CastingNCT07845136
The Effect of a Riddle-Based Distraction Technique on Pain, Fear, and Anxiety During Cast Application in Children: A Randomized Study
A study testing Riddle-Based Distraction in people with Casting and Fracture Dislocation, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of a riddle-based distraction intervention, administered during cast application in children, on levels of pain, fear, and anxiety. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Casting, Fracture Dislocation
- What is being tested?
- Riddle-Based Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 6 and 12 years of age
- Scheduled for cast application (upper or lower extremity)
- Conscious and able to communicate
- Able to understand and speak Turkish
- Having no auditory or cognitive impairments
- Having no prior exposure to a similar non-pharmacological distraction intervention
- Willingness of both the child and parent to participate in the study
Who cannot join
- Being under the influence of analgesic, sedative, or anxiolytic medication
- Having severe trauma or an unstable clinical condition requiring emergency intervention
- Presence of developmental delay, neurological disease, or conditions affecting communication
- Inability to participate in riddles due to hearing or visual impairment
- Having prior cast experience on the same extremity
- Inability to cooperate during the research process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kilis Prof. Dr. Alaeddin Yavaşca State Hospital
Kilis, Central
Elif Simay KOÇ, 2, +903488142666, elifsimay.koc@kilis.edu.tr
About this study
The aim of this study is to determine the effect of a riddle-based distraction intervention, administered during cast application in children, on levels of pain, fear, and anxiety.
Read the detailed description
Thirty-eight volunteer children aged 6-12 presenting to the Emergency Department Green Zone Cast Room at hospital for cast application (upper or lower extremity) will be randomly divided into two groups: intervention (riddle-based distraction) and control group. Children will be assessed before and during/after the procedure. Pain related to the cast application will be assessed with the Wong-Baker Faces Pain Scale, fear with the Child Fear Scale, and anxiety levels with the State-Trait Anxiety Inventory for Children (STAIC). In addition, children's sociodemographic and clinical data will be recorded in the Information Form.
- Conditions
- Casting, Fracture Dislocation
- Being tested
- Riddle-Based Distraction
- Keywords
- Pain, Fear, Anxiety, Cast Application, Pediatric Patients
- Medical subject headings
- Fracture Dislocation, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riddle-Based DistractionOther
Children who come to the hospital's cast room and meet the research criteria will be randomly assigned to the intervention group. The baseline scales and information forms will be filled out by the researcher through interviews with the child and parent before the cast application. Before the research, a pool of short, clear, and age-appropriate riddles will be prepared in consultation with experts, taking into account the cognitive levels of children aged 6-12. Prior to the procedure, brief communication will be established with the child to introduce the riddle game. During the cast preparation (preparing materials and positioning the extremity) and throughout the entire cast application process (wrapping, shaping, and setting the cast), the researcher will continuously ask the child riddles. The child's active participation will be encouraged by providing hints when needed and offering positive feedback. Active distraction turns the frightening cast room into an engaging space.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Before and during the cast application, the child will be asked age-appropriate simple riddles, encouraged to actively participate through clues, and their attention will be distracted from the procedure. Receives: Other: Riddle-Based Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
It is a form consisting of 4 questions in total, including the child's age, gender, previous fracture experience, and if any, how many times the child has experienced a fracture. It was prepared by the researcher in accordance with the literature.
Measured: Baseline
Wong-Baker FACES Pain Rating Scale
This scale was developed by Donna Wong and Connie Moran Baker in 1981 to assess pain levels in children. Suitable for children aged 3-18 years, the scale consists of 6 facial expressions scored from '0' to '10'. A score of "0" indicates no pain, while a score of "10" represents the worst possible pain. In our study, the child will be shown the facial expressions on the scale, asked to choose the face that best describes their pain, and the corresponding score will be recorded.
Measured: Baseline and up to 4 weeks
Child Fear Scale - CFS
Developed by McMurtry and colleagues, the Turkish validity of this scale was conducted by Gerçeker and colleagues. The changes in the facial muscles of a frightened expression were drawn by a graphic artist from a photograph of a frightened face. The scale features facial expressions scored from 0 to 4, where "0" indicates a neutral expression (no fear), "1" indicates a very low level of fear, "2" indicates a little fear, "3" indicates a greater level of fear, and "4" indicates the highest level of fear. In our study, the child will be shown the facial expressions on the fear scale, asked to select how they feel, and the corresponding score will be recorded.
Measured: Baseline and up to 4 weeks
State-Trait Anxiety Inventory for Children - STAIC / Thermometer
Developed to measure anxiety in children, the Turkish validity of this tool was confirmed by Gerçeker and colleagues (Ayar et al.). The scale utilizes a thermometer visual with a bulb at the bottom representing a score of "0" and lines extending upwards divided into 10 sections reaching a score of "10". The child is explained that as their finger moves up from the bulb, their anxiety increases, whereas the bulb represents playing happily with friends. In our study, the child will be asked to point to the thermometer according to how they feel during the procedure, and the corresponding score will be recorded.
