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The Development and Evaluation of Pain Neuroscience Education in Children

Primary Purpose

Chronic Pain, Child, Only

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
culture-sensitive PNE4kids
standard education
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Children, Pain Neuroscience Education, Physical Therapy

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chronic pain group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Wong-Baker Faces Scale
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.
Pain Vigilance and Awareness Questionnaire Child & Adult Version
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.
Fear of Pain Questionnaire for Children/Parents
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.
Pain Catastrophizing Scale- Child
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.
Functional Disability Inventory
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.
Pain Coping Questionnaire
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.

Secondary Outcome Measures

Participation and Environment- Children and Youth
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.
Pediatric Quality of Life Inventory
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.

Full Information

First Posted
May 31, 2023
Last Updated
July 5, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05943587
Brief Title
The Development and Evaluation of Pain Neuroscience Education in Children
Official Title
The Development and Evaluation of Culturally Sensitive Pain Neuroscience Education in Children With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
May 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Child, Only
Keywords
Chronic Pain, Children, Pain Neuroscience Education, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial, Modified Delphi Study
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blind to the group allocation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic pain group
Arm Type
Experimental
Arm Description
30-45 minute individual sessions of culture-sensitive PNE4kids training will be applied.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
30-45 minute individual sessions of standard education training will be applied.
Intervention Type
Other
Intervention Name(s)
culture-sensitive PNE4kids
Intervention Description
Culturally adapted PNE4kids used by physiotherapists worldwide in chronic pain rehabilitation.
Intervention Type
Other
Intervention Name(s)
standard education
Intervention Description
Standard education used by physiotherapists worldwide in chronic pain rehabilitation.
Primary Outcome Measure Information:
Title
Wong-Baker Faces Scale
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Pain Vigilance and Awareness Questionnaire Child & Adult Version
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Fear of Pain Questionnaire for Children/Parents
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Pain Catastrophizing Scale- Child
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Functional Disability Inventory
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Pain Coping Questionnaire
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Secondary Outcome Measure Information:
Title
Participation and Environment- Children and Youth
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks
Title
Pediatric Quality of Life Inventory
Description
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.
Time Frame
change from baseline to end of the 1 week and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ishak Isık, Prof. Dr.
Phone
02422494400
Email
etik.kurul.07@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ishak Isık, Prof
Phone
02422494400
Email
etik.kurul.07@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozgun Kaya Kara, Assoc. Prof.
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozgun KAYA KARA, Assoc. Prof.
Email
ozgunkara@akdeniz.edu.tr
First Name & Middle Initial & Last Name & Degree
ceren Gursen, Assoc.Prof
First Name & Middle Initial & Last Name & Degree
Kelly Ickmans, Assoc.Prof
First Name & Middle Initial & Last Name & Degree
Emma Rheel, PT
First Name & Middle Initial & Last Name & Degree
Ozgun Kaya Kara, Assoc.Prof
First Name & Middle Initial & Last Name & Degree
Koray Kara, Assoc.Prof
First Name & Middle Initial & Last Name & Degree
Gultekin Kutluk, MD
First Name & Middle Initial & Last Name & Degree
Yaprak Cetin, Assoc. Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17678852
Citation
Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron. 2007 Aug 2;55(3):377-91. doi: 10.1016/j.neuron.2007.07.012.
Results Reference
background
PubMed Identifier
29550259
Citation
Pas R, Meeus M, Malfliet A, Baert I, Oosterwijck SV, Leysen L, Nijs J, Ickmans K. Development and feasibility testing of a Pain Neuroscience Education program for children with chronic pain: treatment protocol. Braz J Phys Ther. 2018 May-Jun;22(3):248-253. doi: 10.1016/j.bjpt.2018.02.004. Epub 2018 Mar 4.
Results Reference
background
PubMed Identifier
27351541
Citation
Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
Results Reference
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PubMed Identifier
28579013
Citation
Malfliet A, Leysen L, Pas R, Kuppens K, Nijs J, Van Wilgen P, Huysmans E, Goudman L, Ickmans K. Modern pain neuroscience in clinical practice: applied to post-cancer, paediatric and sports-related pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):225-232. doi: 10.1016/j.bjpt.2017.05.009. Epub 2017 May 19.
Results Reference
background
PubMed Identifier
25247901
Citation
Nijs J, Torres-Cueco R, van Wilgen CP, Girbes EL, Struyf F, Roussel N, van Oosterwijck J, Daenen L, Kuppens K, Vanwerweeen L, Hermans L, Beckwee D, Voogt L, Clark J, Moloney N, Meeus M. Applying modern pain neuroscience in clinical practice: criteria for the classification of central sensitization pain. Pain Physician. 2014 Sep-Oct;17(5):447-57.
Results Reference
background
PubMed Identifier
26051220
Citation
Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
Results Reference
background
PubMed Identifier
30831273
Citation
Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.
Results Reference
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PubMed Identifier
28009822
Citation
Robins H, Perron V, Heathcote LC, Simons LE. Pain Neuroscience Education: State of the Art and Application in Pediatrics. Children (Basel). 2016 Dec 21;3(4):43. doi: 10.3390/children3040043.
Results Reference
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PubMed Identifier
33863860
Citation
Siddall B, Ram A, Jones MD, Booth J, Perriman D, Summers SJ. Short-term impact of combining pain neuroscience education with exercise for chronic musculoskeletal pain: a systematic review and meta-analysis. Pain. 2022 Jan 1;163(1):e20-e30. doi: 10.1097/j.pain.0000000000002308.
Results Reference
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The Development and Evaluation of Pain Neuroscience Education in Children

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