Study of Affect Induction for Lab Induced Pain in Healthy Undergraduates

NCT05619419 | Completed

• 1 other identifier: 20-0030
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test if a mindfulness-enhanced positive affect induction (MPAI) works well to reduce pain intensity and pain unpleasantness from a cold water pain test in undergraduate college students who do not endorse ongoing medical or mental health diagnoses. The main questions it aims to answer are:

• Is the MPAI a feasible and acceptable psychological technique for managing brief pain?
• Does the MPAI work well to reduce pain intensity and unpleasantness from experimentally induced brief pain, compared to those using a breathing meditation or those instructed to respond naturally.
• Does using the MPAI work well to improve confidence in self-managing brief pain? Participants will be asked to complete questionnaires about their sleep, pain beliefs, and emotions after consenting to participate and at the end of the study session. They will then be randomized to either:
• Use the MPAI for managing pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius).
• Use a breathing meditation for managing pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius).
• Respond naturally to pain induced by a cold water test (placing their hand in a container of cold water kept at approximately 5 degrees Celsius). Researchers will compare the MPAI group to the breathing meditation and natural response groups to see if the MPAI group reports less pain from the cold water test and

Conditions

Meditation; Pain; Mindfulness; Affect; Emotion Regulation

Keywords

Mindfulness-enhanced; Positive affect; Meditation; Pain self-management; Behavioral; Mindfulness; Mindfulness-enhanced positive affect induction (MPAI); Experimentally induced pain; Cold pressor test (CPT); Breathing Meditation (BM); Natural Response (NR)

Outcome Measures

Primary Outcomes (6)

• Pain Tolerance, assessed by duration of CPT

  Pain tolerance will be assessed via the amount of time (i.e., number of seconds) until participants remove their hand from the cold water during the cold pressor test (CPT). CPT duration will be timed via a stopwatch and will begin when the participant's hand is submerged in the cold water up to the wrist and will stop immediately when the hand is removed. More time in the water will be indicative of greater pain tolerance. Water temperature will be maintained at 5 degrees Celsius to optimize potential for pain intensity and tolerance during the CPT measures. Longer duration of the CPT will indicate higher pain tolerance.

  Pain tolerance, assessed by duration of the CPT, will be recorded immediately after the intervention (i.e., the CPT), during the post-CPT survey set

• Pain Intensity, assessed by VAS

  Pain intensity will be assessed via two items: "Please rate your peak pain intensity experienced during the cold water test" and "Please rate your average pain intensity experienced during the cold water test". Each item response will be rated on a 0-100 visual analog scale (VAS). "0" will indicate no pain intensity and "100" will indicate intolerable pain intensity, with higher scores indicating higher pain intensity.

  Pain intensity will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.

• Pain Unpleasantness, assessed by VAS

  Pain unpleasantness will be assessed via two items: "Please rate your peak pain unpleasantness experienced during the cold water test (e.g., how bothersome you found the pain from the cold water test)" and "Please rate your average pain unpleasantness experienced during the cold water test (e.g., how bothersome you found the pain from the cold water test)". Each item response will be rated on a 0-100 visual analog scale (VAS). "0" will indicate no pain unpleasantness and "100" will indicate intolerable pain unpleasantness, with higher scores indicating higher pain unpleasantness.

  Pain unpleasantness will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.

• Feasibility beliefs of MPAI as implementable and efficacious for pain management, assessed by three PBQ items

  Feasibility beliefs of MPAI in pain management will be assessed via three items from the Pain Beliefs Questionnaire (PBQ): "Would you be able to perform the coping strategy while in pain?", 2) "How well will you be able to focus your attention on the coping strategy while in pain?", 3) "How confident are you that you will be able to use the coping strategy to reduce your pain while in pain?". Item responses will be given on a 0-6 seven-point Likert scale with anchors varying by the item (e.g. Not at all Confident/Very Confident, Not at all Well/Very well, and Very Uncertain/Very Certain). Means and percentages will be calculated. Good feasibility with PBQ items will be considered by high mean percentage ratings (≥80%) for each item, with higher mean percentages will indicating greater feasibility (see Outcome 6 below for detail on PBQ). Although the PBQ will be assessed at multiple time points, feasibility analyses will only include items assessed immediately after the intervention.

