Chronic PainNCT05422456
The Turkish Version of Functional Disability Inventory
An observational study of Chronic Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to determine the validity and reliability of the Turkish version of the Functional Disability Inventory (FDI), which assesses functional disability in daily life, school, and home activities of children aged 8 to 18, as well as to ensure cultural adaptation of this measurement. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2022to 12 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children are diagnosed with chronic headache and their health peers
Who may be able to join
- Clinical diagnosis of chronic pain
- Age between 8-18 years
- Native language is Turkish
- Not diagnosed of chronic pain and psychiatric and neurological disease
- Aged at 8-18 years old
- Native language is Turkish
Who cannot join
- Diagnosis of autism spectrum disorder and attention deficit and hyperactivity disorder, psychotic symptoms, depression, etc.
- Children whose parents or themselves refused to participate
- Native language is not Turkish
Trial locations and contacts
1 site in 1 country.
Ozgun Kaya Kara, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya
Ozgun KAYA KARA, Assoc. Prof. PhD, ozgunkara@akdeniz.edu.tr
About this study
Official title: The Turkish Adaptation, Validity, and Reliability of the Functional Disability Inventory
The goal of this study is to determine the validity and reliability of the Turkish version of the Functional Disability Inventory (FDI), which assesses functional disability in daily life, school, and home activities of children aged 8 to 18, as well as to ensure cultural adaptation of this measurement. Chronic pain is the most frequent type of pain in children and adolescents, affecting one-quarter of the population. Children and adolescents with chronic pain have difficulty completing activities such as walking, jogging, and participating in sports, as well as daily activities. There is no valid and reliable measurement that measures pain-related disability in everyday life, at home, or at school from the perspective of a child in the literature. This study hypothesizes that the Functional Disability Inventory is a valid and reliable measurement for measuring functional disability in the Turkish population of children with chronic pain.
Read the detailed description
Chronic pain in children and adolescents is defined as pain that lasts longer than three months and is unabsorbable. Approximately 5% of the children said they were suffering from moderate to severe chronic pain, as well as impairments in their physical and psychosocial functions. Children and adolescents with chronic pain have difficulty completing activities such as walking, jogging, and participating in sports, as well as daily activities. Schoolchildren with chronic pain, for example, were shown to be five times more likely than their classmates without pain to miss school (13.9 percent vs. 2.4 percent), and it has been observed that absenteeism from school increases the likelihood of grade repeat in children with chronic pain.
Headaches affect between 57 and 82 percent of children and adolescents aged 7 to 15. It is wrong to believe that a headache with this frequency and associated concomitant conditions does not result in functional disability and limitations in everyday activities. When compared to their peers without headaches, 62 percent of children and adolescents with headaches reported more functional disability due to moderate to severe headache, limitation in daily activities, and absenteeism from school. Pain and functional incapacity caused by pain cannot be assumed to have no impact on a person's ability to participate in activities. The term "participation" refers to a person's involvement in the circumstances of his or her life. Participation in daily activities is critical for all children's healthy development, regardless of their age.
The fundamental goal of functional evaluation is to demonstrate a person's ability to function in society independently. This skill is employed in everyday activities such as personal care, social contact, housework, and recreational activities. The importance of these functions in daily life in pediatric patients, on the other hand, receives less emphasis (5). Walker and Greene (1991) developed the Functional Disability Inventory (FDI) to assess impairments in children and adolescents caused by a variety of pediatric health conditions (6). There are fifteen items in the FDI category. These tasks are used to assess how difficult it is for the youngster to walk, climb stairs, eat, do household chores, go to school, participate in sports, read and write, and watch television.
On a four-point Likert scale, (0=no issue, 4=impossible), each item is rated. With the child's own report, FDI assesses the difficulty in physical and psychological functions caused by the child's physical health. It is determined by taking into account the child's activity restrictions throughout the previous two weeks. The scale runs from 0 to 60. The total score is calculated by summing the individual item scores. A higher score indicates a higher level of disability. The purpose of this study is to see if the Turkish version of the Functional Disability Inventory (FDI) is valid and reliable in a Turkish sample of children with chronic pain.
