Distracting Through Procedural Pain and Distress

NCT04892160 | Completed

• 1 other identifier: 1110230
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

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

Chronic Illness; Hematologic Malignancy; Bone Marrow Transplant Infection; Oncology; Sickle Cell Disease

Keywords

Procedural Pain; Anxiety; Pediatric; Virtual Reality; Guided Imagery

Outcome Measures

Primary Outcomes (6)

• GI vs. VR in patient pain via the Pain Catastrophizing Scale (PCS)

  GI will be compared to VR when it comes to the Pain Catastrophizing Scale for Children (PCS) to identify subgroups that may respond better to one intervention over another. Patient perceptions of pain will be assessed prior to the first procedure using either the child (for patients 8-16 years) or adult (for patients 17+ years) version of the Pain Catastrophizing Scale (PCS). The PCS is a 13-question survey which assesses thoughts and feelings related to pain on a 5 point scale ranging from "not at all" to "extremely."

  The PCS will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).

• GI vs. VR in patient pain via the Visual Analogue Scale (VAS)

  GI will be compared to VR when it comes to the Visual Analogue Scale (VAS). This measure is used to assess pain and distress across 6 domains: (1) highest level of pain, (2) average amount of pain, (3) anxiety about pain, (4) unpleasantness of pain, (5) bothersomeness of pain, and (6) time spent thinking about pain. Scores range from 0-100 on each item.

  The VAS will be completed by the patient within 10 minutes after completion of each intervention (i.e., GI and VR intervention).

• GI vs. VR in patient pain via Children's Emotional Manifestation of Pain Scale (CEMS)

  GI will be compared to VR when it comes to the Children's Emotional Manifestation of Pain (CEMS). This observational measure offers an objective way to measure distress during difficult medical experiences. It includes the following domains: anxiety score, facial expression, vocalization, activity, interaction, and level of cooperation.

  The CEMS will be completed by study staff during each intervention. Study staff will assess the patients through the duration of the procedure and intervention that same day.

• GI vs. VR in patient anxiety via State Trait Anxiety Inventory - Trait (STAI-T)

  GI will be compared to VR when it comes to the State-Trait Anxiety Inventory-Trait (STAI-T) to identify subgroups that may respond better to one intervention over another. This measure is used to assess a patient's trait (underlying or baseline) anxiety. There is a child portion for patients 8-16 years or an adult portion for patients 17+ years.

  The STAI-T will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).

• GI vs. VR in patient anxiety via STAI-State Pre-Intervention

  GI will be compared to VR when it comes to the STAI-State. This assessment is used to assess a patient's state (in the moment) anxiety. There is only one version for all ages.

  STAI-State will be completed 10 minutes prior to the first and second procedure (GI and VR).

• GI vs. VR in patient anxiety via STAI-State Post-Intervention

  GI will be compared to VR when it comes to the STAI-State. This assessment is used to assess a patient's state (in the moment) anxiety. There is only one version for all ages.

  STAI-State will be completed 10 minutes after the first and second intervention (GI and VR).

Secondary Outcomes (5)

• GI vs. VR in parent distress via PCS-P

  The PCS-P will be completed by the caregiver 10 minutes before the first procedure or intervention.

• GI vs. VR in parent distress via Emotional Adjective Survey

  The Emotion Adjective Survey will be completed by the caregiver 10 minutes after each intervention.

• GI vs VR in hospital resource utilization via Staff Time

  The Staff Time log is completed by a member of the study team. It begins once the nursing staff member opens the sterile kit used for the current procedure and ends when the procedure is completed after each intervention.

• GI vs VR in hospital resource utilization via Procedure Time

  The Procedure Time log is completed by a member of the study team. The time begins once the nursing staff member opens the sterile kit used for the current procedure and ends when the procedure is completed/

• Nurse Feasibility and Acceptability

  The Nurse Feasibility and Acceptability survey will be completed within one day following completion of each intervention.

Study Arms (2)

Guided Imagery First/Virtual Reality Second

OTHER

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.

Other: Guided Imagery; Other: Virtual Reality

Virtual Reality First/Guided Imagery Second

EXPERIMENTAL

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.

Other: Guided Imagery; Other: Virtual Reality

Interventions

Guided Imagery OTHER

Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will play an audio recording of an underwater guided imagery during one of these procedures: port access, dressing changes, and IV sticks. Guided imagery is an intervention that relies on a patient's imagination to create a sensory experience that utilizes mental images, sounds, smells, tastes, and touch. The guided imagery script used in this study describes an underwater scene and is meant to closely mimic the VR condition with the exception that it will be non-immersive. It will last approximately 15 minutes but can be played again if the procedure lasts longer than 15 minutes. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.

