Chronic IllnessNCT04892160
Distracting Through Procedural Pain and Distress
A study testing Guided Imagery and Virtual Reality in people with Chronic Illness and Hematologic Malignancy, run by Medical College of Wisconsin at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Chronic Illness, Hematologic Malignancy, Bone Marrow Transplant Infection
- What is being tested?
- Guided Imagery and Virtual Reality
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2018to 29 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
Official title: Comparison of Guided Imagery and Virtual Reality (VR) Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures
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.
Read the 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.
- Conditions
- Chronic Illness, Hematologic Malignancy, Bone Marrow Transplant Infection, Oncology, Sickle Cell Disease
- Being tested
- Guided Imagery, Virtual Reality
- Keywords
- Procedural Pain, Anxiety, Pediatric, Virtual Reality, Guided Imagery
- Medical subject headings
- Chronic Disease, Hematologic Neoplasms, Neoplasms, Anemia, Sickle Cell, Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryOther
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 RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Guided Imagery; Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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."
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
Nurses will complete a brief measure assessing feasibility, acceptability, and expectations for success.
Measured: The Nurse Feasibility and Acceptability survey will be completed within one day following completion of each intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Feb 2018
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Mutual Foundation
- Responsible party
- Principal investigator, Jennifer Hoag, Medical College of Wisconsin
- Investigators
- Jennifer Hoag, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892160
- Sponsor's protocol ID
- 1110230
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will only share de-identified data for researchers who would like to do a secondary analysis.
Publications
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.
PubMed 23277857Blount, 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.
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.
PubMed 18020853Das 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.
PubMed 15745448Deraney 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.
PubMed 28927519Gershon 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.
PubMed 14756933Gershon 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.
PubMed 15381891Gold, 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.
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.
PubMed 10692634Jeffs 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.
PubMed 24823326Kazak 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.
PubMed 9651414Koller 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.
PubMed 21925588Malloy 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.
PubMed 20691523Mosadeghi 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.
PubMed 27349654Nilsson 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.
PubMed 19230769
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Guided Imagery and Virtual Reality (VR) Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures
- ClinicalTrials.gov ID
- NCT04892160
- Acronym / sponsor ID
- 1110230
- Conditions
- Chronic Illness, Hematologic Malignancy, Bone Marrow Transplant Infection, Oncology, Sickle Cell Disease
- Keywords
- Procedural Pain, Anxiety, Pediatric, Virtual Reality, Guided Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Northwestern Mutual Foundation
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery First/Virtual Reality Second | Other | Other: Guided Imagery, Other: Virtual RealityPatients 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. |
| Virtual Reality First/Guided Imagery Second | Experimental | Other: Guided Imagery, Other: Virtual RealityPatients 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. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryUpon 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 | Guided Imagery First/Virtual Reality Second, Virtual Reality First/Guided Imagery Second |
| Virtual RealityUpon 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. | Other | Guided Imagery First/Virtual Reality Second, Virtual Reality First/Guided Imagery Second |
Primary outcome
GI vs. VR in patient pain via the Pain Catastrophizing Scale (PCS)
Time frame: The PCS will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).
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."
GI vs. VR in patient pain via the Visual Analogue Scale (VAS)
Time frame: The VAS will be completed by the patient within 10 minutes after completion of each intervention (i.e., GI and VR intervention).
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.
GI vs. VR in patient pain via Children's Emotional Manifestation of Pain Scale (CEMS)
Time frame: 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 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.
GI vs. VR in patient anxiety via State Trait Anxiety Inventory - Trait (STAI-T)
Time frame: The STAI-T will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).
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.
GI vs. VR in patient anxiety via STAI-State Pre-Intervention
Time frame: STAI-State will be completed 10 minutes prior to the first and second procedure (GI and VR).
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.
GI vs. VR in patient anxiety via STAI-State Post-Intervention
Time frame: STAI-State will be completed 10 minutes after the first and second intervention (GI and VR).
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.
5 secondary outcomes
GI vs. VR in parent distress via PCS-P
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The Nurse Feasibility and Acceptability survey will be completed within one day following completion of each intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 23277857Asl 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.
- 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.
- Background: PubMed 18020853Dahlquist 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.
- Background: PubMed 15745448Das 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.
- Background: PubMed 28927519Deraney 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.
- Background: PubMed 14756933Gershon 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.
- Background: PubMed 15381891Gershon 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.
- BackgroundGold, 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: PubMed 10692634Hoffman 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.
- Background: PubMed 24823326Jeffs 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.
- Background: PubMed 9651414Kazak 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.
- Background: PubMed 21925588Koller 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.
- Individual participant dataSharing planned: Yes. We will only share de-identified data for researchers who would like to do a secondary analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hoag, PhD principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Virtual Reality in people with Chronic Illness and Hematologic Malignancy, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI vs. VR in patient pain via the Pain Catastrophizing Scale (PCS) (time frame: The PCS will be completed by the patient 10 minutes before the first procedure or intervention (i.e., at baseline).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892160, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.