Venous Puncture PainNCT06089889
Investigating the Impact of Ice Application on the Venous Puncture Pain in the Pediatric Population
A study testing ice application in people with Venous Puncture Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
the goal of this RCT is: "To evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain among children aged 5 to 7 years.". An (RCT) will be conducted, involving 94 children, a non-probability convenience sampling will be used and children will randomly assign to two… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Puncture Pain
- What is being tested?
- ice application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2024to 7 Jun 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children within age group of 5-7 years
- Children who were advised to undergo venous puncture in the pediatric ward
Who cannot join
- Chronically ill
- Mentally handicapped
- Already having local anesthesia at the venous puncture site
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
THQ hospital muridke and DHQ hospital sheikhupura
Lahore, Pakistan
About this study
the goal of this RCT is: "To evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain among children aged 5 to 7 years.".
An (RCT) will be conducted, involving 94 children, a non-probability convenience sampling will be used and children will randomly assign to two groups by lottery method. One group will receive ice application as an intervention, while other group will be control group, having no ice application.
Read the detailed description
Children often undergo venous punctures in wards and emergency rooms, a procedure that is both painful and distressing for both children and their parents. When pain is not effectively managed, it can lead to fear, anxiety, uncooperative behavior, unsuccessful attempts, prolonged procedure duration, and overall dissatisfaction with the care provided. Various methods, both pharmacological and non-pharmacological, can help reduce pain during venous puncture, but most of these preparations are not feasible in urgent situations due to their time-consuming nature. The aim of this study is to evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain in children. It is hypothesized that there is a significant difference in the pain intensity/score among children in the intervention group (ice application) and the control group (without ice application).
The rationale of this study is to find a cost-effective method for reducing pain during IV puncture, minimizing hospitalization costs for children, and alleviating their fear of pain. A randomized controlled trial (RCT) will be conducted, involving 94 children. Non-probability convenience sampling will be used, and children will be randomly assigned to two groups using the lottery method. One group will receive ice application as an intervention, while the other group will serve as the control group. The effectiveness of this approach will be assessed through a comparative analysis of these two groups. The study will span a duration of 4-5 months, starting after the synopsis receives approval. The target population for the study will be children aged 5 to 7 years. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale. Data will be analyzed using SPSS version 24. Descriptive statistics (frequency, percentage) will be used to describe the characteristics of the study population. The Chi-square test will be used to examine the demographic information of the two groups. Independent t-tests will be used to compare the means of both groups after intervention. The significance level of the tests will be considered at a p-value < 0.05. The anticipated findings of this study lie in its comprehensive analysis of this methodology to determine the most economically feasible non-pharmacological approach. By focusing on resource-limited hospitals in Pakistan, the study aims to swiftly identify a method that can be readily implemented, effectively cutting down hospitalization costs for children while also addressing their pain-related issues. This research not only establishes a crucial benchmark in evidence collection but also paves the way for addressing pain-related challenges linked to venipuncture in pediatric patients, offering substantial benefits in the long run
- Conditions
- Venous Puncture Pain
- Being tested
- ice application, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice applicationOther
- Group 1 will undergo the first intervention, which involves the application of ice.
- Ice pack will be applied on the site of venipuncture prior to intravenous procedures for 3 minutes.
- The procedure of venous puncture will be carried out in accordance with established standard operating procedures (SOPs).
- pain will be assessed through Wong baker Faces Pain scale immediate after venous puncture procedure. after taking consent from parents/guardians, the pain response of children will be video taped for the purpose of objectively assessing the pain. and data will be kept confidential.
control groupOther
- Group 2 will be control group, which involves no ice application
- The venipuncture procedure will be carried out according to established standard operating procedures (SOPs), pain will be assessed by Wong Baker Faces Pain Scale immediate after venous puncture procedure.
After obtaining consent from parents/guardians, the pain responses of children will be videotaped for the purpose of objectively assessing pain, and the data will be kept confidential.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will receive ice application as intervention 3 minutes before venous puncture. Receives: Other: ice application |
| Group 2 | Experimental | Group 2 will be control group, without ice application. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
venous puncture pain
pain will be measured by Wong baker faces pain scale after venipuncture.Donnie Wong and Connie Baker developed The Wong-Baker Faces Pain Rating Scale in 1983. They research that children had difficulty rating their pain with numbers yet responded well to facial expressions. Consequently, they developed the scale to help children better communicate their pain. The Wong-Baker Faces Pain Rating Scale is a tool that aids individuals in expressing their physical pain. It employs facial expressions, numerical values, and descriptive words, allowing for varied ways to convey pain intensity. This self-assessment method encompasses a range of six faces, from a smiling face denoting "no hurt" (0) to a tearful face representing "hurts worst" (10), enabling effective communication of pain severity.
The Wong-Baker Faces Pain Scale has been extensively studied in literature, with its reliability and validity having already been established for children aged 3 to 18 years
Measured: pain will be assessed immediate after venous puncture procedure, and data collection will take 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start12 Jul 2024
- Primary completion30 Nov 2024
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Puncture PainStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be allocated in two groups by randomization (lottery method). one group will be intervention group and other group would be control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidra Sultan, University of Health Sciences Lahore
- Investigators
- sidra sultan, ms nursing, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089889
- Sponsor's protocol ID
- VPP RCT 001
- Status last verified
- May 2026
- First submitted
- 3 Oct 2023
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Ice Application on the Venous Puncture Pain in the Pediatric Population
- ClinicalTrials.gov ID
- NCT06089889
- Acronym / sponsor ID
- VPP RCT 001
- Conditions
- Venous Puncture Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 19 Oct 2023 (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 RCT is: "To evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain among children aged 5 to 7 years.".
