NCT03647683

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

August 1, 2018

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain intensity

    Baseline, 45 min, 1 week

  • Change in pain unpleasantness scale

    Baseline, 45 min, 1 week

  • Change in self-compassion

    Baseline, 45 min, 1 week

Study Arms (3)

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.

Other: Self-CompassionOther: 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.

Other: AcceptanceOther: 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.

Other: DistractionOther: Heat pain

Interventions

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.

Self-Compassion

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.

Acceptance

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.

Distraction

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

AcceptanceDistractionSelf-Compassion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sufficient german language knowledge
  • at least 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps-University of Marburg

Marburg, Hesse, 35032, Germany

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone LengtheningOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Anja C Schmitt

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 27, 2018

Study Start

April 15, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations