PainP-FLACCNCT07316036
Effect of Patterned Versus Plain Fixation on Pain During IV Therapy in Children
A study testing Patterned fixation tape and Plain fixation tape in people with Pain and Intravenous Therapy, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether using patterned fixation materials during intravenous therapy can reduce pain and affect physiological responses in children. Children who regularly receive intravenous therapy will take part in this study. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pain, Intravenous Therapy, Kronik hastalık
- What is being tested?
- Patterned fixation tape and Plain fixation tape
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 30 Jan 2026
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who regularly receive intravenous therapy for chronic conditions
- Ability of the child and parent/legal guardian to understand the study procedures
- Written informed consent obtained from the parent or legal guardian
- Assent obtained from the child when appropriate
Who cannot join
- - Presence of acute pain at the time of the procedure
- Diagnosis of conditions that may interfere with pain assessment, such as cerebral palsy or neuromuscular or peripheral nervous system disorders
- Requirement for more than one intravenous catheter insertion attempt during the procedure
- Withdrawal of consent by the child or parent/legal guardian
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan Üniversitesi
Konya, Meram, 42000
About this study
Official title: The Effect of Patterned Versus Plain Fixation Materials on Pain and Physiological Parameters in Children Receiving Intravenous Therapy: A Randomized Two-Period Crossover Trial
The goal of this clinical trial is to learn whether using patterned fixation materials during intravenous therapy can reduce pain and affect physiological responses in children.
Children who regularly receive intravenous therapy will take part in this study. Each participant will receive both patterned and plain fixation materials on different treatment days. Pain levels will be measured using an observation-based pain scale, and oxygen saturation and pulse rate will be recorded before and after the procedure.
Read the detailed description
This study is a randomized two-period crossover clinical trial designed to examine whether patterned fixation materials used during intravenous (IV) catheter placement reduce pain and influence physiological responses in children. The trial focuses on children who regularly receive IV therapy for chronic conditions and aims to compare two commonly used fixation materials: patterned fixation tape and plain fixation tape.
Participants are randomly assigned to one of two sequences. In Sequence AB, children receive the patterned fixation material during their first IV procedure and the plain fixation material during their next scheduled IV procedure. In Sequence BA, children receive the plain fixation material first and the patterned fixation material during their next procedure. A washout period of at least one week naturally occurs between visits because children attend the day treatment unit weekly or every three weeks for routine therapy. This interval is considered sufficient to prevent carry-over effects, as the intervention is a short-term non-pharmacological distraction method.
During each IV procedure, pain is assessed using the FLACC behavioral pain scale by two independent observers, and physiological parameters (oxygen saturation and pulse rate) are measured one minute before and one minute after the procedure. Each child serves as their own control, allowing within-participant comparisons between the patterned and plain fixation conditions.
The primary objective of the study is to determine whether patterned fixation materials lower pain scores compared with plain fixation materials. Secondary objectives include examining whether patterned fixation materials lead to more favorable physiological responses during IV catheter insertion.
- Conditions
- Pain, Intravenous Therapy, Kronik hastalık
- Being tested
- Patterned fixation tape, Plain fixation tape
- Keywords
- çocuklarda ağrı, desenli tespit malzemesi, non farmakolojik yöntemler, fizyolojik parametreler, ağrı puanı
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patterned fixation tapeDevice
Patterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure.
Plain fixation tapeDevice
Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.
| Study group | Role | What they receive |
|---|---|---|
| Patterned Fixation Material | Active comparator | Children receive intravenous catheter fixation using patterned fixation materials during routine intravenous therapy. Receives: Device: Patterned fixation tape; Device: Plain fixation tape |
| Plain Fixation Material | Active comparator | Children receive intravenous catheter fixation using standard plain fixation materials during routine intravenous therapy. Receives: Device: Patterned fixation tape; Device: Plain fixation tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity was assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational pain scale.
The total score ranges from 0 to 10, with higher scores indicating more severe pain.
Measured: Immediately after intravenous fixation during each study period
Secondary outcomes (2)
Physiological parameters, Spo2
Oxygen saturation (SpO₂) measured before and after intravenous fixation.
Measured: Immediately before and immediately after each intervention period
Physiological parameters, heart rate
heart rate measured before and after intravenous fixation.
