Peripheral Intravenous CatheterizationNCT07909330
Effect of Topical Black Pepper Oil on Pain and Vein Visibility During Peripheral Intravenous Catheterization in Children
A study testing Topical Black Pepper Essential Oil Preparation in people with Peripheral Intravenous Catheterization, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was designed to evaluate the effects of topical black pepper (Piper nigrum L.) essential oil on vein visibility, palpability, and pain in children aged 7-12 years undergoing peripheral intravenous catheterization (PIVC) in a pediatric emergency department. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Peripheral Intravenous Catheterization
- What is being tested?
- Topical Black Pepper Essential Oil Preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 12 Mar 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years.
- Requiring peripheral intravenous catheterization in the pediatric emergency department.
- No physical, cognitive, or mental health condition preventing communication or participation in pain assessment.
- Ability of the child and parent to communicate in Turkish.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the child
Who cannot join
- - Coagulation disorders.
- Medical conditions significantly affecting nutritional status.
- Hematological or oncological diseases.
- Congenital, genetic, or neurological diseases.
- Conditions affecting skin integrity or mobility of the upper extremities.
- Known allergy or hypersensitivity to black pepper essential oil.
- Body temperature above 37.5°C.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Istanbul, 34093
About this study
Official title: The Effect of Topical Black Pepper Oil Applied Before Peripheral Intravenous Catheterization on Procedural Pain and Vein Visibility in Children Aged 7-12 Years Presenting to the Pediatric Emergency Department: A Randomized Controlled Trial
This randomized controlled trial was designed to evaluate the effects of topical black pepper (Piper nigrum L.) essential oil on vein visibility, palpability, and pain in children aged 7-12 years undergoing peripheral intravenous catheterization (PIVC) in a pediatric emergency department.
The study was conducted between March 2024 and March 2025 at the Pediatric Emergency Department of Istanbul University, Istanbul Faculty of Medicine, Türkiye. A total of 80 children were allocated to an intervention group (n=40) or a control group (n=40) using computer-generated simple randomization.
Read more
Children in the intervention group received 3 mL of a topical preparation containing 20% black pepper essential oil and 80% Aloe vera, applied to the planned catheterization site using a roll-on applicator. After a 10-minute waiting period, vein visibility and palpability were reassessed. Children in the control group received routine care without an additional topical intervention.
The primary outcome was vein visibility and palpability, assessed before the intervention and approximately 10 minutes later using the Vein Visibility and Palpability Score. The secondary outcome was pain intensity, assessed using the Visual Analogue Scale (VAS) before catheterization and immediately after completion of the procedure.
Vein assessments were performed independently by two outcome assessors who were not informed of group allocation. The study aimed to investigate whether topical black pepper essential oil could improve vein prominence and reduce reported pain in children undergoing peripheral intravenous catheterization.
Read the detailed description
Study Design and Setting
This study was a two-arm, parallel-group, assessor-blinded randomized controlled trial with a 1:1 allocation ratio. It was conducted between March 2024 and March 2025 in the Pediatric Emergency Department of Istanbul University, Istanbul Faculty of Medicine, Türkiye.
Participants
The study included 80 children aged 7-12 years who required peripheral intravenous catheterization (PIVC). Eligibility criteria included the need for PIVC, the ability to communicate and participate in pain assessment, Turkish language proficiency of the child and parent, and willingness to participate.
Exclusion criteria included coagulation disorders, significant nutritional conditions, hematological or oncological diseases, congenital, genetic or neurological diseases, upper-extremity conditions affecting skin integrity or mobility, known allergy or hypersensitivity to black pepper oil, and body temperature above 37.5°C.
Randomization and Blinding
Participants were allocated to the intervention or control group using computer-generated simple randomization. The allocation sequence was prepared using IBM SPSS Statistics and maintained by an independent nurse who was not involved in participant recruitment, intervention delivery, or outcome assessment.
