The Development and Evaluation of Pain Neuroscience Education in Children

NCT ID: NCT05943587

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-05-16

Brief Summary

The International Association for the Study of Pain and The International Classification of Diseases (ICD) 11 define chronic pain as pain lasting more than 3 months, regardless of the cause. For children and adolescents, chronic pain is an extremely terrible and suffering problem. Periods of persistent pain negatively affect the child's participation in school and recreational activities, leading to academic problems and social exclusion. Moreover, children are at increased risk of experiencing chronic pain problems in adulthood. Because of these difficulties children with chronic pain should be treated as soon as possible. Pain Neuroscience Education (PNE) is an educational approach used in chronic pain rehabilitation. The purpose of PNE is to change individual's perception of pain. The most fundamental and crucial aspect of PNE is educating patients about the underlying causes of their pain. The primary purpose of the project is to conduct a modified Delphi survey to obtain and synthesize expert opinions on PNE materials. The second aim of this study is to investigate the effect of PNE on pain, quality of life and participation in children with chronic pain and compare it with the standard treatment program.

Detailed Description

Chronic pain is not directly cause death but it is a major source of disability and suffering. Because of the enormous medical, economic, and social burden of chronic pain worldwide better understanding of pain biology has become a critical topic in order to develop targeted, novel, safe, and effective treatments. Pain Neuroscience Education (PNE) is a multidisciplinary educational method used by physiotherapists worldwide in chronic pain rehabilitation. The goal of PNE is to alter a person's perception of pain. PNE aims to correct patient misconceptions about pain physiology. As a result, pain education can help to reduce levels of fear of pain, fear of movement, pain catastrophizing thoughts, and passive coping strategies (for example, the use of painkillers or massage treatments). Currently, only a few research have investigated the benefits of PNE in children. The majority of studies have focused on pain management education programs rather than explaining the neurology of pain. The combined effects of PNE and physiotherapy have not been studied in children. But adult studies are demonstrated that PNE and physiotherapy are effective. According to studies, PNE has been linked to promising results in the treatment of chronic pain and functional impairment in adults. James et al. concluded that PNE reduced pain, disability, pain catastrophization, and kinesiophobia in the short and medium term, based on a systematic evaluation of 12 randomized controlled studies assessing the effect of PNE in individuals with chronic musculoskeletal pain. Currently, no study has been conducted in investigators country that has adapted PNE for children and evaluated the consequences of PNE use. The primary aim of the research is to perform a modified Delphi survey to obtain and synthesize expert opinions on culturally appropriate PNE materials for children in terms of content, relevance of information, clarity and intelligibility of information, and visual qualities of the materials. The second aim of the research is to investigate the impacts of culturally tailored PNE on pain symptoms (pain severity, pain awareness, fear of pain, catastrophizing pain, dealing with pain), quality of life, and involvement in children with chronic pain, as well as to compare it to a normal education program.

Conditions

Chronic Pain; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chronic pain group

30-45 minute individual sessions of culture-sensitive PNE4kids training will be applied.

Group Type: EXPERIMENTAL

culture-sensitive PNE4kids

Intervention Type: OTHER

Culturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation.

Control Group

30-45 minute individual sessions of standard education training will be applied.

Group Type: ACTIVE_COMPARATOR

standard education

Intervention Type: OTHER

Standard education used by physiotherapists worldwide in chronic pain rehabilitation.

Interventions

culture-sensitive PNE4kids

Culturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation.

Intervention Type: OTHER

standard education

Standard education used by physiotherapists worldwide in chronic pain rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 8 years and 12 years;
• Diagnosed with chronic pain (at least three months of pain and a pain frequency of three or more days per week)
• Those who do not take analgesics 48 hours prior to study evaluations.

Exclusion Criteria

• Patients with unmanageable psychological disorders (e.g., attention deficit hyperactivity disorder, autistic spectrum disorder, schizophrenia, bipolar disorder, major depressive disorder) would be excluded from the study.

Patients who started a new treatment during the trial or 6 weeks before to the study for chronic pain.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Ozgun Kaya Kara

Assoc. Prof. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozgun Kaya Kara, Assoc. Prof.

Role: STUDY_DIRECTOR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

ishak Isık, Prof. Dr.

Role: CONTACT

etik.kurul.07@gmail.com

02422494400

Ishak Isık, Prof

Role: CONTACT

etik.kurul.07@gmail.com

02422494400

Facility Contacts

Ozgun KAYA KARA, Assoc. Prof.

Role: primary

ozgunkara@akdeniz.edu.tr

References

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Reference Type: BACKGROUND

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Other Identifiers

2022-127

Identifier Type: -

Identifier Source: org_study_id