Catheterization, PeripheralNCT06562829
The Main Content of This Study is to Use Virtual Reality Technology Combined With Local Anesthesia With Lidocaine Injection at Different Times to Reduce the Pain of PICC in School-age Children
A study testing Virtual reality technology and different timing of lidocaine injection in people with Catheterization, Peripheral, run by Qi Yu at 1 site in China.
Trial summary
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- Virtual reality technology and different timing of lidocaine injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2020to 28 May 2021
- 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
- No healthy volunteers
- Child
Who may be able to join
- Participants aged between 6 and 12 years.
- Undergoing their inaugural ultrasound-guided PICC insertion in an up.
- Voluntarper limby participation and informed consent by parents or guardians.
Who cannot join
- Children with severe cardiocerebral conditionsor critical coagulopathies.
- Known lidocaine allergies.
- Severe mental illness or cognitive impairment in patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided into three groups A, B, c, group A in ultrasound guided by PICC placement; Group B and group C adopt VR intervention, and 5 min before the beginning of the next surgery using VR equipment. Group B was anesthetized after the needle was placed into the guide wire, and group C was anesthetized before the needle was placed into the guide wire.
Read the detailed description
This study investigated the effect of VR combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter (PICC) insertion, aiming to improve one-needle puncture success rate, reduce pain, reduce fear, improve compliance and catheterization time.
From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized after the puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire.The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three groups. A sample size and power analysis were conducted to determine the sample size required.The investigators assumed a medium effect size (f2 = 0.25) of the active VR. Using 2 tails and alpha = .05, a fixed-effect linear regression model would offer power greater than 0.80 with a total sample size of 159 children. To ensure adequate power, the investigators planned to recruit 56 participants for each group. Three groups were all operated by PICC specialist nurses, and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines.
- Conditions
- Catheterization, Peripheral
- Being tested
- Virtual reality technology, different timing of lidocaine injection
- Keywords
- Catheterization pain,Virtual reality technology ,PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality technologyDevice
Group B (Lidocaine injection after puncture): ①Download games in the VR headset in advance,The games last approximately 10-15 minutes. Games were selected based on children's preferences, and the VR headset was worn in the optimal state 5 minutes before catheterization.②Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter.
different timing of lidocaine injectionOther
Group C (Lidocaine injection before puncture): Steps①was the same as in group B, After disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Catheters were implanted according to PICC routine procedures:Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter |
| Group B | Experimental | The virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr device,Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter Receives: Device: Virtual reality technology |
| Group C | Experimental | The virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr devicea and disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length Receives: Device: Virtual reality technology; Other: different timing of lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of one puncture
The blood vessel was entered by one puncture, and there was no other operation to explore the subcutaneous vessel, pull out the needle or change the puncture site
Measured: Immediately after the end of the catheterization
Secondary outcomes (1)
pain score
Assessed using the Visual Analogue Scale ranging from "no pain" (0) to "the most severe pain" (10). A higher score indicates a greater degree of pain.
Measured: Immediately after the end of the catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start21 May 2020
- Primary completion17 Apr 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized afterthe puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire. The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qi Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi Yu, Tongji Hospital
- Investigators
- Lijuan Feng, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562829
- Sponsor's protocol ID
- TJ-C20200505
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement
- ClinicalTrials.gov ID
- NCT06562829
- Acronym / sponsor ID
- TJ-C20200505
- Conditions
- Catheterization, Peripheral
- Keywords
- Catheterization pain,Virtual reality technology ,PICC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Qi YuUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 20 Aug 2024 (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.
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided into three groups A, B, c, group A in ultrasound guided by PICC placement; Group B and group C adopt VR intervention, and 5 min before the beginning of the next surgery using VR equipment. Group B was anesthetized after the needle was placed into the guide wire, and group C was anesthetized before the needle was placed into the guide wire.
Detailed description
This study investigated the effect of VR combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter (PICC) insertion, aiming to improve one-needle puncture success rate, reduce pain, reduce fear, improve compliance and catheterization time.
From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized after the puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire.The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three groups. A sample size and power analysis were conducted to determine the sample size required.The investigators assumed a medium effect size (f2 = 0.25) of the active VR. Using 2 tails and alpha = .05, a fixed-effect linear regression model would offer power greater than 0.80 with a total sample size of 159 children. To ensure adequate power, the investigators planned to recruit 56 participants for each group. Three groups were all operated by PICC specialist nurses, and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized afterthe puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire. The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three group
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Catheters were implanted according to PICC routine procedures:Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter |
| Group B | Experimental | Device: Virtual reality technologyThe virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr device,Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter |
| Group C | Experimental | Device: Virtual reality technology, Other: different timing of lidocaine injectionThe virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr devicea and disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants aged between 6 and 12 years.
- Undergoing their inaugural ultrasound-guided PICC insertion in an up.
- Voluntarper limby participation and informed consent by parents or guardians.
Key exclusion criteria (3 listed)
- Children with severe cardiocerebral conditionsor critical coagulopathies.
- Known lidocaine allergies.
- Severe mental illness or cognitive impairment in patients.
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 |
|---|---|---|
| Virtual reality technologyGroup B (Lidocaine injection after puncture): ①Download games in the VR headset in advance,The games last approximately 10-15 minutes. Games were selected based on children's preferences, and the VR headset was worn in the optimal state 5 minutes before catheterization.②Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter. | Device | Group B, Group C |
| different timing of lidocaine injectionGroup C (Lidocaine injection before puncture): Steps①was the same as in group B, After disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length. | Other | Group C |
Primary outcome
Success rate of one puncture
Time frame: Immediately after the end of the catheterization
The blood vessel was entered by one puncture, and there was no other operation to explore the subcutaneous vessel, pull out the needle or change the puncture site
1 secondary outcome
pain score
Time frame: Immediately after the end of the 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 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Catheterization, Peripheral
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety
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.
Lijuan Feng study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality technology and different timing of lidocaine injection in people with Catheterization, Peripheral, run by Qi Yu at 1 site in China.
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 3 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 21 Aug 2024. 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 China. 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?
Success rate of one puncture (time frame: Immediately after the end of the 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 21 Aug 2024.