Clinical trial NCT05857917: Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion
Official title: Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Function Disorder
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Procedure-related pain
timeFrame: recorded within 30 minutes after surgery
measure: Anxiety assessment 30 minutes before surgery
timeFrame: 30 minutes before surgery
measure: Patient satisfaction
timeFrame: within 30 minutes after surgery
Secondary outcomes:
measure: Postoperative analgesics usage
timeFrame: after the operation until discharge from hospital
measure: Distribution of systolic blood pressure of patients in the intraoperative period
timeFrame: 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.
measure: Distribution of diastolic blood pressure of patients in the intraoperative period
timeFrame: 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.
measure: Distribution of pulse rates of patients in the intraoperative period
timeFrame: 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.
measure: Distribution of respiratory rates of patients in the intraoperative period
timeFrame: 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.
measure: Patient reported pain post procedure
timeFrame: recorded at 4 hours post operation, and 24 hour intervals to four days post operation.
Other outcomes:
measure: VR Questionnaire
timeFrame: within 30 minutes after surgery
measure: Catheter insertion related complications
timeFrame: through study completion, an average of 10 days
Locations:
city: Guangzhou
country: China
facility: First affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: