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

NCT06562829 | Completed

• 1 other identifier: TJ-C20200505
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization, Peripheral

Keywords

Catheterization pain,Virtual reality technology ,PICC

Outcome Measures

Primary Outcomes (1)

• 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

  Immediately after the end of the catheterization

Secondary Outcomes (1)

• pain score

  Immediately after the end of the catheterization

Study Arms (3)

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

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

Device: Virtual reality technology; Other: different timing of lidocaine injection

Interventions

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.

Group B; Group C

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.

Group C

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qi Yu: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

Study Officials

• Lijuan Feng

  Tongji Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief nurse

Model Details: 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

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 20, 2024
• Study Start: May 21, 2020
• Primary Completion: April 17, 2021
• Study Completion: May 28, 2021
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)