To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous CatheterizationPIKNCT06772259
Comparison of the Effect of Two Different Interventions
A study testing Palm Stimulator and Cartoon in people with To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization
- What is being tested?
- Palm Stimulator and Cartoon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Mar 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary participation in the study,
- Pediatric patients for whom written and verbal consent has been obtained from the parent,
- Pediatric patients for whom verbal consent was obtained,
- Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.
Who cannot join
- Not volunteering to participate in the study,
- More than one PIK attempt,
- Children with a chronic, acute, or life-threatening illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Two Different Interventions on Pain and Fear in Peripheric Intravenous Catheterization in Children: A Randomized Controlled Study
The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.
Hypotheses:
Read more
H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.
H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.
H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.
H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.
H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.
H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.
H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.
H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.
H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.
H10: PIK application time is different in the palm stimulator group compared to the control group.
H11: PIK application time is different in the cartoon group compared to the co
Read the detailed description
- To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
- Measuring pain and fear levels by watching cartoons to children during PIK application
- Being tested
- Palm Stimulator, Cartoon
- Keywords
- pain, fear, children, distraction, palm stimulator, cartoon, peripheral intravenous, catheterization, cannulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm StimulatorDevice
The apparatus is 1.6 cm in diameter and 4 cm long. It has a cylindrical, non-slippery and easy-to-grasp structure for maximum contact with the palm
CartoonOther
The cartoon was projected on a blank wall in the intervention room with a projection device. The cartoon was played in preparation for the PIK procedure and children were allowed to watch it until the procedure was completed.
| Study group | Role | What they receive |
|---|---|---|
| Palm stimulator group | Experimental | The Palm Stimulator is grasped in the palm during painful interventions and provides stimulation. Blunt protrusions around the apparatus provide tactile stimulation in the palm. The blunt protrusions have been found to reduce the pain perceived during the intervention by closing the pain gate in the spinal cortex by creating stimuli according to the gate control pain theory without penetrating the skin. The researchers who developed the apparatus were contacted via e-mail and permission was obtained for using the palm stimulator.
In the study, the child held the palm stimulator in the palm during the PIK procedure, and the researcher evaluated pain and fear. After the PIK procedure was completed, the child was asked to release the apparatus from the palm. Receives: Device: Palm Stimulator |
| Cartoon group | Experimental | Distraction by watching cartoons is a promising, cost-effective, and non-pharmacologic technique to reduce pain in children undergoing painful procedures. The cartoon was selected by expert researchers from the pediatric field in the research team following the age and consciousness level of the children. A projection device was placed in the intervention room for data collection. The cartoon was projected on a blank wall in the intervention room. The cartoon was played in preparation for the PIK procedure, and children were allowed to watch it until it was completed. Receives: Other: Cartoon |
| Control gruup | No intervention | In the control group, the routine application phase was performed. Age-appropriate children were seated in the blood sampling chair, and those who could not sit were placed on a stretcher, and PIK was performed. The parent was also taken to the intervention room during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurement
Before, during, and after the PIK procedure in intervention and control groups. Wong-Baker FACES Pain Scale: The scale used to diagnose pain in children was developed by Donna Lee Wong and Connie Morain Baker. The Wong-Baker Scale has been reported to be safe to use in children aged 3-18 who can verbally describe the level of pain. The scale includes facial expressions and numbers. The scale has a total of six facial expressions, and pain is graded between 0-10 (Wong \& Baker, 1988).
Measured: 3 months
Fear
Fear assessment before, during, and after the PIK procedure in intervention and control groups.
Child Fear Scale: The Turkish psychometric properties of the scale adapted to pediatric patients as "Children's Fear Scale" by McMurty et al. (2011) were evaluated by Özalp Gerçeker et al. The CSA is a scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and evaluated between 0 and 4 (Özalp Gerçeker et al., 2018). It can be used by families and researchers to assess pain and anxiety before and during the procedure and is intended for children aged 5-10 years. In the Turkish reliability and validity study, the content validity index of the scale was found to be 0.89 (Özalp Gerçeker et al., 2018).
Measured: 3 months
Secondary outcomes (1)
Saticfaction
Satisfaction assessment after the PIK procedure in intervention and control groups.
