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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Catheterization, Peripheral

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality technology

Device

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 injection

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. pain score

    Time frame: Immediately after the end of the catheterization

    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.

Sponsors and collaborators

Lead sponsor

Qi Yu

Other

Registry information

Official study title

Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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