Pain ManagementKHALPAINNCT07068672
Kaleidoscope and Helicone for Pain and Anxiety in Children
A study testing Kaleidoscope and Helicone in people with Pain Management and Procedural Pain, run by AYLİN ARIKAN at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effects of kaleidoscope and helicone distraction tools on pain and anxiety levels during venipuncture in school-age children. The study was conducted at Ankara Etlik City Hospital Pediatric Emergency Department between April and May 2025. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Procedural Pain, Children
- What is being tested?
- Kaleidoscope and Helicone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 May 2025
- 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
- Children aged between 6 and 12 years
- Requiring venipuncture for clinical purposes
- Able to verbally communicate pain and anxiety
- Accompanied by a parent or legal guardian who provides written informed consent
- Child provides verbal assent to participate
Who cannot join
- Children with cognitive or neurological disorders affecting pain or anxiety perception
- Use of any analgesics, anxiolytics, or sedatives within 6 hours prior to the procedure
- Visual or hearing impairments that interfere with the use of kaleidoscope or helicone
- Previous experience with similar distraction tools
- Presence of any skin condition preventing pain scale assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Etlik, 06270
About this study
Official title: Effect of Kaleidoscope and Helicone Use on Pain and Anxiety During Venipuncture in School-Age Children: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effects of kaleidoscope and helicone distraction tools on pain and anxiety levels during venipuncture in school-age children. The study was conducted at Ankara Etlik City Hospital Pediatric Emergency Department between April and May 2025. A total of 210 children aged 6 to 12 years who were undergoing venous blood sampling for the first time were randomly assigned to one of three groups: Kaleidoscope, Helicone, or Control (standard care). The Kaleidoscope group used a passive distraction tool featuring dynamic visual patterns; the Helicone group used an active distraction tool that involves hand manipulation of a rotating toy. Pain levels were measured using the Wong-Baker FACES Pain Rating Scale, and anxiety levels were assessed using the Children's Anxiety Meter-State (CAM-S). Measurements were taken before, during, and after the procedure. This study seeks to determine the comparative effectiveness of active versus passive distraction techniques in pediatric procedural pain and anxiety management. All interventions were non-pharmacological, non-invasive, and conducted in a safe clinical setting with informed consent obtained from both children and their guardians.
- Conditions
- Pain Management, Procedural Pain, Children, Pediatric Nursing
- Being tested
- Kaleidoscope, Helicone
- Keywords
- Kaleidoscope, Helicone, Pediatric Pain Management, School-Age Children, Venipuncture
- Medical subject headings
- Agnosia, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaleidoscopeBehavioural
A handheld kaleidoscope was used as a passive distraction tool during venipuncture. The device was introduced to the child 2 minutes before the procedure and remained in view during blood collection. It provided dynamic, colorful visual stimuli to help reduce pain and anxiety.
HeliconeBehavioural
A helicone toy was used as an active distraction tool. Children held and rotated the device beginning 2 minutes before and during venipuncture. The interactive movement and shape-shifting design engaged the child's attention to reduce procedural pain and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope Group | Experimental | Children in this group were provided with a handheld kaleidoscope starting 2 minutes before and during venipuncture. The visual distraction created by the kaleidoscope's changing colorful patterns aimed to reduce pain and anxiety. The child focused on the visual display throughout the procedure. Receives: Behavioral: Kaleidoscope |
| Helicone Group | Experimental | Children in this group used a helicone toy starting 2 minutes before and during venipuncture. The toy, which changes shape with hand manipulation, provided active distraction to reduce pain and anxiety by engaging both visual and tactile senses. Receives: Behavioral: Helicone |
| Control Group | No intervention | Children in this group received standard care during venipuncture without any distraction tools. No visual or tactile distraction was provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level measured using Wong-Baker FACES Pain Scale
Pain was assessed by the child using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where higher scores indicate more severe pain. Evaluations were conducted at three time points: before the procedure, during needle insertion, and two minutes after.
Measured: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Anxiety level measured using Children's Anxiety Meter - State (CAM-S)
Anxiety was evaluated using the Children's Anxiety Meter - State (CAM-S) tool. The scale ranges from 0 (no anxiety) to 10 (extreme anxiety). Assessments were completed by the child with assistance from the researcher at three time points: before, during, and after the venipuncture.
