Distracting Through Procedural Pain and Distress

Sickle Cell Disease Clinical Trial

Official title:

Comparison of Guided Imagery and Virtual Reality (VR) Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892160
• Other study ID #: 1110230
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: April 29, 2019

Study information

• Verified date: May 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Treatment for pediatric cancer and blood disorders can range from several months to several years. During the course of treatment, children often undergo several painful and/or frightening procedures. Common unsedated procedures include needle access of an implanted central venous port (i.e., "port access") prior to receiving chemotherapy; intravenous needle sticks to provide chronic transfusion therapy or treatment for iron overload in patients with sickle cell disease; and weekly changing of the bandage (dressing) around a peripherally inserted central catheter (PICC). These procedures are often distressing to a pediatric patient. As a result, there is an emphasis on the use of non-pharmacologic interventions to manage symptoms of patient pain and anxiety for procedures that do not warrant pharmacologic intervention. There is also ample evidence to suggest that parental coping is associated with child distress, which highlights the need for interventions that have the potential to decrease parental, as well as patient, distress. Interventions that are cost-effective and sustainable are most appealing in the current healthcare environment.

Non-immersive distraction, such as guided imagery, is widely regarded as useful in decreasing pain and anxiety during procedures. Guided imagery is a cognitive strategy that typically involves a staff member describing in detail a situation that is incompatible with the experience of pain and is meant to invoke feelings of calm. It is a commonly used intervention to address procedural distress and, aside from staff time, is free of cost. However, that the more distracting the stimuli, the greater the expenditure of cognitive energy, and the greater reduction in one's capacity to process pain and feel distressed. This leads one to question whether VR, an immersive, interactive technology that can realistically project three-dimensional images, may be more effective than a non-immersive distraction in managing procedure-related pain and distress. VR has been used to assist with procedural distress in several contexts over the past 15 years, including pediatric pain, burn care, dental procedures, and port access. Reviews of VR usage have been generally positive, with most studies suggesting that VR is a feasible and efficacious method of distraction that can reduce patient-reported and objective physiological measures of pain and distress. Effect sizes in the medium to the large range have been found when comparing VR to standard of care and non-immersive distraction (e.g., videogames), have found that subjects using VR distraction for pain showed more improvement than approximately 83% of control subjects. Other sources have highlighted positive patient satisfaction and a low incidence of negative side effects (e.g., motion sickness) when using VR. The cost of VR equipment has decreased over the years, although VR headsets still average $300-500 with additional cost for game controllers and smartphones/game systems. For use within a hospital, the further cost would need to be incurred to reduce the risk of infection for equipment that is shared.

Using a comparative effectiveness model, this project will compare a low-cost, but widely accepted non-immersive distraction intervention (guided imagery) to a higher cost, but very promising immersive intervention (VR) in managing patient pain and anxiety, as well as parent distress. To our knowledge, this is the first time these two interventions will be directly compared. It is also the first time that parental distress will be measured as an outcome of a VR intervention. Hospital resource utilization (staff time, facility usage) will be evaluated as an additional cost/benefit aspect of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Bone Marrow Transplant Infection
• Chronic Disease
• Chronic Illness
• Hematologic Malignancy
• Hematologic Neoplasms
• Oncology
• Sickle Cell Disease

Intervention

Other:
• Guided Imagery
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.
• Virtual Reality
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.

Locations

Country	Name	City	State
United States	Children's Wisconsin	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Northwestern Mutual Foundation

Country where clinical trial is conducted

United States, 

References & Publications (26)

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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. — View Citation

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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. — View Citation

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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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Nilsson S, Finnström B, Kokinsky E, Enskär 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. — View Citation

Powers SW. Empirically supported treatments in pediatric psychology: procedure-related pain. J Pediatr Psychol. 1999 Apr;24(2):131-45. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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.

Zernikow B, Meyerhoff U, Michel E, Wiesel T, Hasan C, Janssen G, Kuhn N, Kontny U, Fengler R, Görtitz I, Andler W. Pain in pediatric oncology--children's and parents' perspectives. Eur J Pain. 2005 Aug;9(4):395-406. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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.
Primary	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).
Primary	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).
Primary	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	GI vs. VR in parent distress via PCS-P	GI will be compared to VR when it comes to the Pain Catastrophizing Scale for Parents (PCS-P). The PCS-P is a caregiver perspective, that consists of a 13-question survey that assesses thoughts and feelings related to children's pain on a 5 point scale ranging from "not at all" to "extremely."	The PCS-P will be completed by the caregiver 10 minutes before the first procedure or intervention.
Secondary	GI vs. VR in parent distress via Emotional Adjective Survey	GI will be compared to VR when it comes to the Emotion Adjective Survey. The Emotion Adjective Survey is a measure of caregiver distress that asks for a rating of distress across four emotional experiences (worried, upset, anxious, sad).	The Emotion Adjective Survey will be completed by the caregiver 10 minutes after each intervention.
Secondary	GI vs VR in hospital resource utilization via Staff Time	GI will be compared to VR when it comes to Staff Time. This tracking log keeps track of the total number and time (minutes) that nursing staff spend in the patient room during each procedure.	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.
Secondary	GI vs VR in hospital resource utilization via Procedure Time	GI will be compared to VR when it comes to Procedure Time. This tracking log keeps track of the total time that it takes nursing to complete the procedure.	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/
Secondary	Nurse Feasibility and Acceptability	Nurses will complete a brief measure assessing feasibility, acceptability, and expectations for success.	The Nurse Feasibility and Acceptability survey will be completed within one day following completion of each intervention.