Meditation for Pain

NCT03495726 | Completed

• 1 other identifier: IRB00095434
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. All participants will be asked to complete a set of questionnaires

Conditions

Chronic Pain

Keywords

Contemplative; Applications; Well-being

Outcome Measures

Primary Outcomes (3)

• Change in Pain Catastrophizing Scale Score

  The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel. helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.

  Baseline, Week 3, Week 6, Week 14

• Change in Brief Pain Inventory

  The Brief Pain Inventory is a 9-item inventory that measures both pain severity and pain interference in daily functioning with 2 scales. Questions are answered on an 11-point Likert scale from 0 to 10 and scales are scored by obtaining the mean for two separate scales: pain severity and pain interference.

  Baseline, Week 3, Week 6, Week 14

• Change in Current Opioid Misuse Measure (COMM) Score

  The COMM is a 17-item questionnaire assessing the aberrant medication-related behaviors of patients with chronic pain. Participants indicate how often they have experienced specific aberrant medication-related behaviors in the past 30 days on a scale from 0 (never) to 4 (very often). Total scores range from 0 to 68 with higher scores indicating more problematic behaviors.

  Baseline, Week 3, Week 6, Week 14

Secondary Outcomes (6)

• Change in Physical Functioning Subscale (PF-10) Score

  Baseline, Week 3, Week 6, Week 14

• Change in Basel Assessment of Adherence Immunosuppression Scale Score

  Baseline, Week 3, Week 6, Week 14

• Change in Depression Anxiety and Stress Scale (DASS) Score

  Baseline, Week 3, Week 6, Week 14

• Change in Brief Coping with Problems Experienced (COPE) Inventory

  Baseline, Week 3, Week 6, Week 14

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Social Functioning - Short Form Score

  Baseline, Week 3, Week 6, Week 14

Study Arms (2)

Headspace app

EXPERIMENTAL

Participants randomized to use the mindfulness app for 6 weeks.

Behavioral: Headspace app

Waitlist control group

NO INTERVENTION

This group will receive treatment as usual for 6 weeks. After the completing the 6-week surveys, the waitlist group will receive a subscription to the Headspace app.

Interventions

Headspace app BEHAVIORAL

Headspace is a Contemplative Application (App) for Well-being (CAW). Participants will be provided initial instructions for downloading and using the Headspace app. The Headspace app includes guided meditations, articles and videos. Participants will be asked to engage in meditation practice for an average of 10 minutes a day during the 6-week training period.

Also known as: Contemplative Applications for Well-being

Headspace app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emory Healthcare patient

You may not qualify if:

• Non-english speaking patients
• Children, prisoners or other vulnerable populations

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Health

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Jennifer Mascaro, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 12, 2018
• Study Start: June 5, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-03

Locations

US (1)