Measured: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Apr 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- AYLİN ARIKAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYLİN ARIKAN, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068672
- Sponsor's protocol ID
- AESH-B-2025-0123
- Other IDs
- AEŞH-BADEK-2025-0123
- Acronym
- KHALPAIN
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kaleidoscope and Helicone Use on Pain and Anxiety During Venipuncture in School-Age Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07068672
- Acronym / sponsor ID
- KHALPAIN / AESH-B-2025-0123
- Conditions
- Pain Management, Procedural Pain, Children, Pediatric Nursing
- Keywords
- Kaleidoscope, Helicone, Pediatric Pain Management, School-Age Children, Venipuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- AYLİN ARIKANUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 16 Jul 2025 (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.
This randomized controlled trial aimed to evaluate the effects of kaleidoscope and helicone distraction tools on pain and anxiety levels during venipuncture in school-age children. The study was conducted at Ankara Etlik City Hospital Pediatric Emergency Department between April and May 2025. A total of 210 children aged 6 to 12 years who were undergoing venous blood sampling for the first time were randomly assigned to one of three groups: Kaleidoscope, Helicone, or Control (standard care). The Kaleidoscope group used a passive distraction tool featuring dynamic visual patterns; the Helicone group used an active distraction tool that involves hand manipulation of a rotating toy. Pain levels were measured using the Wong-Baker FACES Pain Rating Scale, and anxiety levels were assessed using the Children's Anxiety Meter-State (CAM-S). Measurements were taken before, during, and after the procedure. This study seeks to determine the comparative effectiveness of active versus passive distraction techniques in pediatric procedural pain and anxiety management. All interventions were non-pharmacological, non-invasive, and conducted in a safe clinical setting with informed consent obtained from both children and their guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope Group | Experimental | Behavioral: KaleidoscopeChildren in this group were provided with a handheld kaleidoscope starting 2 minutes before and during venipuncture. The visual distraction created by the kaleidoscope's changing colorful patterns aimed to reduce pain and anxiety. The child focused on the visual display throughout the procedure. |
| Helicone Group | Experimental | Behavioral: HeliconeChildren in this group used a helicone toy starting 2 minutes before and during venipuncture. The toy, which changes shape with hand manipulation, provided active distraction to reduce pain and anxiety by engaging both visual and tactile senses. |
| Control Group | No intervention | –Children in this group received standard care during venipuncture without any distraction tools. No visual or tactile distraction was provided. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 6 and 12 years
- Requiring venipuncture for clinical purposes
- Able to verbally communicate pain and anxiety
- Accompanied by a parent or legal guardian who provides written informed consent
- Child provides verbal assent to participate
Key exclusion criteria (5 listed)
- Children with cognitive or neurological disorders affecting pain or anxiety perception
- Use of any analgesics, anxiolytics, or sedatives within 6 hours prior to the procedure
- Visual or hearing impairments that interfere with the use of kaleidoscope or helicone
- Previous experience with similar distraction tools
- Presence of any skin condition preventing pain scale assessment
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 |
|---|---|---|
| KaleidoscopeA handheld kaleidoscope was used as a passive distraction tool during venipuncture. The device was introduced to the child 2 minutes before the procedure and remained in view during blood collection. It provided dynamic, colorful visual stimuli to help reduce pain and anxiety. | Behavioural | Kaleidoscope Group |
| HeliconeA helicone toy was used as an active distraction tool. Children held and rotated the device beginning 2 minutes before and during venipuncture. The interactive movement and shape-shifting design engaged the child's attention to reduce procedural pain and anxiety. | Behavioural | Helicone Group |
Primary outcome
Pain level measured using Wong-Baker FACES Pain Scale
Time frame: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Pain was assessed by the child using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where higher scores indicate more severe pain. Evaluations were conducted at three time points: before the procedure, during needle insertion, and two minutes after.
Anxiety level measured using Children's Anxiety Meter - State (CAM-S)
Time frame: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Anxiety was evaluated using the Children's Anxiety Meter - State (CAM-S) tool. The scale ranges from 0 (no anxiety) to 10 (extreme anxiety). Assessments were completed by the child with assistance from the researcher at three time points: before, during, and after the venipuncture.
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 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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 Kaleidoscope and Helicone in people with Pain Management and Procedural Pain, run by AYLİN ARIKAN 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 5 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 18 Jul 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?
Pain level measured using Wong-Baker FACES Pain Scale (time frame: Two minutes before the procedure, during needle insertion, and two minutes after the procedure). The study lists 2 primary outcomes in all. 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 18 Jul 2025.