Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion

NCT05857917 | Unknown DMC

• 1 other identifier: ITT-2023-130
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to investigate the effect of VR application on reducing preoperative anxiety and the intraoperative and postoperative pain of patients who undergo peritoneal dialysis catheter insertion. The main questions it aims to answer are: 1) Whether preoperative VR application can reduce preoperative anxiety in patients undergoing peritoneal dialysis catheter insertion; 2) Whether intraoperative VR application can reduce intraoperative and postoperative pain in patients undergoing peritoneal dialysis catheter insertion; 3) Whether VR application can improve patients satisfaction of the operation. Participants will be randomly assigned to the VR group and control group, and participants in the VR group will be introduced to VR use and watch a VR video about the operating room environment 1 day before the surgery. During the procedure, participants in the VR group will watch a soothing video through the VR device. In contrast, participants in the control group will receive the usual preoperative and surgical procedures. Preoperative anxiety, intraoperative and postoperative pain, and patient satisfaction will be compared between the two arms.

Conditions

Renal Function Disorder

Outcome Measures

Primary Outcomes (3)

• Procedure-related pain

  Measured by Visual Analogue Scale (VAS) pain measurement scale divided from 0 to 10 where 0 is no pain and 10 worst pain that can be imagined.

  recorded within 30 minutes after surgery

• Anxiety assessment 30 minutes before surgery

  State-Trait Anxiety Scale (STAI) was applied in the preoperative period, and only the 20-item state scale construct was used.

  30 minutes before surgery

• Patient satisfaction

  5-point Likert verbal rating scale: 5, extremely satisfied; 4, satisfied; 3, undecided; 2, dissatisfied; 1, extremely dissatisfied.

  within 30 minutes after surgery

Secondary Outcomes (6)

• Postoperative analgesics usage

  after the operation until discharge from hospital

• Distribution of systolic blood pressure of patients in the intraoperative period

  Baseline values are measured 30 minutes before the procedure, then the values at 5 minutes after the start of the procedure and every 15 minutes thereafter are recorded.

• Distribution of diastolic blood pressure of patients in the intraoperative period

  Baseline values are measured 30 minutes before the procedure, then the values at 5 minutes after the start of the procedure and every 15 minutes thereafter are recorded.

• Distribution of pulse rates of patients in the intraoperative period

  Baseline values are measured 30 minutes before the procedure, then the values at 5 minutes after the start of the procedure and every 15 minutes thereafter are recorded.

• Distribution of respiratory rates of patients in the intraoperative period

  Baseline values are measured 30 minutes before the procedure, then the values at 5 minutes after the start of the procedure and every 15 minutes thereafter are recorded.

Other Outcomes (2)

• VR Questionnaire

  within 30 minutes after surgery

• Catheter insertion related complications

  through study completion, an average of 10 days

Study Arms (2)

VR group

EXPERIMENTAL

Participants randomized into this group will be introduced to VR use and watch a VR video that introduces the operating room environment 1 day before surgery and play a soothing video through VR during the surgery.

Device: Virtual Reality

Standard care group

NO INTERVENTION

The participants randomized to this group will receive the usual standard preoperative and intraoperative management.

Interventions

Virtual Reality DEVICE

Virtual reality in PD catheter insertion surgery in the pre- and intraoperative setting.

VR group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years, male or female.
• Patients receiving PD catheter insertion for the first time.
• Signed informed consent form.

You may not qualify if:

• Hearing and vision impairments, or affective disorder.
• Communication is not possible due to impaired cognitive ability.
• History of epilepsy or seizure.
• History of long-term use of pain medication (opioids).
• History of severe cardiac failure (NYHA IV), acute myocardial infarction, or severe acute infection in recent three months.
• Patients who refuse to use VR.
• Other conditions deemed unsuitable by physicians.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

First affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Central Study Contacts

Wei Chen, M.D., Ph.D.

CONTACT

020-87769673; chenwei99@mail.sysu.edu.cn

Sixiu Chen, M.D.

CONTACT

020-87769673; chensx53@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 15, 2023
• Study Start: April 17, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CN (1)