- Conditions
- Chronic Pain
- Keywords
- pediatric, chronic pain, headache, functional disability
- Medical subject headings
- Chronic Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain group | children are diagnosed with chronic headache by pediatric neurologist | |
| Health group | children without chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional disability
Functional Disability Inventory (FDI) is 15 item self-report measurement designed to evaluate functional disability in children while they were doing various activities. Each item scored 0 to 4; 0 represents no trouble and 4 represents impossible.
Measured: Baseline
Evaluation of severity of pain
Wong-Baker Face Pain Scale is valid and reliable measurement preferred by children and parents to evaluate severity of pain. It consists of 6 face expression that symbolized pain severity. These Show the stages of increased pain from smiling face (0 point) to a very sad and crying face (10 points). Children rate their current pain between these faces.
Measured: Baseline
Evaluation of pain
In several pediatric diagnostic groups, the Adolescent Pediatric Pain Tool (APPT) is applied for pain assessment APPT can be used on children aged 7 to 18. The APPT consists of three separate parts. First, the body diagram allows the child to indicate the location of the pain. Second, pain intensity was rated on a scale from "no pain" to "worst possible pain" based on 5-point Likert scale. Finally, the characteristics of pain and 67 words describing pain are indicated.
Measured: Baseline
Secondary outcomes (4)
Evaluation of somatization
Children's Somatization Inventory is a scale that evaluates the child's symptoms experienced in the last two weeks in both parent and child forms and the child's somatization symptoms from both perspectives. Total score is obtained by adding up all the scores. Higher scores indicate greater somatization complaints. Scores range from 0 to 96.
Measured: Baseline
Evaluation of quality of life
Pediatric Quality of Life Inventory is a generic health related quality of life measure consisting of four core scales, physical function (8 items), emotional function (5 items), social function (5 items) and school function (5 items) that is intended for use in healthy and patient populations. Respondents are asked to recall the last month and indicate how frequently - from never to almost always - they have experienced specific phenomena. Item responses (0-100) are averaged to form total and core scores; higher scores indicate higher functioning.
Measured: Baseline
Evaluation of anxiety
The measurement consists of two subscales as State Anxiety Scale and Trait Anxiety Scale. Each subscale has 20 items, and 40 items in total. State Anxiety scale assesses momentary subjective feelings in certain situations. Trait Anxiety Scale assesses continued subjective chronic feelings such as worry, anxiety and irritability. Total scores change between 20-80. Scores between 20-39 indicate mild, scores between 40-59 indicate moderate, scores between 60-79 indicate severe anxiety, and scores of 80 indicate panic.
Measured: Baseline
Evaluation of Depression
Children Depression Scale is a measurement that can be used in children aged 6-17. The scale evaluates using the child's own answers. It consists of 27 items. In these choices, there are "sometimes," "often" and "always" answers containing the item related to the question. Each item scored with 0,1,2. The highest score is 54, and higher scores indicating higher level of depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start8 Sep 2022
- Primary completion8 Aug 2023 (estimated)
- Study completion12 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
- Investigators
- Ozgun Kaya Kara, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422456
- Sponsor's protocol ID
- 2022-126
- Status last verified
- May 2023
- First submitted
- 8 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the results will be published in the journal
Publications
Murphy NA, Carbone PS; American Academy of Pediatrics Council on Children With Disabilities. Promoting the participation of children with disabilities in sports, recreation, and physical activities. Pediatrics. 2008 May;121(5):1057-61. doi: 10.1542/peds.2008-0566.
PubMed 18450913Sonagra M, Jones J, McGill M, Gmuca S. Exploring the intersection of adverse childhood experiences, pediatric chronic pain, and rheumatic disease. Pediatr Rheumatol Online J. 2022 Feb 14;20(1):14. doi: 10.1186/s12969-022-00674-x.
PubMed 35164793Offenbacher M, Kohls N, Walker L, Hermann C, Hugle B, Jager N, Richter M, Haas JP. Functional limitations in children and adolescents suffering from chronic pain: validation and psychometric properties of the German Functional Disability Inventory (FDI-G). Rheumatol Int. 2016 Oct;36(10):1439-48. doi: 10.1007/s00296-016-3504-5. Epub 2016 Jun 4.
