Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data
Introduction Pain is a multidimensional experience that varies among individuals and has a significant impact on their health. A biopsychosocial approach is recommended for effective pain management; however, health professionals’ education is weak on this issue. Patient involvement is a promising d...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/1/e078670.full |
| _version_ | 1797295754930290688 |
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| author | Francesca Rossi Roberto D'Amico Alice Serafini Luca Ghirotto Matías Eduardo Díaz Crescitelli Maria Grazia Rossi Sara Alberti Erika Borellini Annamaria Contini Simone Cernesi Paola Ferri Davide Fornaciari Linda Giugni Fausta Lui Riccardo Cuoghi Costantini Valentino Santori Maria Stella Padula |
| author_facet | Francesca Rossi Roberto D'Amico Alice Serafini Luca Ghirotto Matías Eduardo Díaz Crescitelli Maria Grazia Rossi Sara Alberti Erika Borellini Annamaria Contini Simone Cernesi Paola Ferri Davide Fornaciari Linda Giugni Fausta Lui Riccardo Cuoghi Costantini Valentino Santori Maria Stella Padula |
| author_sort | Francesca Rossi |
| collection | DOAJ |
| description | Introduction Pain is a multidimensional experience that varies among individuals and has a significant impact on their health. A biopsychosocial approach is recommended for effective pain management; however, health professionals’ education is weak on this issue. Patient involvement is a promising didactic methodology in developing a more holistic perspective, however there is a lack of reliable evidence on this topic. The aim of the present study is to evaluate the effectiveness of patient involvement in pain education in undergraduate medicine and nursing students.Methods and analysis An open-label randomised controlled trial including qualitative data will be conducted. After an introductory lesson, each student will be randomly assigned to the intervention group, which includes an educational session conducted by a patient–partner along with an educator, or to the control group in which the session is exclusively conducted by an educator. Both sessions will be carried out according to the Case-Based Learning approach. Primary outcomes will be students’ knowledge, attitudes, opinions and beliefs about pain management, whereas the secondary outcome will be students’ satisfaction. The Pain Knowledge and Attitudes (PAK) and Chronic Pain Myth Scale (CPMS) will be administered preintervention and postintervention to measure primary outcomes. Students’ satisfaction will be measured by a questionnaire at the end of the session. Two focus groups will be conducted to evaluate non-quantifiable aspects of learning.Ethics and dissemination The protocol of this study was approved by the independent Area Vasta Emilia Nord ethics committee.Adherence to The Declaration of Helsinki and Good Clinical Practice will ensure that the rights, safety and well-being of the participants in the study are safeguarded, as well as data reliability. The results will be disseminated through scientific publications and used to improve the educational offer. A version of the anonymised data set will be released for public access.Trial registration Trial was not registered on ClinicalTrials.gov as the interventions being compared only concern educational programmes and the outcomes considered do not refer to any clinical dimension. |
| first_indexed | 2024-03-07T21:52:32Z |
| format | Article |
| id | doaj.art-9beae756d9a54bb087d1c036d45d35a8 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-07T21:52:32Z |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-9beae756d9a54bb087d1c036d45d35a82024-02-25T05:10:08ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-078670Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative dataFrancesca Rossi0Roberto D'Amico1Alice Serafini2Luca Ghirotto3Matías Eduardo Díaz Crescitelli4Maria Grazia Rossi5Sara Alberti6Erika Borellini7Annamaria Contini8Simone Cernesi9Paola Ferri10Davide Fornaciari11Linda Giugni12Fausta Lui13Riccardo Cuoghi Costantini14Valentino Santori15Maria Stella Padula16Laboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyDepartment of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLocal Health Authority of Modena (Ausl), Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyDepartment of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, ItalyUnit of Methodological and Statistical Support to Clinical Research, Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena, Modena, ItalyLaboratorio EduCare, University of Modena and Reggio Emilia, Modena, ItalyIntroduction Pain is a multidimensional experience that varies among individuals and has a significant impact on their health. A biopsychosocial approach is recommended for effective pain management; however, health professionals’ education is weak on this issue. Patient involvement is a promising didactic methodology in developing a more holistic perspective, however there is a lack of reliable evidence on this topic. The aim of the present study is to evaluate the effectiveness of patient involvement in pain education in undergraduate medicine and nursing students.Methods and analysis An open-label randomised controlled trial including qualitative data will be conducted. After an introductory lesson, each student will be randomly assigned to the intervention group, which includes an educational session conducted by a patient–partner along with an educator, or to the control group in which the session is exclusively conducted by an educator. Both sessions will be carried out according to the Case-Based Learning approach. Primary outcomes will be students’ knowledge, attitudes, opinions and beliefs about pain management, whereas the secondary outcome will be students’ satisfaction. The Pain Knowledge and Attitudes (PAK) and Chronic Pain Myth Scale (CPMS) will be administered preintervention and postintervention to measure primary outcomes. Students’ satisfaction will be measured by a questionnaire at the end of the session. Two focus groups will be conducted to evaluate non-quantifiable aspects of learning.Ethics and dissemination The protocol of this study was approved by the independent Area Vasta Emilia Nord ethics committee.Adherence to The Declaration of Helsinki and Good Clinical Practice will ensure that the rights, safety and well-being of the participants in the study are safeguarded, as well as data reliability. The results will be disseminated through scientific publications and used to improve the educational offer. A version of the anonymised data set will be released for public access.Trial registration Trial was not registered on ClinicalTrials.gov as the interventions being compared only concern educational programmes and the outcomes considered do not refer to any clinical dimension.https://bmjopen.bmj.com/content/14/1/e078670.full |
| spellingShingle | Francesca Rossi Roberto D'Amico Alice Serafini Luca Ghirotto Matías Eduardo Díaz Crescitelli Maria Grazia Rossi Sara Alberti Erika Borellini Annamaria Contini Simone Cernesi Paola Ferri Davide Fornaciari Linda Giugni Fausta Lui Riccardo Cuoghi Costantini Valentino Santori Maria Stella Padula Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data BMJ Open |
| title | Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data |
| title_full | Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data |
| title_fullStr | Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data |
| title_full_unstemmed | Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data |
| title_short | Effectiveness of patients’ involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data |
| title_sort | effectiveness of patients involvement in a medical and nursing pain education programme a protocol for an open label randomised controlled trial including qualitative data |
| url | https://bmjopen.bmj.com/content/14/1/e078670.full |
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