- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03647683
Self-Compassion and Acute Pain
Self-Compassion and Acute Pain - an Experimental Investigation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Self-compassion comprises three components: self-kindness, common humanity and mindfulness. Empirical evidence shows the relevance of self-compassion in the context of negative emotions such as depression, anxiety and anger. Research on chronic pain is promising yet limited. Self-compassion is associated with better pain-coping, pain-acceptance and quality of life, as well as reduced pain-related disability and burdening emotions. Experimental investigations on induced pain are missing. The aim of the current study is to evaluate a short self-compassion intervention for pain.
First, a heat stimulus is induced to all participants which is to be tolerated as long as possible and evaluated in intensity and unpleasantness. Next, participants receive a coping-strategy which they are randomly assigned to. Three different strategies are evaluated: (1) self-compassion, treating oneself with kindness while being mindfully aware of the painful stimulus, (2) acceptance, accepting the painful stimulus as well as pain-related thoughts, not trying to change, (3) distraction, distracting oneself from the painful stimulus and trying not to perceive the pain or painful thoughts. Participants practice the strategy with the painful heat stimulus three times. Then, they receive another heat stimulus which is to be tolerated as long as possible and evaluated. During the next week, participants obtain daily practices via e-mail for further fostering of the learned strategy. Finally, participants receive, tolerate and evaluate pain again in the laboratory.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hessen
-
Marburg, Hessen, Germany, 35032
- Philipps-University of Marburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sufficient german language knowledge
- at least 18 years old
Exclusion Criteria:
- acute or chronic pain conditions
- drug or pain-medication (last 24 hours)
- Raynaud's disease
- high blood pressure
- neuropathy, coronary diseases
- diabetes, current alcohol
- studying psychology longer than two years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Self-Compassion
After pretreatment heat pain assessment, participants are introduced to the concept of self-compassion.
Participants practice the new strategy with heat pain stimuli three times.
Next, the posttreatment pain assessment is conducted.
For a one week period, participants receive daily self-compassion audio-interventions.
Afterwards, the follow-up pain assessment is conducted.
|
Participants are introduced to the concept of self-compassion. Treating oneself with kindness, while being mindfully aware of the present moment as well as the fact that suffering is part of human life - a shared human experience. Participants are instructed to use this strategy to cope with the following heat stimulus.
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
|
|
EXPERIMENTAL: Acceptance
After pretreatment heat pain assessment, participants are introduced to the concept of acceptance.
Participants practice the new strategy with heat pain stimuli three times.
Next, the posttreatment pain assessment is conducted.
For a one week period, participants receive daily acceptance audio-interventions.
Afterwards, the follow-up pain assessment is conducted.
|
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
Participants are introduced to the concept of acceptance. Thoughts, Emotions and Reactions do not need to be related. Being aware of the present moment helps with accepting the present state and reacting contradictory to the thoughts and feelings. Participants are instructed to use this strategy to cope with the following heat stimulus. |
|
EXPERIMENTAL: Distraction
After pretreatment heat pain assessment, participants are introduced to the concept of distraction.
Participants practice the new strategy with heat pain stimuli three times.
Next, the posttreatment pain assessment is conducted.
For a one week period, participants receive daily distraction audio-interventions.
Afterwards, the follow-up pain assessment is conducted.
|
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
Participants are introduced to the concept of distraction. Distracting oneself from the present situation helps with not perceiving pain, painful thoughts or feelings. Participants are instructed to use this strategy to cope with the following heat stimulus. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Individual heat pain tolerance
Time Frame: Baseline, 45 min, 1 week
|
Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)
|
Baseline, 45 min, 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline, 45 min, 1 week
|
Change in subjective pain intensity assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain intensity)
|
Baseline, 45 min, 1 week
|
|
Change in pain unpleasantness scale
Time Frame: Baseline, 45 min, 1 week
|
Change in subjective pain unpleasentness assessed using a numeric rating scale (ranging from 0 to 10, with higher values reflecting more pain unpleasentness)
|
Baseline, 45 min, 1 week
|
|
Change in self-compassion
Time Frame: Baseline, 45 min, 1 week
|
Change in overall self-compassion assessed using the self-compassion scale (Neff, 2003) (higher values indicating higher self-compassion
|
Baseline, 45 min, 1 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anja C Schmitt, Philipps University Marburg Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-60v
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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