FearNCT05439434
Turkish Reliability and Validity of FOPQC-SF
A study testing Fear of Pain Questionnaire for Children Short Form in people with Fear and Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Fear, Pain, Juvenile Idiopathic Arthritis
- What is being tested?
- Fear of Pain Questionnaire for Children Short Form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 15 Jun 2023
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with JIA according to the ILAR classification
- 7-18 years old
- Agree to participate in the study
Who cannot join
- Psychiatric illness that may affect cooperation,
- Those with heart failure and lung pathology at a level that will affect their daily life activities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20070
About this study
Official title: Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis
The aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.
- Conditions
- Fear, Pain, Juvenile Idiopathic Arthritis
- Being tested
- Fear of Pain Questionnaire for Children Short Form
- Medical subject headings
- Pain, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of Pain Questionnaire for Children Short FormOther
administering the questionnaire twice, one week apart.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Fear of Pain Questionnaire for Children Short Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Pain Questionnaire for Children Short Form
It consists of 10 items in total. All items are scored between O-4. Higher scores indicate higher levels of pain-related fear and avoidance.
Measured: 10 minutes
Secondary outcomes (3)
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Total score ranging from 0-100. High scores mean high quality of life.
Measured: 15 minutes
Juvenile Arthritis Disease Activity Score
Total JADAS score ranging from 0-57. Higher score indicates more disease activity.
Measured: 10 minutes
Childhood Health Assessment Questionnaire
It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start20 Nov 2022
- Primary completion20 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gur Kabul, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439434
- Sponsor's protocol ID
- FOPQC-SF
- Status last verified
- Sep 2023
- First submitted
- 26 Jun 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05439434
- Acronym / sponsor ID
- FOPQC-SF
- Conditions
- Fear, Pain, Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 30 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 aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Fear of Pain Questionnaire for Children Short Form |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being diagnosed with JIA according to the ILAR classification
- 7-18 years old
- Agree to participate in the study
Key exclusion criteria (2 listed)
- Psychiatric illness that may affect cooperation,
- Those with heart failure and lung pathology at a level that will affect their daily life activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear of Pain Questionnaire for Children Short Formadministering the questionnaire twice, one week apart. | Other | intervention group |
Primary outcome
Fear of Pain Questionnaire for Children Short Form
Time frame: 10 minutes
It consists of 10 items in total. All items are scored between O-4. Higher scores indicate higher levels of pain-related fear and avoidance.
3 secondary outcomes
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
Time frame: 15 minutes
Juvenile Arthritis Disease Activity Score
Time frame: 10 minutes
Childhood Health Assessment Questionnaire
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear of Pain Questionnaire for Children Short Form in people with Fear and Pain, run by Pamukkale 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Pain Questionnaire for Children Short Form (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.