Individuals were asked to give a score between 0-10 to determine their satisfaction. A score of "0" means "not at all satisfied", while a score of "10" means "very satisfied".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Oct 2023
- Primary completion1 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous CatheterizationStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya University Education and Research Hospital
- Responsible party
- Principal investigator, Ramazan BOZKURT, RN, MSc, PhD Candidate, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772259
- Sponsor's protocol ID
- E-16214662-050.01.04-236416-36
- Acronym
- PIK
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scupola A, Tiberti AC, Sasso P, Mastrocola A, Berarducci A, Bozzoni Pantaleoni F, Da Dalt S, Balestrazzi E. SD-OCT imaging of idiopathic macular holes with spontaneous closure. Ophthalmic Surg Lasers Imaging. 2012 Feb 23;43 Online:e14-7. doi: 10.3928/15428877-20120216-01.
PubMed 22356437Suman Kc S, Sharma P, Singh H, Bal C, Kumar R. Fibrous Dysplasia Mimicking Bone Metastasis on Both Bone Scintigraphy and (18)F-FDG PET-CT: Diagnostic Dilemma in a Patient with Breast Cancer. Nucl Med Mol Imaging. 2012 Dec;46(4):318-9. doi: 10.1007/s13139-012-0171-7. Epub 2012 Sep 15. No abstract available.
PubMed 24900084Shaik JA, Guram G. A Comparative Evaluation of Canine Retraction Using Ceramic Bracket and Ceramic Bracket with Metal Slot with Conventional Preadjusted Edgewise Appliance Bracket Systems: A Clinical Study. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):296-303. doi: 10.4103/jispcd.JISPCD_301_17. Epub 2018 Jul 18.
PubMed 30123760Otulakowski G, Kavanagh BP. Hydrogen sulfide in lung injury: therapeutic hope from a toxic gas? Anesthesiology. 2010 Jul;113(1):4-6. doi: 10.1097/ALN.0b013e3181dec00e. No abstract available.
PubMed 20574223Bozkurt R, Dogu O, Arsoy HEM, Ozdemir O. Comparing Nonpharmacological Interventions for Pain, Fear, and Satisfaction: A Randomized Controlled Trial. Pain Manag Nurs. 2026 Apr;27(2):e123-e132. doi: 10.1016/j.pmn.2025.09.004. Epub 2025 Oct 1.
PubMed 41038771
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Two Different Interventions on Pain and Fear in Peripheric Intravenous Catheterization in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06772259
- Acronym / sponsor ID
- PIK / E-16214662-050.01.04-236416-36
- Keywords
- pain, fear, children, distraction, palm stimulator, cartoon, peripheral intravenous, catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- Sakarya University Education and Research Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 13 Jan 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.
The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.
Hypotheses:
H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.
H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.
H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.
H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.
H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.
H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.
H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.
H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.
H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.
H10: PIK application time is different in the palm stimulator group compared to the control group.
H11: PIK application time is different in the cartoon group compared to the co
Detailed description
- To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application
- Measuring pain and fear levels by watching cartoons to children during PIK application
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palm stimulator group | Experimental | Device: Palm StimulatorThe Palm Stimulator is grasped in the palm during painful interventions and provides stimulation. Blunt protrusions around the apparatus provide tactile stimulation in the palm. The blunt protrusions have been found to reduce the pain perceived during the intervention by closing the pain gate in the spinal cortex by creating stimuli according to the gate control pain theory without penetrating the skin. The researchers who developed the apparatus were contacted via e-mail and permission was obtained for using the palm stimulator. In the study, the child held the palm stimulator in the palm during the PIK procedure, and the researcher evaluated pain and fear. After the PIK procedure was completed, the child was asked to release the apparatus from the palm. |
| Cartoon group | Experimental | Other: CartoonDistraction by watching cartoons is a promising, cost-effective, and non-pharmacologic technique to reduce pain in children undergoing painful procedures. The cartoon was selected by expert researchers from the pediatric field in the research team following the age and consciousness level of the children. A projection device was placed in the intervention room for data collection. The cartoon was projected on a blank wall in the intervention room. The cartoon was played in preparation for the PIK procedure, and children were allowed to watch it until it was completed. |
| Control gruup | No intervention | –In the control group, the routine application phase was performed. Age-appropriate children were seated in the blood sampling chair, and those who could not sit were placed on a stretcher, and PIK was performed. The parent was also taken to the intervention room during the procedure. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Voluntary participation in the study,
- Pediatric patients for whom written and verbal consent has been obtained from the parent,
- Pediatric patients for whom verbal consent was obtained,
- Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.
