|- candidate number||25392|
|- NTR Number||NTR6175|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-okt-2016|
|- Secondary IDs||2016-2750 Commissie Mensgebonden Onderzoek Nijmegen-Arnhem|
|- Public Title||The use of Virtual Reality for Patient Diversion during colonoscopy - feasability study|
|- Scientific Title||Virtual Reality for Patient Diversion during colonoscopy - feasability study|
|- hypothesis||Patients who undergo colonoscopy are subject to discomfort related to the procedure; is it feasable to enhance patient comfort with Virtual Reality glasses worn during colonoscopy?|
|- Healt Condition(s) or Problem(s) studied||Colonoscopy, Anxiety, Virtual Reality|
|- Inclusion criteria||-Aged above 18|
-Indication of colonscopy
|- Exclusion criteria||-Visual and/or auditory impaired |
-Limited Dutch language skills
-Diagnosed with balance disorders or epilepsy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-okt-2016|
|- planned closingdate||28-nov-2016|
|- Target number of participants||24|
|- Interventions||Patients wear a set of virtual reality glasses showing 360 degrees nature video's during colonoscopy|
|- Primary outcome||Feasibility of the use of virtual reality glasses during current default colonoscopic procedures including sedation.
(patient wear virtual reality glasses whole procedure, communication with patient is not restricted, effect on combining sedation and VR)
|- Secondary outcome||- Are patients satisfied according to the type of colonoscopy? (with or without VR glasses)|
- Are patients wearing VR glasses less anxious after colonoscopy compared to patients who did not wear VR glasses?
- Is the pain score of patients wearing VR glasses lower compared to the pain score of patients who did not wear VR glasses?
- Is there less need to apply additional sedation when VR is used?
|- Timepoints||Questionnaires are filled out at:|
Inclusion (at home)
Pre colonoscopy (in the hospital)
During colonoscopy (by the researcher)
Post colonoscopy (in the hospital)
|- Trial web site||n/a|
|- CONTACT FOR PUBLIC QUERIES||MD Govert Veldhuijzen|
|- CONTACT for SCIENTIFIC QUERIES||MD Govert Veldhuijzen|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Centre Nijmegen|
|- Brief summary||Colonoscopy is a highly invasive examination performed for: 1) screening, diagnosis, and sometimes treatment of colorectal cancer; 2) evaluating inflammatory bowel disease; and 3) detecting other structural lesions in the colon. In 2014, 242,900 colonoscopic procedures were performed in the Netherlands , and these numbers increase by the year. Due to the invasive nature of the examination, patients may experience pain and discomfort during colonoscopy . Unpleasant experience with colonoscopy may cause anxiety of experiencing the same amount of unpleasantness during prospective colonoscopy, causing patients to refuse colonoscopy . Sedative medication is used to relieve pain and discomfort during the procedure. Although sedative medication has positive effects on pain and discomfort, it may cause adverse effects .|
Several studies were performed to reduce pain and discomfort during endoscopy [5-11]. These studies were focused on visual [6, 8, 11], auditory [5, 7, 11], acupunctural , and slow-wave photic  distraction, and show promising results. Lembo et al. suggested that combined visual and auditory distraction has a higher effect on reducing abdominal discomfort during flexible sigmoidoscopies compared to auditory distraction alone .
A technique which uses a combination of visual and auditory distraction and which is suggested to have an analgesic and relaxing effect is virtual reality (VR) [12, 13]. VR allows the user to participate in a simulated environment. The field of burn wound therapy has been the primary interest in implementing VR, since wound debridement in patients with burn wounds is a painful intervention. Several studies have shown the potential of VR in pediatric and adult burn wound patients [14-16]. In addition, a study of Furman et al. VR distraction was used to relieve pain and unpleasantness in patients receiving dental treatment . This study showed that a higher patient satisfaction was reached by procedures using VR distraction compared to procedures using auditory distraction or without any distraction at all.
Research has been performed towards the functional mechanism of action of VR in the brain. Hoffman et al. investigated the effects of VR distraction on pain related brain activity using fMRI . The results show that VR distraction has positive effects on pain related brain activity in five regions associated with pain sensation, when VR is used as an additional analgesia. The results of the study of Hoffman et al. are promising for implementing VR distraction into other medical procedures, e.g. colonoscopy, to relieve procedural pain and discomfort.
Although studies have been performed to reduce pain and discomfort during endoscopic procedures. To the best of our knowledge, no studies have been performed to reduce pain and discomfort during colonoscopy using VR. Therefore, in our study we wanted to investigate the feasibility of using VR distraction during colonoscopy to reduce pain and anxiety.
|- Main changes (audit trail)|
|- RECORD||11-okt-2016 - 19-feb-2017|