PainNCT06279481
Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy
A study testing Nonpharmacological method in people with Pain and Colonoscopy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy. Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain, Colonoscopy
- What is being tested?
- Nonpharmacological method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to Dec 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 50 years of age
- Able to cooperate and complete the questionnaires independently
- Stable vital signs with no serious cardiovascular or cerebrovascular diseases
- Voluntary participation
Who cannot join
- Severely impaired in vision or hearing to accommodate VR devices
- Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100010
About this study
Official title: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study
Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.
Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.
Read the detailed description
Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.
- Conditions
- Pain, Colonoscopy
- Being tested
- Nonpharmacological method
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonpharmacological methodOther
Virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation. Receives: Other: Nonpharmacological method |
| Control | No intervention | Patients undergo traditional colonoscopy procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Visual Analogue Scale Mean Scores by Groups
Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome.
Measured: Evaluated immediately after colonoscopy.
Secondary outcomes (8)
Comparison of State Trait Anxiety Inventory Mean Scores by Groups
State Trait Anxiety Inventory evaluates anxiety with a scale containing 20 items, scoring between 20 points (no anxiety) to 80 points (high anxiety).
Measured: Evaluated immediately both prior and after colonoscopy.
Comparison of Vital Signs between Groups: Pulse Rate
All vital signs of patients will be measured by a same multifunctional ECG monitor.
Measured: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Blood Pressure
All vital signs of patients will be measured by a same multifunctional ECG monitor.
Measured: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Respiration Rate
All vital signs of patients will be measured by a same multifunctional ECG monitor.
Measured: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Oxygen Saturation
All vital signs of patients will be measured by a same multifunctional ECG monitor.
Measured: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Patient Satisfaction of Colonoscopy between Groups
Patient satisfaction will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher satisfaction. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration.
Measured: Evaluated immediately after colonoscopy.
Comparison of Patient Willingness of Future Colonoscopy between Groups
Patient willingness to undergo future colonoscopies will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher willingness. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration.
Measured: Evaluated immediately after colonoscopy.
Comparison of Adverse Effects in both groups
Any adverse effect (e.g. nausea, vomiting, headache, or dizziness) would be immediately recorded.
Measured: During and immediately after colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Model description
- a single-centered, prospective, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingyun Yang, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279481
- Sponsor's protocol ID
- PUMCH-K2458
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06279481
- Acronym / sponsor ID
- PUMCH-K2458
- Conditions
- Pain, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.
Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.
Detailed description
Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a single-centered, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Nonpharmacological methodThe virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation. |
| Control | No intervention | –Patients undergo traditional colonoscopy procedures. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 50 years of age
- Able to cooperate and complete the questionnaires independently
- Stable vital signs with no serious cardiovascular or cerebrovascular diseases
- Voluntary participation
Key exclusion criteria (2 listed)
- Severely impaired in vision or hearing to accommodate VR devices
- Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy
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 |
|---|---|---|
| Nonpharmacological methodVirtual reality | Other | Virtual Reality |
Primary outcome
Comparison of Visual Analogue Scale Mean Scores by Groups
Time frame: Evaluated immediately after colonoscopy.
Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome.
8 secondary outcomes
Comparison of State Trait Anxiety Inventory Mean Scores by Groups
Time frame: Evaluated immediately both prior and after colonoscopy.
Comparison of Vital Signs between Groups: Pulse Rate
Time frame: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Blood Pressure
Time frame: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Respiration Rate
Time frame: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Vital Signs between Groups: Oxygen Saturation
Time frame: Evaluated both before and every 3 minutes during colonoscopy.
Comparison of Patient Satisfaction of Colonoscopy between Groups
Time frame: Evaluated immediately after colonoscopy.
Comparison of Patient Willingness of Future Colonoscopy between Groups
Time frame: Evaluated immediately after colonoscopy.
Comparison of Adverse Effects in both groups
Time frame: During and immediately after colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Yingyun Yang, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonpharmacological method in people with Pain and Colonoscopy, run by Peking Union Medical College Hospital 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 4 inclusion and 2 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 25 Nov 2024. 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 Yingyun Yang, MD (18510031805 ext. +86, yingyunyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Visual Analogue Scale Mean Scores by Groups (time frame: Evaluated immediately after colonoscopy.). 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 25 Nov 2024.