Clinical trial NCT06562829: 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
Official title: Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Catheterization pain,Virtual reality technology ,PICC
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 174
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Children with severe cardiocerebral conditionsor critical coagulopathies.
* Known lidocaine allergies.
* Severe mental illness or cognitive impairment in patients.

Primary outcomes:
measure: Success rate of one puncture
timeFrame: Immediately after the end of the catheterization
Secondary outcomes:
measure: pain score
timeFrame: Immediately after the end of the catheterization
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Lijuan Feng
role: STUDY_DIRECTOR
References: