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

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 promi...

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Autores principales: Williams, Hants, Silva, Susan, Simmons, Leigh Ann, Tanabe, Paula
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5432983/
https://www.ncbi.nlm.nih.gov/pubmed/28506281
http://dx.doi.org/10.1186/s13063-017-1948-x
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author Williams, Hants
Silva, Susan
Simmons, Leigh Ann
Tanabe, Paula
author_facet Williams, Hants
Silva, Susan
Simmons, Leigh Ann
Tanabe, Paula
author_sort Williams, Hants
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1948-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-54329832017-05-17 A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial Williams, Hants Silva, Susan Simmons, Leigh Ann Tanabe, Paula Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1948-x) contains supplementary material, which is available to authorized users. BioMed Central 2017-05-15 /pmc/articles/PMC5432983/ /pubmed/28506281 http://dx.doi.org/10.1186/s13063-017-1948-x Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Williams, Hants
Silva, Susan
Simmons, Leigh Ann
Tanabe, Paula
A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title_full A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title_fullStr A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title_full_unstemmed A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title_short A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
title_sort telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5432983/
https://www.ncbi.nlm.nih.gov/pubmed/28506281
http://dx.doi.org/10.1186/s13063-017-1948-x
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