  Feasibility measures (i.e., the PBQ) will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.

• Acceptability of MPAI as a technique for reducing pain, assessed by six questions on satisfaction and usefulness of the MPAI

  Acceptability will be assessed via the following items: "How acceptable did you find the coping strategy to be?", "How satisfied are you with the coping strategy?", "How useful was the coping strategy?", "Was the coping strategy easy to understand?", "Was the coping strategy easy to use?", "How likely are you to use the coping strategy you learned today?". Item responses will be given on a 0-6 seven-point Likert scale with anchors varying by the item (e.g. Not at all Acceptable/Very Acceptable, Not at all Satisfied/Very Satisfied, Not at all Useful/Very Useful, Extremely Difficult to Understand/Very Easy to Understand, Extremely Difficult to Use/Very Easy to Use, and Not at all Likely/Highly Likely). Means, standard deviations, and percentages of PBQ items will be calculated. Good acceptability will be considered by high mean percentage ratings (≥80%) for each item, with higher mean percentages indicating greater acceptability.

  Acceptability questions will be assessed immediately after the intervention (i.e., the CPT) during the post-CPT survey set.

• Self-Efficacy in Pain Management assessed by change in Pain Beliefs Questionnaire (PBQ) total scores

  Self-efficacy in pain management will be assessed via the Pain Beliefs Questionnaire (PBQ). The PBQ is a nine-item instrument assessing beliefs in ability to manage pain, as well as ability to learn and utilize a pain self-management technique, with high internal consistency (Chronbach's alpha = 0.89). Example items include: "The degree of pain I experience is mostly up to me" and "How well will you be able to focus your attention on the coping strategy while in pain?". Item responses are given on a 1-7 seven-point scale with anchors such as True/False, Agree/Disagree, Difficult/Easy, Very Little Control/Complete Control, Very Uncertain/Very Certain, Not at all Well/Very well, and Not at all Confident/Very Confident. Total PBQ scores are calculated as the mean of all nine items, with higher scores representing higher levels of self-efficacy in pain management

  Self-efficacy in pain management, assessed by change in PBQ total scores will be assessed during the baseline survey set and the post-CPT survey set (i.e., immediately after the intervention)

Secondary Outcomes (2)

• Present-Moment Affect, assessed by affect ratings

  Present-moment affect will be collected during baseline, before the CPT (after condition practice), immediately following the CPT

• Positive Affect Manipulation Check

  The positive affect manipulation check measure will be assessed pre-intervention [i.e., immediately after practice of the respective meditation, immediately before using the respective meditation during the cold pressor task (CPT)]

Other Outcomes (8)

• Demographics

  Demographics will be assessed during the baseline survey set

• Positive and Negative Affect (past 7 days), assessed by PANAS

  The PANAS will be assessed during the baseline survey set

• Pain Catastrophizing, assessed by the PCS

  The PCS will be assessed during the baseline survey set

Study Arms (3)

Mindfulness-enhanced positive affect induction (MPAI)

EXPERIMENTAL

The MPAI is a method of bringing mindful (nonjudgmental) awareness to positive emotions, thoughts, and memories and is not expected to result in adverse experiences. It includes beginning with mindful awareness of the breath (i.e., meditation focusing on the breath) to draw attention away from negative aspects of pain. With continued awareness of the breath, smiling and gentle laughter are begun in order to initiate positive affect. With continued smiling and laughter, participants then imagine the smiles and laughter of those they are fond of, to allow a positive affect state to build upon itself and trigger state dependent positive memories, thoughts, emotions (e.g., gratitude) and self-efficacy of pain management.

Behavioral: Mindfulness-enhanced positive affect induction

Breathing meditation (BM)

ACTIVE COMPARATOR

Breathing meditation is a method of bringing mindful (nonjudgmental) awareness to various aspects of the breath and is aimed toward attaining a neutral state of affect and is not expected to result in adverse experiences. It involves bringing present-moment focused, nonjudgmental awareness to aspects breathing, such as sensations of airflow with each inhalation and exhalation, as well noticing the rise and expansion of the chest and belly with each inhalation. The use of breathing mediation will serve as a comparison task for the MPAI.

