| Registry | NCT03456895 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, health services research |
| Enrollment | 15 (Actual) |
| Sponsor | University of Cincinnati (Other); collaborators: Ohio Third Frontier, Wright Center of Innovation in Biomedical Imaging |
| Conditions | Healthcare Facility Environment - Imaging |
| Interventions | Light perception, Sound perception, Smell perception, Vibration perception, Voice activation (Other) |
| Dates | start 2017-12-05, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2018-03-07, last updated 2024-01-18 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthcare Facility Environment - Imaging All trials of Light perception All trials of Sound perception
The purpose of this study is to assess subjects' perceptions of environmental conditions and their preferences, and to expose subjects to varied environmental conditions as well as to assess their perception and feedback to these conditions. Another aim of this study is to explore potential patterns, factors of influence, and factors of reference in relation to the objectively assessed quality of the imagining examination and/or the perception of the patient. Finally, another aim of this study is to explore the feasibility of innovative biofeedback response capturing methodologies and technologies to guide the design of specific clinical investigations or trials.
Tremendous technological advances have occurred in recent years that enable easily controlled lights, sound, temperature, airflow as well as sensatory experiences such as smell or vibrations. While in some fields, these technologies are readily used, their potential application within healthcare environments has not yet been studied. In this study, we want to investigate how environmental factors including light, sound, temperature, smell, and sensatory experiences such as vibration are being perceived by subjects to develop environmental strategies using those components to create a more relaxing, and comforting experience for patients prior, during and after an imaging examination and for staff working in such environments. This data that will also guide to encourage changes of patient staff facility interactions to further improve the healthcare experience and quality of imaging examinations. To get a complete set of data, we plan to include volunteer participants, patients scheduled for imaging examinations, and staff working in the healthcare environment. This study has up to three different components: A, filling out survey forms to learn more about the perception of experience factors B, participating in facility experiences that may expose subjects to different facility factors and will then assess responses using additional survey forms or electronic measurement and data capture devices and C, during an imaging study the environment experience may be altered and assessments will be done to determine how relaxed the subject remains during the imagining study and the degree of motion induced artifacts. Feedback data will be obtained through survey tools as well as available consumer grade wearable devices that can continuously capture physiological parameters such as heart rate, motion, body perspiration and muscle tension. Only participants in the patient, staff, or volunteer populations who are not receiving an MRI imaging examination will participate in utilizing the wearable devices, as the wearable devices are not compatible with the MRI system. Patients receiving a PET/CT examination will be able to utilize a wearable device. For patients scheduled for an imaging examination the findings and perception of environmental factors will be compared with the image quality of the imaging examination and the feedback responses.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy volunteer population | Experimental | Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation | Healthy volunteer participants will have one of two options for participation: 1. completion of an electronic survey tool to assess the perception and preference of environmental factors (virtual participation) 2. completion of the above survey and participation in environmental experiences and providing feedback about their experience (physical participation) |
| Patient population | Experimental | Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation | Patient participants will complete a survey tool and either participate in specific environmental experience testing or may be exposed to an environmental experience during the imaging examination. The imaging exam will be assessed in regard to quality factors such as motion artifacts as an indicator of being relaxed during the examination. |
| Staff population | Experimental | Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation | Staff participants who work in imaging-related healthcare environments will complete survey tools regarding their perception and preference of environmental factors and/or will participate in environmental experiences and provide feedback. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: Volunteer population: \- Male and female volunteers above the age of 18 who are able to give an informed consent or have a legal guardian able to give informed consent on their behalf Staff population: \- Male and female staff at the Ohio State University above the age of 18 who are able to give informed consent Patient population: * Male and female patients greater than or equal to 18 years of age able to give informed consent or have a guardian able to give informed consent on their behalf * Patients must have an imaging study such as an MRI, PET/CT, or CT scheduled to be performed at the Wright Center facility at Martha Morehouse Exclusion Criteria: * Unable to communicate in English * Subjects that are incapable of giving informed consent or that do not have a legal guardian to give informed consent on their behalf. * Prisoners.
| Facility | City | Country | Status |
|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus, Ohio | United States |