Self-Compassion and Acute Pain

April 8, 2019 updated by: Philipps University Marburg Medical Center

Self-Compassion and Acute Pain - an Experimental Investigation

Research on self-compassion suggests its impact in the context of pain. In the current study, the investigators evaluate a short self-compassion intervention for coping with acute pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35032
        • Philipps-University of Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Self-Compassion

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.

Other: Heat pain
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.
Other: Heat pain
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
Other: Acceptance

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.
Other: Heat pain
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
Other: Distraction

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anja C Schmitt, Philipps University Marburg Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-60v

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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