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NCT Number: NCT05323383

The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain

The aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. Participants will be randomly assigned to condition. The dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. The active treatments are hypothesized to produce greater reductions in pain outcomes than the control. It is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. Moderators of response will also be explored.

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Key information

Conditions

Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location status: Recruiting

Location contact

Melissa Day, Ph.D.

CONTACT

[email protected]

+61 7 3365 6421

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 18 years of age;
  • Experience chronic or recurrent pain;
  • Have access to a computer, phone or tablet with internet capability; and
  • Be able to read and understand English.

Treatment and study plan

Mindfulness Meditation

Behavioral

Participants in the mindfulness meditation condition will listen to a 20minute guided mindfulness meditation practice that holds the breath and body as the object of meditation.

Self-hypnosis

Behavioral

Participants in self-hypnosis will listen to a 20-minute audio-guided hypnosis practice with an induction phase, followed by suggestions tailored towards shifts in affect and decentering, and then a re-alerting with post-hypnotic suggestions phase.

Attention Control

Other

Control participants will listen to a 20-minute natural history recording which was chosen as past research has found that individuals who listen to it report this to be a neutral, but relaxing passage, and it has been used as an effective control condition in previous research.

Primary outcomes

  1. Current pain intensity

    Time frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

    Numerical rating scale ranging from 0-10

  2. Current pain unpleasantness

    Time frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

    Numerical rating scale ranging from 0-10

Secondary outcomes

  1. Mechanism: Mindfulness

    Time frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

    State Mindfulness Scale with items ranging from 1-5

  2. Mechanism: Positive Affect

    Time frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

    PANAS-X

  3. Mechanism: Decentering

    Time frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

    State decentering MpoD-s

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Day, Ph.D.

CONTACT

[email protected]

+61 7 3365 6421

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • University of Washington

Registry information

Official study title

The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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