Measured: Baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CastingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Gamze AKAY, 1, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845136
- Sponsor's protocol ID
- Riddle-Based in Children
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
PubMed 41588469
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Riddle-Based Distraction Technique on Pain, Fear, and Anxiety During Cast Application in Children: A Randomized Study
- ClinicalTrials.gov ID
- NCT07845136
- Acronym / sponsor ID
- Riddle-Based in Children
- Conditions
- Casting, Fracture Dislocation
- Keywords
- Pain, Fear, Anxiety, Cast Application, Pediatric Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Sep 2026 (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 determine the effect of a riddle-based distraction intervention, administered during cast application in children, on levels of pain, fear, and anxiety.
Detailed description
Thirty-eight volunteer children aged 6-12 presenting to the Emergency Department Green Zone Cast Room at hospital for cast application (upper or lower extremity) will be randomly divided into two groups: intervention (riddle-based distraction) and control group. Children will be assessed before and during/after the procedure. Pain related to the cast application will be assessed with the Wong-Baker Faces Pain Scale, fear with the Child Fear Scale, and anxiety levels with the State-Trait Anxiety Inventory for Children (STAIC). In addition, children's sociodemographic and clinical data will be recorded in the Information Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Riddle-Based DistractionBefore and during the cast application, the child will be asked age-appropriate simple riddles, encouraged to actively participate through clues, and their attention will be distracted from the procedure. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being between 6 and 12 years of age
- Scheduled for cast application (upper or lower extremity)
- Conscious and able to communicate
- Able to understand and speak Turkish
- Having no auditory or cognitive impairments
Key exclusion criteria (6 listed)
- Being under the influence of analgesic, sedative, or anxiolytic medication
- Having severe trauma or an unstable clinical condition requiring emergency intervention
- Presence of developmental delay, neurological disease, or conditions affecting communication
- Inability to participate in riddles due to hearing or visual impairment
- Having prior cast experience on the same extremity
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 |
|---|---|---|
| Riddle-Based DistractionChildren who come to the hospital's cast room and meet the research criteria will be randomly assigned to the intervention group. The baseline scales and information forms will be filled out by the researcher through interviews with the child and parent before the cast application. Before the research, a pool of short, clear, and age-appropriate riddles will be prepared in consultation with experts, taking into account the cognitive levels of children aged 6-12. Prior to the procedure, brief communication will be established with the child to introduce the riddle game. During the cast preparation (preparing materials and positioning the extremity) and throughout the entire cast application process (wrapping, shaping, and setting the cast), the researcher will continuously ask the child riddles. The child's active participation will be encouraged by providing hints when needed and offering positive feedback. Active distraction turns the frightening cast room into an engaging space. | Other | Experimental Group |
Primary outcome
Patient Identification Form
Time frame: Baseline
It is a form consisting of 4 questions in total, including the child's age, gender, previous fracture experience, and if any, how many times the child has experienced a fracture. It was prepared by the researcher in accordance with the literature.
Wong-Baker FACES Pain Rating Scale
Time frame: Baseline and up to 4 weeks
This scale was developed by Donna Wong and Connie Moran Baker in 1981 to assess pain levels in children. Suitable for children aged 3-18 years, the scale consists of 6 facial expressions scored from '0' to '10'. A score of "0" indicates no pain, while a score of "10" represents the worst possible pain. In our study, the child will be shown the facial expressions on the scale, asked to choose the face that best describes their pain, and the corresponding score will be recorded.
Child Fear Scale - CFS
Time frame: Baseline and up to 4 weeks
Developed by McMurtry and colleagues, the Turkish validity of this scale was conducted by Gerçeker and colleagues. The changes in the facial muscles of a frightened expression were drawn by a graphic artist from a photograph of a frightened face. The scale features facial expressions scored from 0 to 4, where "0" indicates a neutral expression (no fear), "1" indicates a very low level of fear, "2" indicates a little fear, "3" indicates a greater level of fear, and "4" indicates the highest level of fear. In our study, the child will be shown the facial expressions on the fear scale, asked to select how they feel, and the corresponding score will be recorded.
State-Trait Anxiety Inventory for Children - STAIC / Thermometer
Time frame: Baseline and up to 4 weeks
Developed to measure anxiety in children, the Turkish validity of this tool was confirmed by Gerçeker and colleagues (Ayar et al.). The scale utilizes a thermometer visual with a bulb at the bottom representing a score of "0" and lines extending upwards divided into 10 sections reaching a score of "10". The child is explained that as their finger moves up from the bulb, their anxiety increases, whereas the bulb represents playing happily with friends. In our study, the child will be asked to point to the thermometer according to how they feel during the procedure, and the corresponding score will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Results publication: PubMed 41588469Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
- Randomized Controlled TrialLink provided by the sponsor.
- 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.
Gamze AKAY, 1 principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riddle-Based Distraction in people with Casting and Fracture Dislocation, run by Artvin Coruh 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze AKAY, 1 (05314536661, gamzeakay_25@artvin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: Baseline). The study lists 4 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 NCT07845136, which also lists 1 linked publication.
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 28 Sep 2026.