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Assessing Environmental Factors in Healthcare Facilities in Order to Improve the Experience of Patients, Staff, and the Quality of Imaging Procedures

Not Applicable
Active, not recruiting
Conditions
Healthcare Facility Environment - Imaging
Interventions
Other: Light perception
Other: Sound perception
Other: Smell perception
Other: Vibration perception
Other: Voice activation
Registration Number
NCT03456895
Lead Sponsor
University of Cincinnati
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
15
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Healthy volunteer populationLight perceptionHealthy 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)
Healthy volunteer populationSmell perceptionHealthy 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 populationVibration perceptionPatient 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 populationSound perceptionStaff 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.
Staff populationVoice activationStaff 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.
Healthy volunteer populationVibration perceptionHealthy 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 populationSmell perceptionPatient 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.
Healthy volunteer populationSound perceptionHealthy 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 populationSound perceptionPatient 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 populationVibration perceptionStaff 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.
Healthy volunteer populationVoice activationHealthy 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 populationLight perceptionPatient 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 populationLight perceptionStaff 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.
Staff populationSmell perceptionStaff 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.
Patient populationVoice activationPatient 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.
Primary Outcome Measures
NameTimeMethod
Mood, Self-ReportParticipants may complete surveys through study completion, on average 1 year.

Participants' mood will be assessed via self report in surveys

Mood, Physiological State - Body TemperatureParticipants may complete physiological measurements through study completion, on average 1 year.

Participants' mood will be assessed via participants' body temperature

Feasibility of the use of voice activation within the imaging environmentWe will be observing the feasibility of voice activation through study completion, on average 1 year.

We are observing how practical and beneficial it is to use voice activation technologies such as Amazon Echo, Google home or similar devices within the imaging environment. For instance, we will observe how user-friendly, time-consuming, etc. the use of voice activation technology is within an imaging setting for assessing participant preferences.

Mood, Physiological State - Heart RateParticipants may complete physiological measurements through study completion, on average 1 year.

Participants' mood will be assessed via measurements of participants' heart rate

Environmental preferenceParticipants may complete surveys through study completion, on average 1 year.

Participants will self-report their preferences for different light, sound, smell, and vibration sensations

Secondary Outcome Measures
NameTimeMethod
MotionMotion of each participant may be monitored from the time the participant begins the environmental experience until the participant completes study procedures, up to roughly 1 hour

We will use short wave radar to perform positional monitoring of subjects during the observational period. This short-wave radar will be used as a means to assess motion and detect subject movement in a room that we hope to correlate to their level of comfort and relaxation. Short wave radar is also technically able to detect very miniscule motion including blood flow and pulse rate, which would allow us to move away from wearable devices to remote sensing devices further hoping to increase patient comfort. No short wave radar devices will be used during the imaging examination.

TemperatureTemperature of the environment and of each participant may be monitored from the time the participant begins the environmental experience until the participant completes study procedures, up to roughly 1 hour

We will use infrared detector camera technology to assess the skin temperature of subjects at different body regions and changes during the observational period. This will also be used to determine the temperature of the surroundings as well, for example, to determine the relative temperature of the chair and the imaging bed. Infrared cameras installed alongside the normal surveillance cameras to monitor patients during the imaging examination may also be used to monitor the temperature of the surroundings as well as the body to determine if that may be the reason for motion.

Quality of imaging studyImage quality will be assessed after SOC images are collected from patient participants through study completion, on average 1 year.

Patient participants who have given authorization for a blinded review of their imaging study will have their imaging study reviewed on a radiological image review workstation and assessed by an experienced reader of imaging studies in regard to the presence and severity of artifacts. Those findings will be recorded both in a structured and free text form using a survey tool. We anticipate that in this exploratory study observations will be made that will lead to the need to further detail and/or refine structured recording of the findings.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center

🇺🇸

Columbus, Ohio, United States

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