Guided Imagery First/Virtual Reality Second; Virtual Reality First/Guided Imagery Second

Virtual Reality OTHER

Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will assist the patient in beginning the VR intervention during one of these procedures: port access, dressing changes, and IV sticks. The VR intervention consists of interactive audio and visual underwater experience. The VR software offers both passive and active gameplay over the course of 15 minutes, which can be repeated. In the passive experience, the software moves patients through an ocean filled with sea creatures and allows them to look around and observe the underwater scene. In the active experience, patients launch balls at the fish. Patients will be encouraged but not required to actively participate; staff will record whether the patient participates in the active portion of the VR program. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.

Guided Imagery First/Virtual Reality Second; Virtual Reality First/Guided Imagery Second

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Northwestern Mutual Foundation: collaborator

Study Sites (2)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (27)

• Asl 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 BACKGROUND

• Blount, 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.

  BACKGROUND

• Dahlquist 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 BACKGROUND

• Das 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 BACKGROUND

• Deraney 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 BACKGROUND

• Gershon 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 BACKGROUND

• Gershon 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.

  PMID: 15381891 BACKGROUND

• Gold, J. I., Kant, A. J., & Kim, S. H. (2005, December). Virtual anesthesia: the use of virtual reality for pain distraction during acute medical interventions. In Seminars in Anesthesia, Perioperative Medicine and Pain (Vol. 24, No. 4, pp. 203-210). WB Saunders.

  BACKGROUND

• Hoffman HG, Doctor JN, Patterson DR, Carrougher GJ, Furness TA 3rd. Virtual reality as an adjunctive pain control during burn wound care in adolescent patients. Pain. 2000 Mar;85(1-2):305-9. doi: 10.1016/s0304-3959(99)00275-4.

  PMID: 10692634 BACKGROUND

• Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.

  PMID: 24823326 BACKGROUND

• Kazak AE, Penati B, Brophy P, Himelstein B. Pharmacologic and psychologic interventions for procedural pain. Pediatrics. 1998 Jul;102(1 Pt 1):59-66. doi: 10.1542/peds.102.1.59.

  PMID: 9651414 BACKGROUND

• Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

  PMID: 21925588 BACKGROUND

• Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.

  PMID: 20691523 BACKGROUND

• Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.

  PMID: 27349654 BACKGROUND

• Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

  PMID: 19230769 BACKGROUND

• Powers SW. Empirically supported treatments in pediatric psychology: procedure-related pain. J Pediatr Psychol. 1999 Apr;24(2):131-45. doi: 10.1093/jpepsy/24.2.131.

  PMID: 10361392 BACKGROUND

• Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol Nurs Forum. 2002 Jan-Feb;29(1):E8-E15. doi: 10.1188/02.ONF.E8-E15.

  PMID: 11845217 BACKGROUND

• Schneider SM, Workman ML. Effects of virtual reality on symptom distress in children receiving chemotherapy. Cyberpsychol Behav. 1999;2(2):125-34. doi: 10.1089/cpb.1999.2.125.

  PMID: 19178248 BACKGROUND

• Schneider SM, Prince-Paul M, Allen MJ, Silverman P, Talaba D. Virtual reality as a distraction intervention for women receiving chemotherapy. Oncol Nurs Forum. 2004 Jan-Feb;31(1):81-8. doi: 10.1188/04.ONF.81-88.

  PMID: 14722591 BACKGROUND

• Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004.

  PMID: 18036981 BACKGROUND

• Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

  PMID: 28356241 BACKGROUND

• Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.

  PMID: 18387963 BACKGROUND

• Windich-Biermeier A, Sjoberg I, Dale JC, Eshelman D, Guzzetta CE. Effects of distraction on pain, fear, and distress during venous port access and venipuncture in children and adolescents with cancer. J Pediatr Oncol Nurs. 2007 Jan-Feb;24(1):8-19. doi: 10.1177/1043454206296018.

  PMID: 17185397 BACKGROUND

• Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. doi: 10.1207/s15324796abm3003_11.

  PMID: 16336078 BACKGROUND

• Wolitzky, K., Fivush, R., Zimand, E., Hodges, L., & Rothbaum, B. O. (2005). Effectiveness of virtual reality distraction during a painful medical procedure in pediatric oncology patients. Psychology and health, 20(6), 817-824.

  BACKGROUND

• Zernikow B, Meyerhoff U, Michel E, Wiesel T, Hasan C, Janssen G, Kuhn N, Kontny U, Fengler R, Gortitz I, Andler W. Pain in pediatric oncology--children's and parents' perspectives. Eur J Pain. 2005 Aug;9(4):395-406. doi: 10.1016/j.ejpain.2004.09.008.

  PMID: 15979020 BACKGROUND

• Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;24(4):e30260. doi: 10.2196/30260.

  PMID: 35436209 DERIVED

MeSH Terms

Conditions

Chronic Disease; Hematologic Neoplasms; Neoplasms; Anemia, Sickle Cell; Pain, Procedural; Anxiety Disorders

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Hoag, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 19, 2021
• Study Start: February 15, 2018
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We will share study documents once the manuscript has been published.
• Access Criteria: A researcher who would like to use our data has to contact and get permission from the PI, Jennifer Hoag, PhD.

Locations

US (2)