The Development and Evaluation of Pain Neuroscience Education in Children

July 5, 2023 updated by: Ozgun Kaya Kara, Akdeniz University

The Development and Evaluation of Culturally Sensitive Pain Neuroscience Education in Children With Chronic Pain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University
        • Contact:
        • Sub-Investigator:
          • ceren Gursen, Assoc.Prof
        • Sub-Investigator:
          • Kelly Ickmans, Assoc.Prof
        • Sub-Investigator:
          • Emma Rheel, PT
        • Principal Investigator:
          • Ozgun Kaya Kara, Assoc.Prof
        • Sub-Investigator:
          • Koray Kara, Assoc.Prof
        • Sub-Investigator:
          • Gultekin Kutluk, MD
        • Sub-Investigator:
          • Yaprak Cetin, Assoc. Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic pain group
30-45 minute individual sessions of culture-sensitive PNE4kids training will be applied.
Other: culture-sensitive PNE4kids
Culturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation.
Active Comparator: Control Group
30-45 minute individual sessions of standard education training will be applied.
Other: standard education
Standard education used by physiotherapists worldwide in chronic pain rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Faces Scale
Time Frame: change from baseline to end of the 1 week and 4 weeks
It is a valid and reliable scale preferred by children and their families to evaluate the severity of pain. It consists of 6 facial expressions that symbolize the severity of pain. These show the stages of increased pain from a smiling face (0 points) to a very sad and crying face (10 points). The meaning of each facial expression is carefully explained to the child. Children rate pain intensity according to face shapes.It consists of 6 facial expressions that symbolize the severity of the pain. It is scored between 0-10. Increasing scores indicate more pain.
change from baseline to end of the 1 week and 4 weeks
Pain Vigilance and Awareness Questionnaire Child & Adult Version
Time Frame: change from baseline to end of the 1 week and 4 weeks
Pain Vigilance and Awareness Questionnaire Child evaluates children's attention to pain. There are 14 items on the scale. A 0-5 likert scale is used for scoring. It has a rating of 0 (never) to 5 (always) (always). The total score is calculated by multiplying the individual item scores. Pain Vigilance and Awareness Questionnaire-Adult uses 16 items to test adults' attention and pain awareness. It has ten items for paying attention and six ones for being aware. A 0-5 likert scale is used for scoring. 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always, and 5 = always. The scale's eighth and sixteenth items are scored in reverse order. The scaled total score ranges from 0 to 80. Higher ratings suggest that you are more conscious of your pain.Items are rated on a 6-point scale, ranging from 0 (never) to 5 (always). The 8th and 16th items of the scale are reverse scored. The scale total score is obtained between 0-80. Higher scores indicate greater awareness of pain.
change from baseline to end of the 1 week and 4 weeks
Fear of Pain Questionnaire for Children/Parents
Time Frame: change from baseline to end of the 1 week and 4 weeks
The Fear of Pain Questionnaire for Children-Short Form is a 10-item version of the 24-item Fear of Pain Questionnaire for Children. It uses children's self-reports to assess pain-related fears (4 items) and avoidance behaviours (6 items). A 0-4 Likert scale is used for scoring. A score of 0 indicates strong disagreement, while a score of 5 indicates strong agreement.Items are summed to derive a total score (with between 0-40) . Higher scores indicate higher pain-related fear and avoidance behaviors.
change from baseline to end of the 1 week and 4 weeks
Pain Catastrophizing Scale- Child
Time Frame: change from baseline to end of the 1 week and 4 weeks
Crombez et al. created the Pain Catastrophizing Scale-Child, an adaptation of the Pain Catastrophizing Scale for children. Catastrophizing behaviours is evaluated with 13 items: rumination (4 items), magnification (3 items), and helplessness (6 items). The scoring is done on a 0-4 point Likert scale. It is evaluated on a scale of 0 (not at all) to 4 (very extremely).Items are summed to derive a total score (with between 0-52), with higher scores indicating more pain catastrophizing.
change from baseline to end of the 1 week and 4 weeks
Functional Disability Inventory
Time Frame: change from baseline to end of the 1 week and 4 weeks
Walker and Greene developed the Functional Disability Inventory to assess challenges faced by school-age children and adolescents in executing activities of daily living from the child's perspective. There are 15 items in Functional Disability Inventory. Each item asks about how many physical challenges or obstacles the youngster has experienced while executing the activity in the previous few days. The scoring is done on a 0-4 point Likert scale. It is ranked between 0 (no problem) and 4 (impossible). Items are summed to derive a total score (with between 0-60) , with higher total scores indicating greater disability.
change from baseline to end of the 1 week and 4 weeks
Pain Coping Questionnaire
Time Frame: change from baseline to end of the 1 week and 4 weeks
Evaluates the coping strategies of children and adolescents with a total of 39 items in 8 subscales. These are seeking knowledge, problem solving, seeking social support, positive self-suggestion, behavioural distraction, cognitive distraction, externalization, and internalization/catastrophizing. Items are assessed on a 5-point Likert scale, with 1 indicating never and 5 indicating very often. Higher ratings indicate higher use of coping strategy. PCQ consists of parent and adolescent form.The scores for each subscale are calculated by averaging the items. Higher scores indicate that the child uses strategies to cope more frequently.
change from baseline to end of the 1 week and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation and Environment- Children and Youth
Time Frame: change from baseline to end of the 1 week and 4 weeks
The participation sections included 10 activities in the home setting, five activities in the school setting, and 10 in the community setting. For each activity, the range of participation is daily to never, with scores between 0 and 8; higher scores indicate greater participation. The range of involvement is from very involved to minimally involved, with scores between 1 and 5; higher scores indicate greater involvement. The range of whether change is desired in the child's participation in this kind of activity is no or yes, with scores between 0 and 1. Environmental features supports and barriers (e.g., do the features of the environment help or make it harder?) for the child to participate in activities at home, school, or in a community setting with scores between 1 and 4; increased scores indicate environmental help.
change from baseline to end of the 1 week and 4 weeks
Pediatric Quality of Life Inventory
Time Frame: change from baseline to end of the 1 week and 4 weeks
Pediatric Quality of Life Inventory is a health-related quality-of-life scale for children and adolescents aged 2 to 18. There are three areas in which you can score. The first is the scale total score, followed by the physical health total score, and finally the psychosocial health total score, which is calculated from the item scores assessing emotional, social, and school functions. The Pediatric Quality of Life Inventory is a 23-item quality of life scale that is appropriate for use in large groups such as schools and hospitals, as well as in both healthy and unhealthy children and adolescents. The items are graded on a scale of 0 to 100. The answer is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as occasionally, 25 if it is marked as frequently, and 0 if it is marked as almost constantly. The higher the total PedsQL score, the higher the perceived health-related quality of life.
change from baseline to end of the 1 week and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Ozgun Kaya Kara, Assoc. Prof., Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

May 16, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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