Leigh Ann Simmons1, Hants Williams2, Susan Silva3, Francis Keefe4, Paula Tanabe5. 1. Duke University School of Nursing, Durham, North Carolina. Electronic address: leighann.simmons@duke.edu. 2. BioVirtua, San Francisco, California. 3. Duke University School of Nursing, Durham, North Carolina; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina. 4. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina. 5. Duke University School of Nursing, Durham, North Carolina.
Abstract
BACKGROUND: Few investigators have developed and tested nonpharmacological interventions for helping persons with sickle cell disease (SCD) manage persistent pain. AIMS: The purpose of this pilot study was to examine the feasibility and acceptability of a mindfulness-based intervention (MBI) in adults with SCD and chronic pain and to gather preliminary data on its efficacy. DESIGN: Data on feasibility and acceptability, including recruitment, retention, and attendance rates, were collected during a single-site, randomized control trial. Participants were randomly assigned to either a 6-session group telephonic MBI or a wait-listed control. Pain catastrophizing was assessed at baseline and at weeks 1, 3, and 6. SETTING: Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast. PARTICIPANTS/ SUBJECTS:Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being. METHODS:Seventy-eight adults were recruited; 18 (23%) declined to participate; 60 were randomly assigned to either the MBI (N = 40) or control (N = 20). Of those, 14 (35%) from the MBI and 12 (60%) from the control group withdrew immediately after random allocation, resulting in 34 evaluable cases (MBI: N = 26; control: N = 8). RESULTS: Among the 26 assigned to MBI, the median number of sessions attended per person was 4; 7 (27%) attended all six sessions. Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content. Reductions in pain catastrophizing outcomes were identified after intervention. CONCLUSIONS: An MBI is feasible and acceptable for persons with SCD experiencing chronic pain. A larger randomized controlled trial to establish MBI efficacy on pain and related outcomes for SCD will provide nonpharmacologic, behavioral pain management options for nurses and other clinicians caring for persons with SCD and chronic pain.
RCT Entities:
BACKGROUND: Few investigators have developed and tested nonpharmacological interventions for helping persons with sickle cell disease (SCD) manage persistent pain. AIMS: The purpose of this pilot study was to examine the feasibility and acceptability of a mindfulness-based intervention (MBI) in adults with SCD and chronic pain and to gather preliminary data on its efficacy. DESIGN: Data on feasibility and acceptability, including recruitment, retention, and attendance rates, were collected during a single-site, randomized control trial. Participants were randomly assigned to either a 6-session group telephonic MBI or a wait-listed control. Pain catastrophizing was assessed at baseline and at weeks 1, 3, and 6. SETTING:Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast. PARTICIPANTS/ SUBJECTS: Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being. METHODS: Seventy-eight adults were recruited; 18 (23%) declined to participate; 60 were randomly assigned to either the MBI (N = 40) or control (N = 20). Of those, 14 (35%) from the MBI and 12 (60%) from the control group withdrew immediately after random allocation, resulting in 34 evaluable cases (MBI: N = 26; control: N = 8). RESULTS: Among the 26 assigned to MBI, the median number of sessions attended per person was 4; 7 (27%) attended all six sessions. Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content. Reductions in pain catastrophizing outcomes were identified after intervention. CONCLUSIONS: An MBI is feasible and acceptable for persons with SCD experiencing chronic pain. A larger randomized controlled trial to establish MBI efficacy on pain and related outcomes for SCD will provide nonpharmacologic, behavioral pain management options for nurses and other clinicians caring for persons with SCD and chronic pain.
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