Fracture; Complication Orthopedic ProcedureNCT06261112
The Effect of Using a Kaleidoscope on Fear and Pain in Children
A study testing kaleidescope in people with Fracture; Complication Orthopedic Procedure, run by Mihriban Culha at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture; Complication Orthopedic Procedure
- What is being tested?
- kaleidescope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2022to 1 Sep 2024
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child in the 6-12 age group,
- The child's willingness to participate in the study,
- The parent's volunteering to participate in the study,
- Absence of intellectual disability of the child and parent,
- The child and the parent speak Turkish and are open to communication.
Who cannot join
- The child has a chronic disease that can cause pain,
- The child has used analgesics within 24 hours before admission to the hospital,
- The child has visual impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Kaleidoscope on Pain and Fear in the Plastering Process of Fracture Emergencies
The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data.
Read the detailed description
Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:
The research was conducted between March 2022 and December 2023 as a randomized controlled experimental study. The study population consisted of patients who sought treatment at the Orthopedics Polyclinic and Emergency Department of Erzurum Atatürk University Health Research and Application Center. These patients were referred to the orthopedics clinic and diagnosed with fractures, such as humerus, wrist, finger, tibia, femur, and ankle fractures, for which plastering was performed as treatment. Specifically, the study included children aged 6 to 12 years. The sample size for the study was determined through a power analysis and ultimately consisted of a total of 70 children, with 35 children assigned to both the control group and the kaleidoscope group. The children in the kaleidoscope group were exposed to a kaleidoscope, while the control group received no intervention beyond routine medical practice. To collect data, the researchers utilized an "Introductory Information Form," the "Wong-Baker Faces Pain Rating Scale," and the "Children Fear Scale." The data were analyzed using percentage distributions, mean, standard deviation, chi-square test, and independent groups t-test. Throughout the research, ethical principles were strictly followed.
- Being tested
- kaleidescope
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kaleidescopeOther
used to kaleideskope
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group kaleideskope, pain and fear Receives: Other: kaleidescope |
| No intervention group | No intervention | No intervention group Control not pain and fear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale (CFS)
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0=n0 concern et all) to fearful (4=severe anxietly).
Measured: 12 MONTHS
Secondary outcomes (1)
Facial Expressions Rating Scale
This visual facial scale is a practical method to assess rhe level of anxiety within a situation. There are six facial expressions, ranging from very happy to very unhappy and children are asked to choose the one that comes closest to how they feel at that moment. The most positive face is scored as "0" and the most negative face as scored as "5".
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start7 May 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture; Complication Orthopedic ProcedureStudies 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
- Model description
- Parallel Assigment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mihriban Culha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mihriban Culha, Ataturk University
- Investigators
- Mihriban ÇULHA, Principal investigator, Mihriban ÇULHA, graduate student ,Ataturk UniversityMihriban ÇULHA, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261112
- Sponsor's protocol ID
- B.30.2.ATA.01.11/285
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTİCLE IS INTENDED TO BE SHARED AFTER PUBLİCATİON
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Kaleidoscope on Pain and Fear in the Plastering Process of Fracture Emergencies
- ClinicalTrials.gov ID
- NCT06261112
- Acronym / sponsor ID
- B.30.2.ATA.01.11/285
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mihriban CulhaUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 15 Feb 2024 (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 research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data.
Detailed description
Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:
The research was conducted between March 2022 and December 2023 as a randomized controlled experimental study. The study population consisted of patients who sought treatment at the Orthopedics Polyclinic and Emergency Department of Erzurum Atatürk University Health Research and Application Center. These patients were referred to the orthopedics clinic and diagnosed with fractures, such as humerus, wrist, finger, tibia, femur, and ankle fractures, for which plastering was performed as treatment. Specifically, the study included children aged 6 to 12 years. The sample size for the study was determined through a power analysis and ultimately consisted of a total of 70 children, with 35 children assigned to both the control group and the kaleidoscope group. The children in the kaleidoscope group were exposed to a kaleidoscope, while the control group received no intervention beyond routine medical practice. To collect data, the researchers utilized an "Introductory Information Form," the "Wong-Baker Faces Pain Rating Scale," and the "Children Fear Scale." The data were analyzed using percentage distributions, mean, standard deviation, chi-square test, and independent groups t-test. Throughout the research, ethical principles were strictly followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assigment
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: kaleidescopeExperimental group kaleideskope, pain and fear |
| No intervention group | No intervention | –No intervention group Control not pain and fear |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being a child in the 6-12 age group,
- The child's willingness to participate in the study,
- The parent's volunteering to participate in the study,
- Absence of intellectual disability of the child and parent,
- The child and the parent speak Turkish and are open to communication.
Key exclusion criteria (3 listed)
- The child has a chronic disease that can cause pain,
- The child has used analgesics within 24 hours before admission to the hospital,
- The child has visual impairment.
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 |
|---|---|---|
| kaleidescopeused to kaleideskope | Other | Experimental group |
Primary outcome
Child Fear Scale (CFS)
Time frame: 12 MONTHS
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0=n0 concern et all) to fearful (4=severe anxietly).
1 secondary outcome
Facial Expressions Rating Scale
Time frame: 12 MONTHS
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 21 Feb 2025.
- Individual participant dataSharing planned: No. THE ARTİCLE IS INTENDED TO BE SHARED AFTER PUBLİCATİON
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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.
Mihriban ÇULHA principal investigator
Mihriban ÇULHA, graduate student ,Ataturk University
Mihriban ÇULHA principal investigator
Ataturk 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 kaleidescope in people with Fracture; Complication Orthopedic Procedure, run by Mihriban Culha 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 5 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: finished, as of the sponsor's last update on 21 Feb 2025. 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?
Child Fear Scale (CFS) (time frame: 12 MONTHS). 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 21 Feb 2025.