Measured: Immediately before and immediately after each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Apr 2025
- Primary completion20 Dec 2025
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Crossover
- Model description
- This study uses a two-period randomized crossover design. Participants are assigned to one of two sequences (patterned fixation first, then plain; or plain fixation first, then patterned). Each child receives both interventions on different treatment days, serving as their own control.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müberra Ahsen Kalburcu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316036
- Sponsor's protocol ID
- NEU-IV-FLACC-2025
- Acronym
- P-FLACC
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves pediatric patients and includes sensitive clinical information. The informed consent forms and ethical approval for this thesis project do not allow the sharing of identifiable or individual-level data with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patterned Versus Plain Fixation Materials on Pain and Physiological Parameters in Children Receiving Intravenous Therapy: A Randomized Two-Period Crossover Trial
- ClinicalTrials.gov ID
- NCT07316036
- Acronym / sponsor ID
- P-FLACC / NEU-IV-FLACC-2025
- Conditions
- Pain, Intravenous Therapy, Kronik hastalık
- Keywords
- çocuklarda ağrı, desenli tespit malzemesi, non farmakolojik yöntemler, fizyolojik parametreler, ağrı puanı
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 5 Jan 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 goal of this clinical trial is to learn whether using patterned fixation materials during intravenous therapy can reduce pain and affect physiological responses in children.
Children who regularly receive intravenous therapy will take part in this study. Each participant will receive both patterned and plain fixation materials on different treatment days. Pain levels will be measured using an observation-based pain scale, and oxygen saturation and pulse rate will be recorded before and after the procedure.
Detailed description
This study is a randomized two-period crossover clinical trial designed to examine whether patterned fixation materials used during intravenous (IV) catheter placement reduce pain and influence physiological responses in children. The trial focuses on children who regularly receive IV therapy for chronic conditions and aims to compare two commonly used fixation materials: patterned fixation tape and plain fixation tape.
Participants are randomly assigned to one of two sequences. In Sequence AB, children receive the patterned fixation material during their first IV procedure and the plain fixation material during their next scheduled IV procedure. In Sequence BA, children receive the plain fixation material first and the patterned fixation material during their next procedure. A washout period of at least one week naturally occurs between visits because children attend the day treatment unit weekly or every three weeks for routine therapy. This interval is considered sufficient to prevent carry-over effects, as the intervention is a short-term non-pharmacological distraction method.
During each IV procedure, pain is assessed using the FLACC behavioral pain scale by two independent observers, and physiological parameters (oxygen saturation and pulse rate) are measured one minute before and one minute after the procedure. Each child serves as their own control, allowing within-participant comparisons between the patterned and plain fixation conditions.
The primary objective of the study is to determine whether patterned fixation materials lower pain scores compared with plain fixation materials. Secondary objectives include examining whether patterned fixation materials lead to more favorable physiological responses during IV catheter insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a two-period randomized crossover design. Participants are assigned to one of two sequences (patterned fixation first, then plain; or plain fixation first, then patterned). Each child receives both interventions on different treatment days, serving as their own control.
| Arm | Type | Receives |
|---|---|---|
| Patterned Fixation Material | Active comparator | Device: Patterned fixation tape, Device: Plain fixation tapeChildren receive intravenous catheter fixation using patterned fixation materials during routine intravenous therapy. |
| Plain Fixation Material | Active comparator | Device: Patterned fixation tape, Device: Plain fixation tapeChildren receive intravenous catheter fixation using standard plain fixation materials during routine intravenous therapy. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who regularly receive intravenous therapy for chronic conditions
- Ability of the child and parent/legal guardian to understand the study procedures
- Written informed consent obtained from the parent or legal guardian
- Assent obtained from the child when appropriate
Key exclusion criteria (4 listed)
- - Presence of acute pain at the time of the procedure
- Diagnosis of conditions that may interfere with pain assessment, such as cerebral palsy or neuromuscular or peripheral nervous system disorders
- Requirement for more than one intravenous catheter insertion attempt during the procedure
- Withdrawal of consent by the child or parent/legal guardian
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 |
|---|---|---|
| Patterned fixation tapePatterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure. | Device | Patterned Fixation Material, Plain Fixation Material |
| Plain fixation tapePlain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials. | Device | Patterned Fixation Material, Plain Fixation Material |
Primary outcome
Pain intensity
Time frame: Immediately after intravenous fixation during each study period
Pain intensity was assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational pain scale. The total score ranges from 0 to 10, with higher scores indicating more severe pain.
2 secondary outcomes
Physiological parameters, Spo2
Time frame: Immediately before and immediately after each intervention period
Physiological parameters, heart rate
Time frame: Immediately before and immediately after each intervention period
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 5 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves pediatric patients and includes sensitive clinical information. The informed consent forms and ethical approval for this thesis project do not allow the sharing of identifiable or individual-level data with external researchers.
Related trials for Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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 Patterned fixation tape and Plain fixation tape in people with Pain and Intravenous Therapy, run by Necmettin Erbakan 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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 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?
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 intensity (time frame: Immediately after intravenous fixation during each study period). 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 5 Jan 2026.