An (RCT) will be conducted, involving 94 children, a non-probability convenience sampling will be used and children will randomly assign to two groups by lottery method. One group will receive ice application as an intervention, while other group will be control group, having no ice application.
Detailed description
Children often undergo venous punctures in wards and emergency rooms, a procedure that is both painful and distressing for both children and their parents. When pain is not effectively managed, it can lead to fear, anxiety, uncooperative behavior, unsuccessful attempts, prolonged procedure duration, and overall dissatisfaction with the care provided. Various methods, both pharmacological and non-pharmacological, can help reduce pain during venous puncture, but most of these preparations are not feasible in urgent situations due to their time-consuming nature. The aim of this study is to evaluate the effectiveness of a non-pharmacological method (ice application) in reducing venous puncture pain in children. It is hypothesized that there is a significant difference in the pain intensity/score among children in the intervention group (ice application) and the control group (without ice application).
The rationale of this study is to find a cost-effective method for reducing pain during IV puncture, minimizing hospitalization costs for children, and alleviating their fear of pain. A randomized controlled trial (RCT) will be conducted, involving 94 children. Non-probability convenience sampling will be used, and children will be randomly assigned to two groups using the lottery method. One group will receive ice application as an intervention, while the other group will serve as the control group. The effectiveness of this approach will be assessed through a comparative analysis of these two groups. The study will span a duration of 4-5 months, starting after the synopsis receives approval. The target population for the study will be children aged 5 to 7 years. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale. Data will be analyzed using SPSS version 24. Descriptive statistics (frequency, percentage) will be used to describe the characteristics of the study population. The Chi-square test will be used to examine the demographic information of the two groups. Independent t-tests will be used to compare the means of both groups after intervention. The significance level of the tests will be considered at a p-value < 0.05. The anticipated findings of this study lie in its comprehensive analysis of this methodology to determine the most economically feasible non-pharmacological approach. By focusing on resource-limited hospitals in Pakistan, the study aims to swiftly identify a method that can be readily implemented, effectively cutting down hospitalization costs for children while also addressing their pain-related issues. This research not only establishes a crucial benchmark in evidence collection but also paves the way for addressing pain-related challenges linked to venipuncture in pediatric patients, offering substantial benefits in the long run
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be allocated in two groups by randomization (lottery method). one group will be intervention group and other group would be control group
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: ice applicationGroup 1 will receive ice application as intervention 3 minutes before venous puncture. |
| Group 2 | Experimental | Other: control groupGroup 2 will be control group, without ice application. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children within age group of 5-7 years
- Children who were advised to undergo venous puncture in the pediatric ward
Key exclusion criteria (3 listed)
- Chronically ill
- Mentally handicapped
- Already having local anesthesia at the venous puncture site
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 |
|---|---|---|
| ice application* Group 1 will undergo the first intervention, which involves the application of ice. * Ice pack will be applied on the site of venipuncture prior to intravenous procedures for 3 minutes. * The procedure of venous puncture will be carried out in accordance with established standard operating procedures (SOPs). * pain will be assessed through Wong baker Faces Pain scale immediate after venous puncture procedure. after taking consent from parents/guardians, the pain response of children will be video taped for the purpose of objectively assessing the pain. and data will be kept confidential. | Other | Group 1 |
| control group* Group 2 will be control group, which involves no ice application * The venipuncture procedure will be carried out according to established standard operating procedures (SOPs), pain will be assessed by Wong Baker Faces Pain Scale immediate after venous puncture procedure. After obtaining consent from parents/guardians, the pain responses of children will be videotaped for the purpose of objectively assessing pain, and the data will be kept confidential. | Other | Group 2 |
Primary outcome
venous puncture pain
Time frame: pain will be assessed immediate after venous puncture procedure, and data collection will take 2 months
pain will be measured by Wong baker faces pain scale after venipuncture.Donnie Wong and Connie Baker developed The Wong-Baker Faces Pain Rating Scale in 1983. They research that children had difficulty rating their pain with numbers yet responded well to facial expressions. Consequently, they developed the scale to help children better communicate their pain. The Wong-Baker Faces Pain Rating Scale is a tool that aids individuals in expressing their physical pain. It employs facial expressions, numerical values, and descriptive words, allowing for varied ways to convey pain intensity. This self-assessment method encompasses a range of six faces, from a smiling face denoting "no hurt" (0) to a tearful face representing "hurts worst" (10), enabling effective communication of pain severity. The Wong-Baker Faces Pain Scale has been extensively studied in literature, with its reliability and validity having already been established for children aged 3 to 18 years
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 11 May 2026.
- Individual participant dataSharing planned: No
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.
sidra sultan, ms nursing principal investigator
University of Health Sciences Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ice application in people with Venous Puncture Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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 Pakistan. 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?
venous puncture pain (time frame: pain will be assessed immediate after venous puncture procedure, and data collection will take 2 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 11 May 2026.