Therapeutic Strategies During Exposure to Pain in an Experimental Design

NCT03146832 | Completed

• 1 other identifier: 2016-33v
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Pain tolerance

  Determined by the temperature at which the participant stopped the heat stimulus

  5 minutes prior and 5 minutes after three exposure practice trials

Secondary Outcomes (6)

• Pain intensity

  5 minutes prior and 5 minutes after three exposure practice trials

• Pain quality

  5 minutes prior and 5 minutes after three exposure practice trials

• Pain Catastrophizing Scale (PCS)

  1-week prior and 10 minutes after three exposure practice trials

• Pain Anxiety Symptom Scale (PASS)

  1-week prior and 10 minutes after three exposure practice trials

• Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)

  1-week prior and 10 minutes after three exposure practice trials

Study Arms (3)

Habituation

EXPERIMENTAL

The habituation instruction focuses on changes of the initial physical fear-responses during exposure sessions. It is explained that the level of anxiety will gradually decrease, or habituate, each time someone faces a feared situation. Participants are then instructed to observe their own level of fear during the three practice trials with the thermode. Together with the experimenter, participants have to indicate their level of arousal on an 11-point scale (0= neutral, 10 = very high) in-between and after the three practice trials. After the practice trial, participants are instructed to reconsider their own development of physical responses. Participants are encouraged to remember the development of their level of arousal during the test trail with the thermode.

Behavioral: Exposure therapy (according to habituation approach)

Expectation Violation

EXPERIMENTAL

The expectation violation instruction focuses on the verification of negative expectancies during exposures sessions. It is explained that exposure exercises help to create own experiences which allow to directly test negative predicted outcomes. Together with the experimenter, participants are then encouraged to formulate concrete concerns in regard to the practice trail with the thermode. Before the practice trails, participants have to indicate the likelihood of their concerns on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are instructed to evaluate their own concerns by some guided questions (e.g. "What did you learn?"). Participants are encouraged to keep their own experience in mind during the test trail with the thermode.

Behavioral: Exposure therapy (according to inhibitory learning approach)

Control

NO INTERVENTION

Participants in the control group are not provided with information about exposure therapy. Instead, participants listen to a newspaper article which reports on the daily work in a botanical garden. Together with the experimenter, participants are then asked to name the most interesting aspect in the article. Before the practice trails, participants have to rate how likely it is that they would further inform themselves about botanical gardens on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are provided with some further questions about the newspaper article (e.g. "Did you find the newspaper article interesting?"). This cognitive exercise does not cover any pain-related topics and, therefore, does not serve as a distraction instruction.

Interventions

Exposure therapy (according to habituation approach) BEHAVIORAL

Exposure instruction focuses on fear reduction during exposure sessions

Habituation

Exposure therapy (according to inhibitory learning approach) BEHAVIORAL

Exposure instruction focuses on expectation violation during exposure sessions

Expectation Violation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female gender
• sufficient knowledge of German language

You may not qualify if:

• chronic and acute pain conditions
• Raynaud's disease
• high blood pressure
• neuropathy, coronary diseases
• diabetes, current alcohol
• drug or pain-medication (last 24hours)

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Julia Anna Glombiewski, Phd

  Department of Clinical Psychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not aware which experimental condition they were allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Licensed Psychologist, Principal Investigator

Model Details: participants are assigned to one of three experimental groups in parallel for the duration of the study

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 10, 2017
• Study Start: April 1, 2017
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)