Clinical trial NCT04892160: Distracting Through Procedural Pain and Distress
Official title: Comparison of Guided Imagery and Virtual Reality (VR) Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Hematologic Malignancy
Bone Marrow Transplant Infection
Oncology
Sickle Cell Disease
Keywords: Procedural Pain
Anxiety
Pediatric
Virtual Reality
Guided Imagery
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Northwestern Mutual Foundation
First posted: 2021-05-19
Enrollment: 67
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: GI vs. VR in patient pain via the Pain Catastrophizing Scale (PCS)
timeFrame: The PCS will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).
measure: GI vs. VR in patient pain via the Visual Analogue Scale (VAS)
timeFrame: The VAS will be completed by the patient within 10 minutes after completion of each intervention (i.e., GI and VR intervention).
measure: GI vs. VR in patient pain via Children's Emotional Manifestation of Pain Scale (CEMS)
timeFrame: 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.
measure: GI vs. VR in patient anxiety via State Trait Anxiety Inventory - Trait (STAI-T)
timeFrame: The STAI-T will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).
measure: GI vs. VR in patient anxiety via STAI-State Pre-Intervention
timeFrame: STAI-State will be completed 10 minutes prior to the first and second procedure (GI and VR).
measure: GI vs. VR in patient anxiety via STAI-State Post-Intervention
timeFrame: STAI-State will be completed 10 minutes after the first and second intervention (GI and VR).
Secondary outcomes:
measure: GI vs. VR in parent distress via PCS-P
timeFrame: The PCS-P will be completed by the caregiver 10 minutes before the first procedure or intervention.
measure: GI vs. VR in parent distress via Emotional Adjective Survey
timeFrame: The Emotion Adjective Survey will be completed by the caregiver 10 minutes after each intervention.
measure: GI vs VR in hospital resource utilization via Staff Time
timeFrame: 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.
measure: GI vs VR in hospital resource utilization via Procedure Time
timeFrame: 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/
measure: Nurse Feasibility and Acceptability
timeFrame: The Nurse Feasibility and Acceptability survey will be completed within one day following completion of each intervention.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
city: Wauwatosa
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jennifer Hoag, PhD
role: PRINCIPAL_INVESTIGATOR
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