Due to the characteristic odor and application method of the topical preparation, participants and the nurse administering the intervention were not blinded. However, vein visibility and palpability were independently assessed by two observers who were not informed of group allocation.
Intervention Group
Children allocated to the intervention group received a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera gel.
A total of 3 mL of the preparation was applied to the planned PIVC insertion site using a roll-on applicator with 12 application strokes. A 10-minute waiting period was observed before reassessment of vein visibility and palpability.
During this period, the application site was monitored for local adverse reactions, including redness, burning, irritation, and allergic reactions.
Following the second vein assessment, standard skin antisepsis was performed and peripheral intravenous catheterization was carried out.
Control Group
Children allocated to the control group received routine PIVC care without an additional topical intervention.
Vein visibility and palpability were assessed at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
All PIVC procedures in both groups were performed by the same experienced nurse using peripheral intravenous catheters of the same brand and size.
Outcome Measures
The primary outcome was vein visibility and palpability, measured using the Vein Visibility and Palpability Score. This three-category ordinal scale classifies veins as:
0 = Neither visible nor palpable.
- = Visible or palpable.
- = Both visible and palpable.
Assessments were conducted at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
The secondary outcome was pain intensity, measured using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Pain was assessed before catheterization and immediately after completion of the procedure. Baseline pain represented the child's existing pain level before catheterization. Pain specifically experienced at the moment of needle insertion was not measured separately.
Statistical Analysis
Data were analyzed using IBM SPSS Statistics. Generalized estimating equations (GEE) were used to examine group, time, and group-by-time effects. An ordinal cumulative-logit model was used for vein visibility and a Gaussian model with an identity link for pain intensity.
Inter-rater agreement was evaluated using Cohen's kappa coefficient. Additional sensitivity analyses were performed, and Holm correction was applied for multiple comparisons where appropriate.
- Conditions
- Peripheral Intravenous Catheterization
- Being tested
- Topical Black Pepper Essential Oil Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Black Pepper Essential Oil PreparationOther
Children in the intervention group received 3 mL of a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera. The preparation was applied to the planned peripheral intravenous catheterization site using a roll-on applicator with 12 application strokes. After a 10-minute waiting period, vein visibility and palpability were assessed before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were subsequently performed.
| Study group | Role | What they receive |
|---|---|---|
| Black Pepper Essential Oil Group | Experimental | Children assigned to this group received 3 mL of a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera, applied to the planned peripheral intravenous catheterization site using a roll-on applicator with 12 application strokes. After a 10-minute waiting period, vein visibility and palpability were assessed before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were then performed. Receives: Other: Topical Black Pepper Essential Oil Preparation |
| Routine Care Group | No intervention | Children assigned to the control group received routine peripheral intravenous catheterization care without topical black pepper essential oil or Aloe vera application. Vein visibility and palpability were assessed at baseline and approximately 10 minutes later, before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were then performed by the same experienced nurse as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vein Visibility and Palpability
Description Vein visibility and palpability were assessed using the Vein Visibility and Palpability Score, a three-category ordinal scale ranging from 0 to 2. A score of 0 indicates that the vein is neither visible nor palpable; 1 indicates that the vein is either visible or palpable; and 2 indicates that the vein is both visible and palpable. Higher scores indicate greater vein visibility and palpability. Assessments were performed independently by two blinded outcome assessors at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
Measured: At baseline and approximately 10 minutes later, before catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start12 Mar 2024
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous CatheterizationStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a two-arm, parallel-group, assessor-blinded randomized controlled design with a 1:1 allocation ratio. Eighty children aged 7-12 years undergoing peripheral intravenous catheterization were randomly assigned to an intervention group (n=40) or a control group (n=40) using a computer-generated randomization sequence created with IBM SPSS Statistics. The intervention group received 3 mL of a topical preparation containing 20% black pepper essential oil and 80% Aloe vera, whereas the control group received routine care. Vein visibility and palpability were assessed by two blinded outcome assessors. Participants and the administering nurse were not blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK SÖNMEZ SAĞLIK, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909330
- Sponsor's protocol ID
- IU-BPO-PIVC-2026-01
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Black Pepper Oil Applied Before Peripheral Intravenous Catheterization on Procedural Pain and Vein Visibility in Children Aged 7-12 Years Presenting to the Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07909330
- Acronym / sponsor ID
- IU-BPO-PIVC-2026-01
- Conditions
- Peripheral Intravenous Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 2 Nov 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.
