Acute PainNCT03647683
Self-Compassion and Acute Pain
A study testing Self-Compassion, Acceptance and Distraction in people with Acute Pain, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Self-Compassion, Acceptance and Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sufficient german language knowledge
- at least 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Pain
- Being tested
- Self-Compassion, Acceptance, Distraction, Heat pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-CompassionOther
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.
AcceptanceOther
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.
DistractionOther
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 painOther
Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion | Experimental | 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. Receives: Other: Self-Compassion; Other: Heat pain |
| Acceptance | Experimental | 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. Receives: Other: Acceptance; Other: Heat pain |
| Distraction | Experimental | 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. Receives: Other: Distraction; Other: Heat pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual heat pain tolerance
Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)
Measured: Baseline, 45 min, 1 week
Secondary outcomes (3)
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)
Measured: Baseline, 45 min, 1 week
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)
Measured: Baseline, 45 min, 1 week
Change in self-compassion
Change in overall self-compassion assessed using the self-compassion scale (Neff, 2003) (higher values indicating higher self-compassion
Measured: Baseline, 45 min, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Apr 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja C Schmitt, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647683
- Sponsor's protocol ID
- 2017-60v
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Compassion and Acute Pain - an Experimental Investigation
- ClinicalTrials.gov ID
- NCT03647683
- Acronym / sponsor ID
- 2017-60v
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion | Experimental | Other: Self-Compassion, Other: Heat painAfter 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. |
| Acceptance | Experimental | Other: Acceptance, Other: Heat painAfter 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. |
| Distraction | Experimental | Other: Distraction, Other: Heat painAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sufficient german language knowledge
- at least 18 years old
Key exclusion criteria (7 listed)
- acute or chronic pain conditions
- drug or pain-medication (last 24 hours)
- Raynaud's disease
- high blood pressure
- neuropathy, coronary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-CompassionParticipants 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 | Self-Compassion |
| AcceptanceParticipants 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. | Other | Acceptance |
| DistractionParticipants 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. | Other | Distraction |
| Heat painParticipants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects. | Other | Acceptance, Distraction, Self-Compassion |
Primary outcome
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)
3 secondary outcomes
Pain intensity
Time frame: Baseline, 45 min, 1 week
Change in pain unpleasantness scale
Time frame: Baseline, 45 min, 1 week
Change in self-compassion
Time frame: Baseline, 45 min, 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja C Schmitt principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion, Acceptance and Distraction in people with Acute Pain, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual heat pain tolerance (time frame: Baseline, 45 min, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.