PubMed 27262712Groenewald CB, Tham SW, Palermo TM. Impaired School Functioning in Children With Chronic Pain: A National Perspective. Clin J Pain. 2020 Sep;36(9):693-699. doi: 10.1097/AJP.0000000000000850.
PubMed 32487871Ferracini GN, Dach F, Speciali JG. Quality of life and health-related disability in children with migraine. Headache. 2014 Feb;54(2):325-34. doi: 10.1111/head.12251. Epub 2013 Oct 29.
PubMed 24512577Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
PubMed 16480823Koklukaya HN, Kaya Kara O, Karademir S, Dogan M, Kutluk MG, Kara K. An evaluation of the validity, reliability, and psychometric properties of the Turkish version of the functional disability inventory in children and adolescents with chronic pain. J Pediatr Nurs. 2025 May-Jun;82:e126-e133. doi: 10.1016/j.pedn.2025.04.005. Epub 2025 Apr 17.
PubMed 40251104
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Adaptation, Validity, and Reliability of the Functional Disability Inventory
- ClinicalTrials.gov ID
- NCT05422456
- Acronym / sponsor ID
- 2022-126
- Conditions
- Chronic Pain
- Keywords
- pediatric, chronic pain, headache, functional disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 8 Aug 2023 (estimated)
- Study completion
- 12 Aug 2023 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the validity and reliability of the Turkish version of the Functional Disability Inventory (FDI), which assesses functional disability in daily life, school, and home activities of children aged 8 to 18, as well as to ensure cultural adaptation of this measurement. Chronic pain is the most frequent type of pain in children and adolescents, affecting one-quarter of the population. Children and adolescents with chronic pain have difficulty completing activities such as walking, jogging, and participating in sports, as well as daily activities. There is no valid and reliable measurement that measures pain-related disability in everyday life, at home, or at school from the perspective of a child in the literature. This study hypothesizes that the Functional Disability Inventory is a valid and reliable measurement for measuring functional disability in the Turkish population of children with chronic pain.
Detailed description
Chronic pain in children and adolescents is defined as pain that lasts longer than three months and is unabsorbable. Approximately 5% of the children said they were suffering from moderate to severe chronic pain, as well as impairments in their physical and psychosocial functions. Children and adolescents with chronic pain have difficulty completing activities such as walking, jogging, and participating in sports, as well as daily activities. Schoolchildren with chronic pain, for example, were shown to be five times more likely than their classmates without pain to miss school (13.9 percent vs. 2.4 percent), and it has been observed that absenteeism from school increases the likelihood of grade repeat in children with chronic pain.
Headaches affect between 57 and 82 percent of children and adolescents aged 7 to 15. It is wrong to believe that a headache with this frequency and associated concomitant conditions does not result in functional disability and limitations in everyday activities. When compared to their peers without headaches, 62 percent of children and adolescents with headaches reported more functional disability due to moderate to severe headache, limitation in daily activities, and absenteeism from school. Pain and functional incapacity caused by pain cannot be assumed to have no impact on a person's ability to participate in activities. The term "participation" refers to a person's involvement in the circumstances of his or her life. Participation in daily activities is critical for all children's healthy development, regardless of their age.
The fundamental goal of functional evaluation is to demonstrate a person's ability to function in society independently. This skill is employed in everyday activities such as personal care, social contact, housework, and recreational activities. The importance of these functions in daily life in pediatric patients, on the other hand, receives less emphasis (5). Walker and Greene (1991) developed the Functional Disability Inventory (FDI) to assess impairments in children and adolescents caused by a variety of pediatric health conditions (6). There are fifteen items in the FDI category. These tasks are used to assess how difficult it is for the youngster to walk, climb stairs, eat, do household chores, go to school, participate in sports, read and write, and watch television.