Key exclusion criteria (3 listed)
- Not volunteering to participate in the study,
- More than one PIK attempt,
- Children with a chronic, acute, or life-threatening illness.
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 |
|---|---|---|
| Palm StimulatorThe apparatus is 1.6 cm in diameter and 4 cm long. It has a cylindrical, non-slippery and easy-to-grasp structure for maximum contact with the palm | Device | Palm stimulator group |
| CartoonThe cartoon was projected on a blank wall in the intervention room with a projection device. The cartoon was played in preparation for the PIK procedure and children were allowed to watch it until the procedure was completed. | Other | Cartoon group |
Primary outcome
Pain Measurement
Time frame: 3 months
Before, during, and after the PIK procedure in intervention and control groups. Wong-Baker FACES Pain Scale: The scale used to diagnose pain in children was developed by Donna Lee Wong and Connie Morain Baker. The Wong-Baker Scale has been reported to be safe to use in children aged 3-18 who can verbally describe the level of pain. The scale includes facial expressions and numbers. The scale has a total of six facial expressions, and pain is graded between 0-10 (Wong \& Baker, 1988).
Fear
Time frame: 3 months
Fear assessment before, during, and after the PIK procedure in intervention and control groups. Child Fear Scale: The Turkish psychometric properties of the scale adapted to pediatric patients as "Children's Fear Scale" by McMurty et al. (2011) were evaluated by Özalp Gerçeker et al. The CSA is a scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and evaluated between 0 and 4 (Özalp Gerçeker et al., 2018). It can be used by families and researchers to assess pain and anxiety before and during the procedure and is intended for children aged 5-10 years. In the Turkish reliability and validity study, the content validity index of the scale was found to be 0.89 (Özalp Gerçeker et al., 2018).
1 secondary outcome
Saticfaction
Time frame: 3 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 13 Jan 2025.
- Results publication: PubMed 22356437Scupola A, Tiberti AC, Sasso P, Mastrocola A, Berarducci A, Bozzoni Pantaleoni F, Da Dalt S, Balestrazzi E. SD-OCT imaging of idiopathic macular holes with spontaneous closure. Ophthalmic Surg Lasers Imaging. 2012 Feb 23;43 Online:e14-7. doi: 10.3928/15428877-20120216-01.
- Results publication: PubMed 24900084Suman Kc S, Sharma P, Singh H, Bal C, Kumar R. Fibrous Dysplasia Mimicking Bone Metastasis on Both Bone Scintigraphy and (18)F-FDG PET-CT: Diagnostic Dilemma in a Patient with Breast Cancer. Nucl Med Mol Imaging. 2012 Dec;46(4):318-9. doi: 10.1007/s13139-012-0171-7. Epub 2012 Sep 15. No abstract available.
- Results publication: PubMed 30123760Shaik JA, Guram G. A Comparative Evaluation of Canine Retraction Using Ceramic Bracket and Ceramic Bracket with Metal Slot with Conventional Preadjusted Edgewise Appliance Bracket Systems: A Clinical Study. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):296-303. doi: 10.4103/jispcd.JISPCD_301_17. Epub 2018 Jul 18.
- Results publication: PubMed 20574223Otulakowski G, Kavanagh BP. Hydrogen sulfide in lung injury: therapeutic hope from a toxic gas? Anesthesiology. 2010 Jul;113(1):4-6. doi: 10.1097/ALN.0b013e3181dec00e. No abstract available.
- Derived from this study: PubMed 41038771Bozkurt R, Dogu O, Arsoy HEM, Ozdemir O. Comparing Nonpharmacological Interventions for Pain, Fear, and Satisfaction: A Randomized Controlled Trial. Pain Manag Nurs. 2026 Apr;27(2):e123-e132. doi: 10.1016/j.pmn.2025.09.004. Epub 2025 Oct 1.
- Individual participant dataSharing planned: Undecided
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 Palm Stimulator and Cartoon in people with To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization, run by Sakarya 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 4 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 13 Jan 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 Measurement (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT06772259, which also lists 5 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 13 Jan 2025.