Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03933124
Other study ID # NL69077.091.19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2019
Est. completion date February 11, 2021

Study information

Verified date October 2020
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effect of Virtual Reality (VR) on pain and recovery in 100 post-operative patients. 60 patients will be included in the intervention group; they will use VR minimal 3 times a day on day 2-4 after surgery, on the surgical ward, as an add-on intervention next to standard care. 40 patients in the control group will only receive standard postoperative care.


Description:

Adequate management of post-surgical pain (PSP) may contribute to improved clinical and socioeconomic outcomes. Facilitating an adequate level of PSP relief is a challenging problem: the analgesics that are most frequently used, for example, opioids and non-steroidal anti-inflammatory drugs (NSAIDs), often come with side effects and do not always provide sufficient pain relief. Therefore, pain management is increasingly focusing on (additional) non-pharmacological analgesics, including Virtual Reality (VR). VR immerses the user in a virtual world through a head mounted device (HMD). VR is, among other things, taught to be effective through distraction: it diverts attention away from the nociceptive input, resulting in less available attention for pain perception. In both clinical and experimental studies, VR has shown to be effective in reducing pain, anxiety and stress. Although this distraction method is increasingly studied in the past years, VR pain relief has mostly been investigated as an intervention during painful procedures in specific research populations. For example, VR has been studied during wound dressing changes in burn wound patients in children and adolescents, during venipuncture in children or during dental treatments. Furthermore, most VR studies used VR as a single intervention, measuring pre-post differences in pain scores or used a cross over design with one VR session and one control session. It is interesting to know whether VR is effective in reducing postoperative pain during more than one VR session. More research is needed in larger trials evaluating a broad sample of the general population including elderly, as the common hospitalized patient is of an older age nowadays. Finally, it is important to evaluate the feasibility and acceptability of VR in postoperative patients and to know whether there are predictive factors to select patients who can mostly benefit from VR interventions.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 11, 2021
Est. primary completion date February 11, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Patient underwent surgery - Patient reports a postoperative pain score =4 on the first postoperative day at the surgical ward and pain score should also be marked with 'pain is not acceptable'. - At the day of recruitment, the estimated length of stay is at least 4 days after inclusion. - Patient is willing and able to comply with the trial protocol. - Patient is at least 16 years old on the day the informed consent form will be signed. Exclusion Criteria: - Patient suffers from delirium or acute confusional state. - Patient has (a history of) dementia, seizure or epilepsy. - Patient with severe hearing/visual impairment not corrected. - Patient is placed in isolation. - The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema). - Unplanned (re)admission to the intensive care unit (ICU). - Inclusion in another trial to evaluate new ways of treating pain

Study Design


Intervention

Device:
Virtual Reality
The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.

Locations

Country Name City State
Netherlands Radboud university medical center Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Daily pain score (VAS, visual analogue scale) Pain on average in the last 24h. VAS (visual analogue scale): 0-100 mm, 0 is defined as "no pain at all", 100 is "the worst pain the patient can imagine". day 1-4, the first four postoperative days on the surgical ward
Secondary Time to 30% pain reduction compared to pain scores on postoperative day 1. Time to 30% pain reduction compared to pain scores on postoperative day 1. day 1-4, the first four postoperative days on the surgical ward.
Secondary Mean Daily worst pain score (VAS) Worst pain in the last 24h. day 1-4, the first four postoperative days on the surgical ward.
Secondary Effect of pain on mobility (NRS, Numeric Rating Scale) NRS score (Numeric Rating Scale): 0-10. 0 is defined as "no pain at all", 10 is "the worst pain the patient can imagine". day 1-4, the first four postoperative days on the surgical ward.
Secondary Difference in pain scores pre- and post- VR intervention (VAS) Pain pre- and postintervention in the VR intervention group. Day 2-4 on the surgical ward.
Secondary Quality of recovery -15 questionnaire. Quality of recovery -15 questionnaire. day 1-4, the first four postoperative days on the surgical ward.
Secondary Mean Daily Anxiety score (VAS). Anxiety on average in the last 24h. day 1-4, the first four postoperative days on the surgical ward.
Secondary Mean Daily Stress score (VAS) Stress on average in the last 24h. day 1-4, the first four postoperative days on the surgical ward.
Secondary State-Trait Anxiety Inventory (STAI)-6 questionnaire. State-Trait Anxiety Inventory (STAI)-6 questionnaire. day 1-4, the first four postoperative days on the surgical ward.
Secondary Difference in anxiety scores pre- and post- VR intervention. (VAS) Anxiety pre- and postintervention in the VR intervention group. Day 2-4 on the surgical ward.
Secondary Difference in stress scores pre- and post- VR intervention. (VAS) Stress pre- and postintervention in the VR intervention group. Day 2-4 on the surgical ward.
Secondary Difference in depression scores pre- and post- VR intervention. (VAS) Depression pre- and postintervention in the VR intervention group. Day 2-4 on the surgical ward.
Secondary Analgesic use Analgesic use (paracetamol, NSAIDs, opioids, use of add-on/escape medication, daily defined dose of opioid, days to removal of epidural analgesia or PCA (patient-controlled intravenous analgesia, morphine IV), days to converting from opioids to NSAIDs or paracetamol without opioids). day 1-4, the first four postoperative days on the surgical ward.
Secondary Feasibility of VR Questionnaire, interview Day 1-4 postoperative
Secondary Patients acceptability Questionnaire, interview Day 1-4 postoperative
Secondary Tolerability of Virtual Reality Questionnaire, interview Day 1-4 postoperative
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care