Clinical trial · Interventional
Distracting Through Procedural Pain and Distress
Comparison of Guided Imagery and Virtual Reality (VR) Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures
NCT04892160CI-TRIAL-00051890completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Children with acute and chronic illness undergo frequent, painful, and distressing procedures. This randomized control trial was used to evaluate the effectiveness of guided imagery (GI) vs virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing un-sedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Transplant Infection | — | UNRESOLVED | — |
| Chronic Illness | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guided Imagery | Other | — | UNRESOLVED |
| Virtual Reality | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Guided Imagery First/Virtual Reality Second
- description
- Patients will be played a guided imagery experience first during one of the following procedures: port access, dressing changes, and IV sticks. The second scheduled procedure will be the same procedure as the first and occur within 5 to 40 days. At the time of their second procedure, they will receive the virtual reality intervention.
- interventionNames
- Other: Guided Imagery
- Other: Virtual Reality
- type
- EXPERIMENTAL
- label
- Virtual Reality First/Guided Imagery Second
- description
- Patients will have the VR interactive experience played first during one of the following procedures: port access, dressing changes, and IV sticks. The second scheduled procedure will be the same procedure as the first and occur within 5 to 40 days. At the time of their second procedure, they will receive the guided imagery intervention.
- interventionNames
- Other: Guided Imagery
- Other: Virtual Reality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals being seen by the hematology, oncology, and blood and marrow transplant services. * English-speaking patients between the ages of 8-25 years that are at least one month post-diagnosis. * Has one of the three qualifying procedures: port access, dressing changes, and IV sticks. Exclusion Criteria: * Patients having identified physical impairments (e.g., blindness, active infection of the skin, history of seizure disorder) that would prevent them from using VR equipment. * Patients with significant developmental delays that would prevent them from completing required study forms.
References
Publications (27)
- BACKGROUNDAsl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12. PMID 23277857
- BACKGROUNDBlount, R.L., Zempsky, W.T., Jaaniste, T., Evans, S., Cohen, L.L., Devine, K.A., & Zeltzer, L.K. (2009). Management of pediatric pain and distress due to medical procedures. In M.C. Roberts & R.G. Steele (Eds.), Handbook of Pediatric Psychology (pp. 171-188), New York: The Guilford Press.
- BACKGROUNDDahlquist LM, McKenna KD, Jones KK, Dillinger L, Weiss KE, Ackerman CS. Active and passive distraction using a head-mounted display helmet: effects on cold pressor pain in children. Health Psychol. 2007 Nov;26(6):794-801. doi: 10.1037/0278-6133.26.6.794. PMID 18020853
- BACKGROUNDDas DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1. PMID 15745448
- BACKGROUNDDeraney J, Davis M, Evers HB, German K, Hamill JC, Karas-Irwin BS, Mazzer MC, Shaw RE. Drumming Effect on Anxiety. Arch Psychiatr Nurs. 2017 Oct;31(5):528-529. doi: 10.1016/j.apnu.2017.05.001. Epub 2017 May 13. No abstract available. PMID 28927519
- BACKGROUNDGershon J, Zimand E, Lemos R, Rothbaum BO, Hodges L. Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Cyberpsychol Behav. 2003 Dec;6(6):657-61. doi: 10.1089/109493103322725450. PMID 14756933
- BACKGROUNDGershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05.