This randomized controlled trial was designed to evaluate the effects of topical black pepper (Piper nigrum L.) essential oil on vein visibility, palpability, and pain in children aged 7-12 years undergoing peripheral intravenous catheterization (PIVC) in a pediatric emergency department.
The study was conducted between March 2024 and March 2025 at the Pediatric Emergency Department of Istanbul University, Istanbul Faculty of Medicine, Türkiye. A total of 80 children were allocated to an intervention group (n=40) or a control group (n=40) using computer-generated simple randomization.
Children in the intervention group received 3 mL of a topical preparation containing 20% black pepper essential oil and 80% Aloe vera, applied to the planned catheterization site using a roll-on applicator. After a 10-minute waiting period, vein visibility and palpability were reassessed. Children in the control group received routine care without an additional topical intervention.
The primary outcome was vein visibility and palpability, assessed before the intervention and approximately 10 minutes later using the Vein Visibility and Palpability Score. The secondary outcome was pain intensity, assessed using the Visual Analogue Scale (VAS) before catheterization and immediately after completion of the procedure.
Vein assessments were performed independently by two outcome assessors who were not informed of group allocation. The study aimed to investigate whether topical black pepper essential oil could improve vein prominence and reduce reported pain in children undergoing peripheral intravenous catheterization.
Detailed description
Study Design and Setting
This study was a two-arm, parallel-group, assessor-blinded randomized controlled trial with a 1:1 allocation ratio. It was conducted between March 2024 and March 2025 in the Pediatric Emergency Department of Istanbul University, Istanbul Faculty of Medicine, Türkiye.
Participants
The study included 80 children aged 7-12 years who required peripheral intravenous catheterization (PIVC). Eligibility criteria included the need for PIVC, the ability to communicate and participate in pain assessment, Turkish language proficiency of the child and parent, and willingness to participate.
Exclusion criteria included coagulation disorders, significant nutritional conditions, hematological or oncological diseases, congenital, genetic or neurological diseases, upper-extremity conditions affecting skin integrity or mobility, known allergy or hypersensitivity to black pepper oil, and body temperature above 37.5°C.
Randomization and Blinding
Participants were allocated to the intervention or control group using computer-generated simple randomization. The allocation sequence was prepared using IBM SPSS Statistics and maintained by an independent nurse who was not involved in participant recruitment, intervention delivery, or outcome assessment.
Due to the characteristic odor and application method of the topical preparation, participants and the nurse administering the intervention were not blinded. However, vein visibility and palpability were independently assessed by two observers who were not informed of group allocation.
Intervention Group
Children allocated to the intervention group received a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera gel.
A total of 3 mL of the preparation was applied to the planned PIVC insertion site using a roll-on applicator with 12 application strokes. A 10-minute waiting period was observed before reassessment of vein visibility and palpability.
During this period, the application site was monitored for local adverse reactions, including redness, burning, irritation, and allergic reactions.
Following the second vein assessment, standard skin antisepsis was performed and peripheral intravenous catheterization was carried out.
Control Group
Children allocated to the control group received routine PIVC care without an additional topical intervention.
Vein visibility and palpability were assessed at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
All PIVC procedures in both groups were performed by the same experienced nurse using peripheral intravenous catheters of the same brand and size.
Outcome Measures
The primary outcome was vein visibility and palpability, measured using the Vein Visibility and Palpability Score. This three-category ordinal scale classifies veins as:
0 = Neither visible nor palpable.
- = Visible or palpable.
