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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03647683
Other study ID # 2017-60v
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date November 30, 2018

Study information

Verified date April 2019
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Germany Philipps-University of Marburg Marburg Hessen

Sponsors (1)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual heat pain tolerance 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 Pain intensity 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
Secondary Change in pain unpleasantness scale 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
Secondary Change in self-compassion Change in overall self-compassion assessed using the self-compassion scale (Neff, 2003) (higher values indicating higher self-compassion Baseline, 45 min, 1 week
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