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Contemp Clin Trials. 2019 Nov 19;88:105898. doi: 10.1016/j.cct.2019.105898. [Epub ahead of print]

Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC).

Author information

1
Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, USA; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, USA. Electronic address: tonya.palermo@seattlechildrens.org.
2
Center for Child Health, Behavior & Development, Seattle Children's Research Institute, USA.
3
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
4
University of Texas Southwestern Medical School, Dallas, TX, USA.
5
University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.
6
Children's Hospital; of Pittsburgh, Pittsburgh, PA, USA.
7
Section of Pediatric Gastroenterology, Hepatology and Nutrition Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.
8
Nationwide Children's Hospital, Columbus, OH, USA.
9
Seattle Children's Hospital, Seattle, WA, USA.
10
Medical College of Wisconsin, Milwaukee, WI, USA.
11
Hospital for Sick Children, Toronto, ON, Canada.
12
University of California San Francisco, San Francisco, CA, USA.
13
Stanford University, Palo Alto, CA, USA.
14
Cedars-Sinai Medical Center, Los Angeles, CA, USA.
15
Children's Hospital of Philadelphia, Philadelphia, PA, USA.
16
Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.
17
Montreal Children's Hospital, McGill University, Montreal, QC, Canada.
18
School of Women's and Children's Health, Medicine, University of New South Wales and Sydney Children's Hospital Randwick Sydney, Australia.
19
University of Utah, Salt Lake City, UT, USA.
20
Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD, USA.
21
Massachusetts General Hospital for Children, Harvard Medical School, Boston, MA, USA.
22
Children's Hospital Los Angeles, Los Angeles, CA, USA.
23
The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
24
Washington University School of Medicine, Iowa City, IA, USA.
25
University of Iowa, Stead Family Children's Hospital, Iowa City, IA, USA.

Abstract

INTRODUCTION:

Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response.

METHODS:

This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization.

CONCLUSIONS:

This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.

KEYWORDS:

Acute recurrent pancreatitis; Children; Chronic pancreatitis; Cognitive-behavioral therapy; Internet intervention; Pain

PMID:
31756383
DOI:
10.1016/j.cct.2019.105898

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