A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
Hants Williams, Susan G. Silva, Leigh Ann Simmons, Paula Jean Tanabe
Trials May 15, 2017 DOI: 10.1186/s13063-017-1948-x (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Sample size | 60 |
| Population | Adults with sickle cell disease and chronic pain at an outpatient comprehensive SCD center in the southeastern United States |
| Duration | Six sessions of 60 minutes each; questionnaires at baseline and weeks 1, 3, and 6 |
| Topics | Meditation |
| Citations | 6 |
| Registration | NCT02394587 |
| Key findings | The protocol outlines a randomized controlled trial to evaluate the acceptability, feasibility, and preliminary efficacy of a six-session telephonic group mindfulness-based intervention for adults with sickle cell disease and chronic pain, with pain catastrophizing as the main efficacy outcome. No results are reported. |
Abstract
Background: One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). METHODS/DESIGN: The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability.
Discussion: In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain.
Trial Registration: ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 13
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Mindfulness Interventions Annual Review of Psychology September 30, 2016
- How long does a mindfulness‐based stress reduction program need to be? A review of class contact hours and effect sizes for psychological distress Journal of Clinical Psychology March 23, 2009
- The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting Journal of Workplace Behavioral Health April 1, 2013
- Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids. Journal of Neuroscience March 16, 2016
and 8 more in the library