Cargando…
Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial
INTRODUCTION: Haemophilia is a bleeding disorder associated with significant pain, emotional distress, quality of life (QoL) impairment and considerable healthcare costs. Psychosocial health and effective pain management are considered essential end points for optimal haemophilia care, but there is...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5588949/ https://www.ncbi.nlm.nih.gov/pubmed/28871021 http://dx.doi.org/10.1136/bmjopen-2017-016973 |
_version_ | 1783262251663228928 |
---|---|
author | Pinto, Patrícia Ribeiro Paredes, Ana Cristina Costa, Patrício Carvalho, Manuela Lopes, Manuela Fernandes, Susana Pedras, Susana Almeida, Armando |
author_facet | Pinto, Patrícia Ribeiro Paredes, Ana Cristina Costa, Patrício Carvalho, Manuela Lopes, Manuela Fernandes, Susana Pedras, Susana Almeida, Armando |
author_sort | Pinto, Patrícia Ribeiro |
collection | PubMed |
description | INTRODUCTION: Haemophilia is a bleeding disorder associated with significant pain, emotional distress, quality of life (QoL) impairment and considerable healthcare costs. Psychosocial health and effective pain management are considered essential end points for optimal haemophilia care, but there is a significant gap in evidence-based treatments targeting these outcomes in people with haemophilia (PWH). Psychological interventions are cost-effective in promoting emotional well-being, QoL and pain control, although these have been scarcely used in haemophilia field. This investigation aims to evaluate the effectiveness of two psychological interventions for pain management, emotional regulation and promotion of QoL in PWH. METHODS AND ANALYSIS: This is a single-centre parallel randomised controlled trial conducted at a European Haemophilia Comprehensive Care Centre in Portugal, with five assessment points: baseline (T0), postintervention (T1), 3 (T2), 6 (T3) and 12 (T4) months follow-up. Eligible adult males, with moderate or severe haemophilia A or B will be randomised to experimental (EG) or control (CG) group. Intervention is either cognitive-behavioural therapy (EG1) or hypnosis (EG2), both consisting of four weekly sessions following standardised scripts delivered by trained psychologists. Randomisation will be computer generated, allocation concealment will be guaranteed and outcome assessors will be blind to EG/CG allocation. Main outcomes are pain and haemophilia-related QoL and secondary outcomes include clinical (clotting factor replacement consumption, joint bleeding episodes, analgesic intake) and psychological (pain coping strategies, anxiety, depression, illness perceptions) variables, functional assessment of the joints, inflammatory biomarkers (cytokines, high-sensitivity C reactive protein) and white blood cell count. ETHICS AND DISSEMINATION: This study was approved by the competent authorities and all procedures will comply with international ethical guidelines for clinical studies involving humans. Written informed consent will be obtained from all participants. The dissemination plan includes peer-reviewed scientific publications, conference participation and web and media coverage. TRIAL REGISTRATION NUMBER: NCT02870452. |
format | Online Article Text |
id | pubmed-5588949 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-55889492017-09-14 Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial Pinto, Patrícia Ribeiro Paredes, Ana Cristina Costa, Patrício Carvalho, Manuela Lopes, Manuela Fernandes, Susana Pedras, Susana Almeida, Armando BMJ Open Haematology (Incl Blood Transfusion) INTRODUCTION: Haemophilia is a bleeding disorder associated with significant pain, emotional distress, quality of life (QoL) impairment and considerable healthcare costs. Psychosocial health and effective pain management are considered essential end points for optimal haemophilia care, but there is a significant gap in evidence-based treatments targeting these outcomes in people with haemophilia (PWH). Psychological interventions are cost-effective in promoting emotional well-being, QoL and pain control, although these have been scarcely used in haemophilia field. This investigation aims to evaluate the effectiveness of two psychological interventions for pain management, emotional regulation and promotion of QoL in PWH. METHODS AND ANALYSIS: This is a single-centre parallel randomised controlled trial conducted at a European Haemophilia Comprehensive Care Centre in Portugal, with five assessment points: baseline (T0), postintervention (T1), 3 (T2), 6 (T3) and 12 (T4) months follow-up. Eligible adult males, with moderate or severe haemophilia A or B will be randomised to experimental (EG) or control (CG) group. Intervention is either cognitive-behavioural therapy (EG1) or hypnosis (EG2), both consisting of four weekly sessions following standardised scripts delivered by trained psychologists. Randomisation will be computer generated, allocation concealment will be guaranteed and outcome assessors will be blind to EG/CG allocation. Main outcomes are pain and haemophilia-related QoL and secondary outcomes include clinical (clotting factor replacement consumption, joint bleeding episodes, analgesic intake) and psychological (pain coping strategies, anxiety, depression, illness perceptions) variables, functional assessment of the joints, inflammatory biomarkers (cytokines, high-sensitivity C reactive protein) and white blood cell count. ETHICS AND DISSEMINATION: This study was approved by the competent authorities and all procedures will comply with international ethical guidelines for clinical studies involving humans. Written informed consent will be obtained from all participants. The dissemination plan includes peer-reviewed scientific publications, conference participation and web and media coverage. TRIAL REGISTRATION NUMBER: NCT02870452. BMJ Publishing Group 2017-09-03 /pmc/articles/PMC5588949/ /pubmed/28871021 http://dx.doi.org/10.1136/bmjopen-2017-016973 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Haematology (Incl Blood Transfusion) Pinto, Patrícia Ribeiro Paredes, Ana Cristina Costa, Patrício Carvalho, Manuela Lopes, Manuela Fernandes, Susana Pedras, Susana Almeida, Armando Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title | Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title_full | Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title_fullStr | Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title_full_unstemmed | Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title_short | Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial |
title_sort | effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult portuguese men with haemophilia (psy-haemopeq): study protocol for a single-centre prospective randomised controlled trial |
topic | Haematology (Incl Blood Transfusion) |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5588949/ https://www.ncbi.nlm.nih.gov/pubmed/28871021 http://dx.doi.org/10.1136/bmjopen-2017-016973 |
work_keys_str_mv | AT pintopatriciaribeiro effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT paredesanacristina effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT costapatricio effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT carvalhomanuela effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT lopesmanuela effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT fernandessusana effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT pedrassusana effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial AT almeidaarmando effectivenessoftwopsychologicalinterventionsforpainmanagementemotionalregulationandpromotionofqualityoflifeamongadultportuguesemenwithhaemophiliapsyhaemopeqstudyprotocolforasinglecentreprospectiverandomisedcontrolledtrial |