Renal Function DisorderNCT05857917
Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion
A study testing Virtual Reality in people with Renal Function Disorder, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Function Disorder
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, male or female.
- Patients receiving PD catheter insertion for the first time.
- Signed informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Chen, M.D, Ph.D., 020-87769673, chenwei99@mail.sysu.edu.cn
About this study
Official title: Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion: A Pilot Study
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.
Read the 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
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual reality in PD catheter insertion surgery in the pre- and intraoperative setting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
| Standard care group | No intervention | The participants randomized to this group will receive the usual standard preoperative and intraoperative management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes before surgery
Patient satisfaction
5-point Likert verbal rating scale: 5, extremely satisfied; 4, satisfied; 3, undecided; 2, dissatisfied; 1, extremely dissatisfied.
Measured: within 30 minutes after surgery
Secondary outcomes (6)
Postoperative analgesics usage
The use of paracetamol, NSAIDs, opioids, and other analgesics administered to the patients after surgery to relieve the pain caused by the operation.
Measured: after the operation until discharge from hospital
Distribution of systolic blood pressure of patients in the intraoperative period
Difference between the highest value during the operation and the baseline value.
Measured: 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
Difference between the highest value during the operation and the baseline value.
Measured: 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
Difference between the highest value during the operation and the baseline value.
Measured: 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
Difference between the highest value during the operation and the baseline value.
Measured: 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.
Patient reported pain post procedure
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.
Measured: recorded at 4 hours post operation, and 24 hour intervals to four days post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start17 Apr 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857917
- Sponsor's protocol ID
- ITT-2023-130
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion: A Pilot Study
- ClinicalTrials.gov ID
- NCT05857917
- Acronym / sponsor ID
- ITT-2023-130
- Conditions
- Renal Function Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual RealityParticipants 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. |
| Standard care group | No intervention | –The participants randomized to this group will receive the usual standard preoperative and intraoperative management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years, male or female.
- Patients receiving PD catheter insertion for the first time.
- Signed informed consent form.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual reality in PD catheter insertion surgery in the pre- and intraoperative setting. | Device | VR group |
Primary outcome
Procedure-related pain
Time frame: recorded within 30 minutes after surgery
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.
Anxiety assessment 30 minutes before surgery
Time frame: 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.
Patient satisfaction
Time frame: within 30 minutes after surgery
5-point Likert verbal rating scale: 5, extremely satisfied; 4, satisfied; 3, undecided; 2, dissatisfied; 1, extremely dissatisfied.
6 secondary outcomes
Postoperative analgesics usage
Time frame: after the operation until discharge from hospital
Distribution of systolic blood pressure of patients in the intraoperative period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Patient reported pain post procedure
Time frame: recorded at 4 hours post operation, and 24 hour intervals to four days post operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Renal Function Disorder, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen, M.D., Ph.D. (020-87769673, chenwei99@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related pain (time frame: recorded within 30 minutes after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.