Meditation for Pain

NCT ID: NCT03495726

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2020-03-03

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

Detailed Description

Chronic pain affects an estimated 11.2% of the US population, costs the United States approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. Understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. However, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (Apps) for Well-being (CAWs). The proposed study will examine the use and impact of a meditation apps in the context of pain. Participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. To assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Headspace app

Participants randomized to use the mindfulness app for 6 weeks.

Group Type: EXPERIMENTAL

Headspace app

Intervention Type: 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.

Waitlist control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Headspace app

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Contemplative Applications for Well-being

Eligibility Criteria

Inclusion Criteria

• Emory Healthcare patient

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mascaro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Mascaro, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00095434

Identifier Type: -

Identifier Source: org_study_id