Lindsay A Jibb1,2, Kathryn A Birnie3,4, Paul C Nathan3,5,6, Tanya N Beran7, Vanessa Hum3, J Charles Victor5,8, Jennifer N Stinson3,4,9. 1. School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada. 2. Evidence-to-Practice Program, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada. 3. Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Canada. 4. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada. 5. Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. 6. Division of Hematology/Oncology, Department of Pediatrics, Hospital for Sick Children, Toronto, Canada. 7. Cumming School of Medicine, University of Calgary, Calgary, Canada. 8. Institute for Clinical Evaluative Sciences, Toronto, Canada. 9. Department of Anesthesia and Pain Medicine, Hospital for Sick Children, Toronto, Canada.
Abstract
BACKGROUND:Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. METHODS: This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. RESULTS:Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. CONCLUSION: The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739.
RCT Entities:
BACKGROUND: Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing childpain and distress during subcutaneous port accesses. METHODS: This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of childpain and distress data, were used to address study aims. RESULTS: Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. CONCLUSION: The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739.
Authors: María Mar Lopez-Rodriguez; Alejandro Fernández-Millan; María Dolores Ruiz-Fernández; Iria Dobarrio-Sanz; Isabel María Fernández-Medina Journal: Int J Environ Res Public Health Date: 2020-05-19 Impact factor: 3.390