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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial

Authors: Hants Williams, Susan Silva, Leigh Ann Simmons, Paula Tanabe

Published in: Trials | Issue 1/2017

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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.
Appendix
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Metadata
Title
A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
Authors
Hants Williams
Susan Silva
Leigh Ann Simmons
Paula Tanabe
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1948-x

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