Pain Clinical Trial
Official title:
Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures
This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing painful procedures in Phlebotomy, Radiology, Infusion, Orthopedics, Gastroenterology, and Immunology, amongst others, at CHLA, as measured by self- and proxy-report. Examples of the painful procedures include IV sticks, cast removals, allergy testing, and anorectal manometries.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | December 6, 2025 |
Est. primary completion date | December 6, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 21 Years |
Eligibility | Inclusion Criteria: Inclusion Criteria for Children: 1. Children who are 7-21 years old 2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking) 3. Children who are undergoing a painful medical procedure (e.g., venipuncture, IV placement, PICC lines, wound care, cast removal, botox injections) are eligible to participate in this project. 4. Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters. Inclusion criteria for healthcare providers: 1. Healthcare providers must be 18 years old or older 2. Healthcare providers must be Children's Hospital Los Angeles staff 3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure Exclusion Criteria: 1. Children who are currently taking pain medication or anxiolytic medication will be excluded from this study. 2. Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders 3. Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks 4. Children with a history of seizure disorder. 5. Children currently sick with flu-like symptoms or experiencing a headache or earache. 6. Children with known or suspected motion sickness |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | AppliedVR Inc. |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic Survey | A brief demographic survey will be administered to parent regarding their child's age, ethnicity, grade in school, and any medical conditions or learning problems they may have. | Approximately 5 minutes to one hour before procedure | |
Primary | VAS | VAS anticipatory anxiety measure: The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children. | Approximately 5 minutes to one hour before procedure | |
Primary | Faces Pain Scale (FPS-R) | Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity. | Approximately 5 minutes to one hour before procedure | |
Primary | Facial Affective Scale | A faces scale to predict pediatric pain unpleasantness. | Approximately 5 minutes to one hour before procedure | |
Primary | Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older | CASI is an 18-item scale that measures the tendency to view anxiety-related bodily sensations as dangerous (e.g., ''It scares me when my heart beats fast''). Items are scored on a 3-point scale (none, some, a lot), and total scores are calculated by summing all items. The CASI has demonstrated high internal consistency and adequate test-retest reliability. The CASI correlates well with measures of trait anxiety but also accounts for variance in fear not attributable to trait anxiety measures | Approximately 5 minutes to one hour before procedure | |
Primary | Malaise Scale | The MS is a six-point scale indicating level of nausea from (1) no symptoms to (6) being sick The MS is completed before and after administration of the VR game to monitor for any signs of nausea. Instructions to the child are as follows: "This is a scale from one to six. One means that you feel fine and no different to how you normally feel. Two means that you feel a little bit different or funny but not sick in the tummy. Three means that you feel a little bit sick and four means that you feel more than a little bit sick but not really sick. Five means that you feel really sick, like you are going to throw up or vomit and six means that you are being sick or vomiting. I'm going to ask you every few minutes how you feel. I want you to tell me which number from one to six best describes how you feel at that time." | Approximately 5 minutes to one hour before procedure | |
Primary | Child Presence Questionnaire | The Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience. This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format. Items assess the child's sense of involvement, realism, and transportation into the experience. Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion. | Approximately 5-15 minutes after procedure | |
Primary | Child Satisfaction Survey | The child survey is 13-item, Likert-like survey to assess child estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction; it mirrors the parent survey. There are two versions, one for each treatment condition. Two versions of the survey exist, to account for condition (VR vs. standard of care). | Approximately 5-15 minutes after procedure | |
Primary | Parent Satisfaction Survey | The parent survey is 16-item, Likert-like survey to assess parent estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction. Two versions of the survey exist, to account for condition (VR vs. standard of care). | Approximately 5-15 minutes after procedure | |
Primary | Healthcare Provider Survey | The healthcare provider survey is a 7-item Likert-like investigator-developed survey to assess their estimates of pain and anxiety management, cooperation, and satisfaction with the procedure. Healthcare providers are also invited to write comments about the use of VR (if applicable) during the IV placement procedure. | Approximately 5-15 minutes after procedure | |
Primary | VAS | VAS anticipatory anxiety measure: The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children. | Approximately 5-15 minutes after procedure | |
Primary | Faces Pain Scale (FPS-R) | Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity. | Approximately 5-15 minutes after procedure | |
Primary | Facial Affective Scale | A faces scale to predict pediatric pain unpleasantness. | Approximately 5-15 minutes after procedure | |
Primary | Malaise Scale | The MS is a six-point scale indicating level of nausea from (1) no symptoms to (6) being sick The MS is completed before and after administration of the VR game to monitor for any signs of nausea. Instructions to the child are as follows: "This is a scale from one to six. One means that you feel fine and no different to how you normally feel. Two means that you feel a little bit different or funny but not sick in the tummy. Three means that you feel a little bit sick and four means that you feel more than a little bit sick but not really sick. Five means that you feel really sick, like you are going to throw up or vomit and six means that you are being sick or vomiting. I'm going to ask you every few minutes how you feel. I want you to tell me which number from one to six best describes how you feel at that time." | Approximately 5-15 minutes after procedure | |
Secondary | CAMPIS-R | The CAMPIS-R is a standardized rating scale that codes videotaped verbal interactions in the pediatric treatment room. The CAMPIS-R codes the subject, speaker, phase of medical procedure, verbal content, affective tone, and to whom vocalizations are directed. Adult vocalizations are coded as coping-promoting (nonprocedural talk or humor directed to the child, commands to engage in coping strategies), distress-promoting (reassuring comments, apologies, giving control to the child, criticism, and empathetic statements), or neutral (humor to adults, nonprocedural talk to adults, child's condition talk, commands for procedural activity, praise, notification of procedure to come, behavioral commands to child, checking child's status). Two independent study team coders will complete the CAMPIS-R while reviewing the videotape from each of the I&D of abscess procedures. | Peri-procedure |
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