Lisa Scharff1, Dawn A Marcus, Bruce J Masek. 1. Pain Treatment Service, Children's Hospital, Boston, Massachusetts 02115, USA. lisa.scharff@tch.harvard.edu
Abstract
OBJECTIVE: To evaluate the effectiveness of handwarming biofeedback (HWB) and stress management training in comparison to attention (handcooling, HCB) and wait-list control groups. Thermal biofeedback has been used in many pediatric migraine treatment studies and has demonstrated a consistent therapeutic effect. No published studies to date have compared this treatment modality with credible attention control using biofeedback technology. METHODS:Thirty-six children and adolescents (mean age: 12.8 years), as well as the mothers and fathers of these children enrolled in the study, were randomly assigned to the three groups. Thirty-four children completed treatment. Both treatment groups received four sessions of biofeedback training and a portable biofeedback device for home practice. Ratings of treatment credibility showed that the children rated the two treatments as equally credible. Assessment included anxiety and depression questionnaires for the children and both of their parents. RESULTS: Children who had been assigned to the HWB group were more likely to achieve clinical improvement in migraine after treatment than the children in the HCB group. Treatment gains were maintained up to 6 months after treatment. Home practice data reflected a general increase in temperature in the HWB group and a decrease in temperature for the HCB group. CONCLUSIONS: The results of this study confirm the findings of earlier pediatric migraine biofeedback treatment studies and also provide support for the specific effect of treatments including stress management and HWB. Future studies with larger sample sizes will aid in delineating the appropriateness of HCB as a control treatment.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of handwarming biofeedback (HWB) and stress management training in comparison to attention (handcooling, HCB) and wait-list control groups. Thermal biofeedback has been used in many pediatric migraine treatment studies and has demonstrated a consistent therapeutic effect. No published studies to date have compared this treatment modality with credible attention control using biofeedback technology. METHODS: Thirty-six children and adolescents (mean age: 12.8 years), as well as the mothers and fathers of these children enrolled in the study, were randomly assigned to the three groups. Thirty-four children completed treatment. Both treatment groups received four sessions of biofeedback training and a portable biofeedback device for home practice. Ratings of treatment credibility showed that the children rated the two treatments as equally credible. Assessment included anxiety and depression questionnaires for the children and both of their parents. RESULTS:Children who had been assigned to the HWB group were more likely to achieve clinical improvement in migraine after treatment than the children in the HCB group. Treatment gains were maintained up to 6 months after treatment. Home practice data reflected a general increase in temperature in the HWB group and a decrease in temperature for the HCB group. CONCLUSIONS: The results of this study confirm the findings of earlier pediatric migraine biofeedback treatment studies and also provide support for the specific effect of treatments including stress management and HWB. Future studies with larger sample sizes will aid in delineating the appropriateness of HCB as a control treatment.
Authors: Gianluca Castelnuovo; Emanuele M Giusti; Gian Mauro Manzoni; Donatella Saviola; Arianna Gatti; Samantha Gabrielli; Marco Lacerenza; Giada Pietrabissa; Roberto Cattivelli; Chiara A M Spatola; Stefania Corti; Margherita Novelli; Valentina Villa; Andrea Cottini; Carlo Lai; Francesco Pagnini; Lorys Castelli; Mario Tavola; Riccardo Torta; Marco Arreghini; Loredana Zanini; Amelia Brunani; Paolo Capodaglio; Guido E D'Aniello; Federica Scarpina; Andrea Brioschi; Lorenzo Priano; Alessandro Mauro; Giuseppe Riva; Claudia Repetto; Camillo Regalia; Enrico Molinari; Paolo Notaro; Stefano Paolucci; Giorgio Sandrini; Susan G Simpson; Brenda Wiederhold; Stefano Tamburin Journal: Front Psychol Date: 2016-02-19
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