervention Type

Behavioral

Intervention Name(s)

Clinical hypnosis

Intervention Description

Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.

Primary Outcome Measure Information:

Title

Pain unpleasantness

Description

Numerical rating scale in response to exposure to a cold pressor task.

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Pain intensity

Description

Numerical rating scale in response to exposure to a cold pressor task.

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Pain tolerance

Description

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Secondary Outcome Measure Information:

Title

Physiological response to pain stimulus

Description

Heart rate data

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Attention Network Task

Description

A computer based task that has been developed to allow assessment of the functioning of the three major attentional networks; alerting, orienting, and executive attention.

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Mind Wandering Task

Description

A computer based task that has been developed to allow assessment of three types of mind wandering.

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Mindfulness

Description

Five Facet Mindfulness Questionnaire-Short Form

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Pain catastrophizing

Description

Pain Catastrophizing Scale

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Pain appraisals

Description

Pain Appraisal Inventory

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Pain-Related Cognitive Processes

Description

Pain-Related Cognitive Process Questionnaire34

Time Frame

Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Title

Mechanism: Hypnotizability

Description

Stanford Clinical Hypnotizability Scale

Time Frame

Baseline score at Experimental Session 1 (Day 1)

Title

Mechanism: Pre-treatment expectancies

Description

Treatment Expectations Questionnaire

Time Frame

Baseline score at Experimental Session 1 (Day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Day, PhD

Phone

+61 7 3365 6421

m.day@uq.edu.au

Facility Information:

Facility Name

The University of Queensland

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4072

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Day, PhD

Phone

+61 7 3365 6421

m.day@uq.edu.au

First Name & Middle Initial & Last Name & Degree

Melissa Day, PhD

First Name & Middle Initial & Last Name & Degree

Natasha Matthews, PhD

First Name & Middle Initial & Last Name & Degree

Mark Jensen, PhD

First Name & Middle Initial & Last Name & Degree

Jason Mattingley, PhD

First Name & Middle Initial & Last Name & Degree

Jonathan Davies, MSc

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).

Learn more about this trial

Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

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