On a four-point Likert scale, (0=no issue, 4=impossible), each item is rated. With the child's own report, FDI assesses the difficulty in physical and psychological functions caused by the child's physical health. It is determined by taking into account the child's activity restrictions throughout the previous two weeks. The scale runs from 0 to 60. The total score is calculated by summing the individual item scores. A higher score indicates a higher level of disability. The purpose of this study is to see if the Turkish version of the Functional Disability Inventory (FDI) is valid and reliable in a Turkish sample of children with chronic pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain group | – | –children are diagnosed with chronic headache by pediatric neurologist |
| Health group | – | –children without chronic pain |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children are diagnosed with chronic headache and their health peers
Key inclusion criteria (6 listed)
- Clinical diagnosis of chronic pain
- Age between 8-18 years
- Native language is Turkish
- Not diagnosed of chronic pain and psychiatric and neurological disease
- Aged at 8-18 years old
Key exclusion criteria (3 listed)
- Diagnosis of autism spectrum disorder and attention deficit and hyperactivity disorder, psychotic symptoms, depression, etc.
- Children whose parents or themselves refused to participate
- Native language is not Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of functional disability
Time frame: Baseline
Functional Disability Inventory (FDI) is 15 item self-report measurement designed to evaluate functional disability in children while they were doing various activities. Each item scored 0 to 4; 0 represents no trouble and 4 represents impossible.
Evaluation of severity of pain
Time frame: Baseline
Wong-Baker Face Pain Scale is valid and reliable measurement preferred by children and parents to evaluate severity of pain. It consists of 6 face expression that symbolized pain severity. These Show the stages of increased pain from smiling face (0 point) to a very sad and crying face (10 points). Children rate their current pain between these faces.
Evaluation of pain
Time frame: Baseline
In several pediatric diagnostic groups, the Adolescent Pediatric Pain Tool (APPT) is applied for pain assessment APPT can be used on children aged 7 to 18. The APPT consists of three separate parts. First, the body diagram allows the child to indicate the location of the pain. Second, pain intensity was rated on a scale from "no pain" to "worst possible pain" based on 5-point Likert scale. Finally, the characteristics of pain and 67 words describing pain are indicated.
4 secondary outcomes
Evaluation of somatization
Time frame: Baseline
Evaluation of quality of life
Time frame: Baseline
Evaluation of anxiety
Time frame: Baseline
Evaluation of Depression
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 18450913Murphy NA, Carbone PS; American Academy of Pediatrics Council on Children With Disabilities. Promoting the participation of children with disabilities in sports, recreation, and physical activities. Pediatrics. 2008 May;121(5):1057-61. doi: 10.1542/peds.2008-0566.
- Results publication: PubMed 35164793Sonagra M, Jones J, McGill M, Gmuca S. Exploring the intersection of adverse childhood experiences, pediatric chronic pain, and rheumatic disease. Pediatr Rheumatol Online J. 2022 Feb 14;20(1):14. doi: 10.1186/s12969-022-00674-x.
- Results publication: PubMed 27262712Offenbacher M, Kohls N, Walker L, Hermann C, Hugle B, Jager N, Richter M, Haas JP. Functional limitations in children and adolescents suffering from chronic pain: validation and psychometric properties of the German Functional Disability Inventory (FDI-G). Rheumatol Int. 2016 Oct;36(10):1439-48. doi: 10.1007/s00296-016-3504-5. Epub 2016 Jun 4.
- Results publication: PubMed 32487871Groenewald CB, Tham SW, Palermo TM. Impaired School Functioning in Children With Chronic Pain: A National Perspective. Clin J Pain. 2020 Sep;36(9):693-699. doi: 10.1097/AJP.0000000000000850.
- Results publication: PubMed 24512577Ferracini GN, Dach F, Speciali JG. Quality of life and health-related disability in children with migraine. Headache. 2014 Feb;54(2):325-34. doi: 10.1111/head.12251. Epub 2013 Oct 29.
- Results publication: PubMed 16480823Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
- Derived from this study: PubMed 40251104Koklukaya HN, Kaya Kara O, Karademir S, Dogan M, Kutluk MG, Kara K. An evaluation of the validity, reliability, and psychometric properties of the Turkish version of the functional disability inventory in children and adolescents with chronic pain. J Pediatr Nurs. 2025 May-Jun;82:e126-e133. doi: 10.1016/j.pedn.2025.04.005. Epub 2025 Apr 17.
- Individual participant dataSharing planned: No. the results will be published in the journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgun Kaya Kara, Assoc. Prof. contact
Ozgun Kaya Kara study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ishak Isik, MD (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of functional disability (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422456, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.