Distracting Through Procedural Pain and Distress
NCT04892160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2021-05-19
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
Interventions
- 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.
- OTHER
-
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.
Sponsors & Collaborators
-
Northwestern Mutual Foundation
collaborator UNKNOWN -
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Jennifer Hoag, PhD · Medical College of Wisconsin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 8 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-15
- Primary Completion
- 2019-04-29
- Completion
- 2019-04-29
Countries
- United States
Study Locations
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