Feasibility and Efficacy of a Mindfulness-enhanced Positive Affect Induction for Experimentally Induced Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pain Tolerance, assessed by duration of CPT
研究概览
简要总结
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
详细描述
The purpose of the study is to assess the following aims:
Aim 1: Examine the feasibility and acceptability of a mindfulness-enhanced positive affect induction (MPAI) for improving the experience of experimentally-induced pain.
Aim 2: Examine the efficacy of the MPAI in reducing pain intensity and increasing pain tolerance.
Aim 3: Examine change in self-efficacy in pain management from before and after using the MPAI.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •University of Colorado Students
- •Age 18-65
- •Fluent in written and spoken English
排除标准
- •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)
- •Food, caffeine, and nicotine are not to be had within 30 minutes of cold pressor test (nicotine patch not exclusionary due to stable/consistent state).
研究组 & 干预措施
Mindfulness-enhanced positive affect induction (MPAI)
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.
干预措施: Mindfulness-enhanced positive affect induction (Behavioral)
Breathing meditation (BM)
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.
干预措施: Breathing Meditation (Behavioral)
Natural Response (NR)
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.
结局指标
主要结局
Pain Tolerance, assessed by duration of CPT
时间窗: 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 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 Intensity, assessed by VAS
时间窗: Pain intensity will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
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 Unpleasantness, assessed by VAS
时间窗: Pain unpleasantness will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
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.
Acceptability of MPAI as a technique for reducing pain, assessed by six questions on satisfaction and usefulness of the MPAI
时间窗: Acceptability questions will be assessed immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
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.
Self-Efficacy in Pain Management assessed by change in Pain Beliefs Questionnaire (PBQ) total scores
时间窗: 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)
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
Feasibility beliefs of MPAI as implementable and efficacious for pain management, assessed by three PBQ items
时间窗: Feasibility measures (i.e., the PBQ) will be collected immediately after the intervention (i.e., the CPT) during the post-CPT survey set.
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.
次要结局
- 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)])
- 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)