Behaviors and Mental Disorders

All Conditions

Infections

Symptoms and General Pathology

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Rare Diseases

Anxiety Disorders

Chronic Disease

Anemia, Sickle Cell

Hematologic Neoplasms

Communicable Diseases

Pain

Pain, Procedural

Anemia

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hematologic Diseases

Hemoglobinopathies

Genetic Diseases, Inborn

Disease Attributes

Chronic Graft Versus Host Disease

Sickle Cell Anemia

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.

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.

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.

Guided Imagery

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.

Virtual Reality

Jennifer Hoag, PhD

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.

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.

Distracting Through Procedural Pain and Distress

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

We will only share de-identified data for researchers who would like to do a secondary analysis.

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 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 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 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 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 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."

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).

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.

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.

Nurses will complete a brief measure assessing feasibility, acceptability, and expectations for success.

Northwestern Mutual Foundation

Medical College of Wisconsin

Associate Professor of Pediatrics

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Adding a non-painful event after the most uncomfortable phase of Pap smear.

Traditional Pap-smear procedure as control.

Adding a non-painful step after the most uncomfortable phase of Pap smear

Modified Pap test

Chien-Hsieh Chiang, MD, MPH

To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. This study aims to conduct a randomized controlled study at a tertiary center, National Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain intensity of the intervention and control groups.

Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. Methods: This study aims to conduct a randomized controlled study at NTUH. Approximately 200 subjects are expected to be recruited. The investigators will utilize the peak-end rule by adding a non-painful step right after the most uncomfortable phase in the intervention group. All study subjects are requested to score on a numeric pain scale during the Pap test. All operators experienced in techniques for performing a Pap test should attend workshops for a standard operating procedure. A well-trained research assistant is also responsible for ensuring standardization of procedures to eliminate interoperator variability. The primary outcome was the recalled pain intensity at five minutes after the Pap smear test.

Subjects are divided into two groups, one with traditional Pap smear and one with Pap smear adding a non-painful procedure at the end. The investigators will compare the real-time pain score and recalled pain to check whether the theory works.

During the Pap test, there is a privacy curtain separating participants from the operators. Participants receiving the modified Pap test do not realize what is going on during the 15-second step because they are behind the privacy curtain. The operators performing the procedure are not informed whether to intervene or not by the assistants until a specimen is prepared for cervical cytology. The delayed disclosure of the group allocation until this step ensures the operators standardizing the insertion and opening phases of the Pap test.

Ameliorating the Obstacle of Pap Smear

Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial

This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).

This recalled pain intensity is evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain), where pain was categorized as mild, moderate, and severe.

The participants are asked to evaluate and record their pain every five seconds throughout the test. The real-time pain is recorded with a 1 to 5 numeric scale (1:no pain; 5: maximal) at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course in all participants; as well as right after the additional 15-second step in the group receiving modified Pap tests. The average pain, the maximal pain, as well as real-time pain at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course are compared between the two groups. For each group, we also compare the average pain of the first half and the second half of the total course. For participants receiving the modified Pap test, we further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.

Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).

Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).

0-10 grades (0: unwillingness; 10: highest grade of willingness)

National Taiwan University Hospital

Nervous System Diseases

Mental Disorders

Psychotic Disorders

Neurologic Manifestations

Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.

Urs Mücke, Dr.

Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.

In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial

Parents and patients were given different statements

Involved staff were asked about experience/feedback

Hannover Medical School

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Anesthetics

Nitrous Oxide

Anesthetics, Local

Analgesics, Opioid

Lidocaine, Prilocaine Drug Combination

Anti-Anxiety Agents

30 patients will be included in the virtual reality arm

30 patients will be included the usual practices

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine

Usual Practices

Amandine AF FERNANDES

Karine KG ESTEVE-GARNIER

Amandine FERNANDES

This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children with cancer. Patients age from 7 to under 18 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.

Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices.

After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.

This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.

Impact of Virtual Reality in Pediatric Hematology and Oncology

Impact of Virtual Reality in Pediatric Hematology and Oncology for the Management of Pain During Invasive Procedures in Children 7 to Under 18 Years in a Pilot Study

At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber.

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Pain from the VAS after the 1st connection to the implantable chamber:

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

The Frankl scale, is a scale of hetero-evaluation of anxiety. It will be performed by the caregiver before the invasive procedure (lumbar puncture and connection to an implantable chamber). It is suitable for children from 7 to under 18 years old and is easy to score:

* 0: Definitely negative behavior; refuses treatment, shouts forcefully, opposes/cares,
* 1: Negative behavior: unwilling to accept care; unwilling to accept care. Some signs of opposition exist but not necessarily declared (sullen air, scowling),
* 2: Positive behaviour; accepts treatment with reservation. He is cautious but follows the instructions of the practitioner/caregiver
* 3: Definitely positive behavior; good relations/practitioner/caregiver, interested in treatment. He laughs often and seems to enjoy the visit/care.

The type of associated analgesics, the dosage will be collected through the patient's medical record

Heart rate (min \<40 B/min - max \>200 B/min), from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

oxygen saturation (min \<90% - max \>100%) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

Respiratory rate (min \<10 - max \> 50) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

Tolerance, in number of episodes of confusion, agitation, dizziness, nausea, vomiting, headache, hallucinations and temporary amnesia during the performance of the invasive act and within 2 hours of post-act monitoring for a lumbar puncture and 30 minutes for a connection to an implantable chamber

A patient may have several consecutive invasive acts. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Pain from the VAS after the 1st connection to an implantable chamber the :

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Distracting Through Procedural Pain and Distress	NCT04892160	Chronic Illness Hematologic Mal... Bone Marrow Tra... Oncology Sickle Cell Dis...	Guided Imagery Virtual Reality	8 Years - 25 Years	Medical College of Wisconsin
Ameliorating the Obstacle of Pap Smear	NCT04420208	Pain	Modified Pap te...	30 Years - 70 Years	National Taiwan University Hospital
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic	NCT06235723	Pediatric Cance... Procedural Anxi... Procedural Pain	Virtual Reality	6 Years - 18 Years	Hannover Medical School
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital

Spots Global Cancer Trial Database for procedural pain