Behavioral: Breathing Meditation

Natural Response (NR)

NO INTERVENTION

Participants instructed to respond naturally to the cold pressor test will be instructed to not attempt to modify or control their experience (e.g., via distraction or use of meditation). Natural response will serve as a control comparator for the MPAI and is not expected to result in adverse experiences.

Interventions

Mindfulness-enhanced positive affect induction BEHAVIORAL

Participants will receive brief psychoeducation about biopsychosocial pain management and practice with the MPAI via guided audio recording. They will then listen to the audio recording a final time before beginning the cold pressor test for experimental pain induction. They will be instructed to continue using the MPAI to manage pain during the cold pressor test.

Also known as: MPAI

Mindfulness-enhanced positive affect induction (MPAI)

Breathing Meditation BEHAVIORAL

Participants will receive brief psychoeducation about biopsychosocial pain management and practice with the BM via guided audio recording. They will then listen to the audio recording a final time before beginning the cold pressor test for experimental pain induction. They will be instructed to continue using the BM to manage pain during the cold pressor test.

Also known as: BM

Breathing meditation (BM)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University of Colorado Students
• Age 18-65
• Fluent in written and spoken English

You may not qualify if:

• Presence of an untreated mood or psychiatric disorder
• Presence of a current chronic pain condition
• Presence or history of Reynaud's syndrome, peripheral neuropathy, or unstable heart condition (including myocardial infarction, abnormal heart rhythms, or hypertension)
• Current use of prescription pain medication, high-dose anti-psychotics, selective serotonin re-uptake inhibitors (SSRIs), benzodiazepines, or gabapentin
• Day-of over the counter pain medication use
• Marijuana, Cannabidiol (CBD), or psilocybin use within three days of study participation (recency of use assessed via self-report)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Related Publications (9)

• Tonelli ME, Wachholtz AB. Meditation-based treatment yielding immediate relief for meditation-naive migraineurs. Pain Manag Nurs. 2014 Mar;15(1):36-40. doi: 10.1016/j.pmn.2012.04.002. Epub 2012 Jun 20.

  PMID: 24602422 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014.

  PMID: 24851056 BACKGROUND

• Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7. doi: 10.1016/j.jpain.2004.03.004.

  PMID: 15162346 BACKGROUND

• Rokke PD, al Absi M, Lall R, Oswald K. When does a choice of coping strategies help? The interaction of choice and locus of control. J Behav Med. 1991 Oct;14(5):491-504. doi: 10.1007/BF00845106.

  PMID: 1744911 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• 1. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment. 2009;7(4):524-532. doi:10.1037/1040-3590.7.4.524

  BACKGROUND

• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.

  PMID: 22250775 BACKGROUND

• Curran S, Andrykowski M, Studts J. Short Form of the Profile of Mood States (POMS-SF): Psychometric information. Psychological Assessment. Published online March 1995. Accessed January 11, 2020. https://www.academia.edu/1578109/Short_Form_of_the_Profile_of_Mood_States_POMS-SF_Psychometric_information

  BACKGROUND

MeSH Terms

Conditions

Pain; Emotional Regulation; Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior

Study Officials

• Dustin S Goerlitz, MA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Amy Wachholtz, PhD

  University of Colorado, Denver

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistant will be aware of participant randomization, as necessary for providing the correct study instructions and procedures (e.g., pain psycho-education and meditation audio recording). Participants will not be masked, as they will receive specific instructions on and audio recorded meditation practice based on their group.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of three groups: mindfulness-enhanced positive affect induction (MPAI), breathing meditation (BM), or natural response (NR). Pain will be induced via a cold pressor test (CPT), as the CPT can closely resemble tonic increasing pain similar to that of pain flares. Participants will be instructed to either respond naturally, use the MPAI, or breathing meditation for managing pain during the CPT. Relevant pain related outcomes and covariates will be assessed via baseline and post-CPT questionnaires. The MPAI is the primary intervention being examined, with the BM and NR groups as active comparison and control groups respectively.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 16, 2022
• Study Start: March 14, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)