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

NCT ID: NCT05857917

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-10-30

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.

Detailed Description

Peritoneal dialysis (PD) is an important alternative treatment modality for end-stage renal disease. Patients are required to undergo catheter insertion prior to PD. However, Patients undergoing catheterization for the first time often experience preoperative anxiety, and the procedure is usually performed under local anesthesia. Moreover, patients under local anesthesia are prone to significant intraoperative pain and poor surgical cooperation, which compromises the procedure and leads to low patient satisfaction. In recent years, virtual reality (VR) has been found to reduce preoperative anxiety and acute or chronic pain in medical fields such as pediatrics and dentistry. It is a non-invasive, accessible, safe, and effective modality. There is a lack of research on the use of virtual reality technology in peritoneal dialysis catheterization, so this study proposes to study the effect of VR application on reducing preoperative anxiety and intraoperative and postoperative pain in patients using VR before and during catheter insertion.

The study is a prospective, randomized, controlled, single-center study. Patients who meet the enrollment criteria will be randomly assigned to either the VR group or the control group. The VR group will be introduced to the use of VR and watch a VR video introducing the operating room environment 1 day prior to surgery, and play soothing audio/video via VR during surgery; the control group will undergo routine preoperative and surgical procedures. Preoperative anxiety, intraoperative and postoperative pain, and patient satisfaction will be assessed between the two groups.

Conditions

Renal Function Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR group

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

Standard care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wei Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

chenwei99@mail.sysu.edu.cn

020-87769673

Sixiu Chen, M.D.

Role: CONTACT

chensx53@mail.sysu.edu.cn

020-87769673

Facility Contacts

Wei Chen, M.D, Ph.D.

Role: primary

chenwei99@mail.sysu.edu.cn

020-87769673

Other Identifiers

ITT-2023-130

Identifier Type: -

Identifier Source: org_study_id