- = Both visible and palpable.
Assessments were conducted at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
The secondary outcome was pain intensity, measured using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Pain was assessed before catheterization and immediately after completion of the procedure. Baseline pain represented the child's existing pain level before catheterization. Pain specifically experienced at the moment of needle insertion was not measured separately.
Statistical Analysis
Data were analyzed using IBM SPSS Statistics. Generalized estimating equations (GEE) were used to examine group, time, and group-by-time effects. An ordinal cumulative-logit model was used for vein visibility and a Gaussian model with an identity link for pain intensity.
Inter-rater agreement was evaluated using Cohen's kappa coefficient. Additional sensitivity analyses were performed, and Holm correction was applied for multiple comparisons where appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a two-arm, parallel-group, assessor-blinded randomized controlled design with a 1:1 allocation ratio. Eighty children aged 7-12 years undergoing peripheral intravenous catheterization were randomly assigned to an intervention group (n=40) or a control group (n=40) using a computer-generated randomization sequence created with IBM SPSS Statistics. The intervention group received 3 mL of a topical preparation containing 20% black pepper essential oil and 80% Aloe vera, whereas the control group received routine care. Vein visibility and palpability were assessed by two blinded outcome assessors. Participants and the administering nurse were not blinded.
| Arm | Type | Receives |
|---|---|---|
| Black Pepper Essential Oil Group | Experimental | Other: Topical Black Pepper Essential Oil PreparationChildren assigned to this group received 3 mL of a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera, applied to the planned peripheral intravenous catheterization site using a roll-on applicator with 12 application strokes. After a 10-minute waiting period, vein visibility and palpability were assessed before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were then performed. |
| Routine Care Group | No intervention | –Children assigned to the control group received routine peripheral intravenous catheterization care without topical black pepper essential oil or Aloe vera application. Vein visibility and palpability were assessed at baseline and approximately 10 minutes later, before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were then performed by the same experienced nurse as in the intervention group. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 7-12 years.
- Requiring peripheral intravenous catheterization in the pediatric emergency department.
- No physical, cognitive, or mental health condition preventing communication or participation in pain assessment.
- Ability of the child and parent to communicate in Turkish.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the child
Key exclusion criteria (7 listed)
- - Coagulation disorders.
- Medical conditions significantly affecting nutritional status.
- Hematological or oncological diseases.
- Congenital, genetic, or neurological diseases.
- Conditions affecting skin integrity or mobility of the upper extremities.
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 |
|---|---|---|
| Topical Black Pepper Essential Oil PreparationChildren in the intervention group received 3 mL of a topical preparation containing 20% black pepper (Piper nigrum L.) essential oil and 80% Aloe vera. The preparation was applied to the planned peripheral intravenous catheterization site using a roll-on applicator with 12 application strokes. After a 10-minute waiting period, vein visibility and palpability were assessed before tourniquet application. Standard skin antisepsis and peripheral intravenous catheterization were subsequently performed. | Other | Black Pepper Essential Oil Group |
Primary outcome
Change in Vein Visibility and Palpability
Time frame: At baseline and approximately 10 minutes later, before catheterization
Description Vein visibility and palpability were assessed using the Vein Visibility and Palpability Score, a three-category ordinal scale ranging from 0 to 2. A score of 0 indicates that the vein is neither visible nor palpable; 1 indicates that the vein is either visible or palpable; and 2 indicates that the vein is both visible and palpable. Higher scores indicate greater vein visibility and palpability. Assessments were performed independently by two blinded outcome assessors at baseline and approximately 10 minutes later, before tourniquet application and catheterization.
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 2 Nov 2026.
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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.
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 Topical Black Pepper Essential Oil Preparation in people with Peripheral Intravenous Catheterization, run by Istanbul 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 5 inclusion and 7 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 2 Nov 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?
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?
Change in Vein Visibility and Palpability (time frame: At baseline and approximately 10 minutes later, before catheterization). 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 2 Nov 2026.