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

NCT03456895 | Unknown

• 1 other identifier: 2017H0266/RP0525
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare Facility Environment - Imaging

Outcome Measures

Primary Outcomes (5)

• Mood, Physiological State - Heart Rate

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

  Participants may complete physiological measurements through study completion, on average 1 year.

• Mood, Physiological State - Body Temperature

  Participants' mood will be assessed via participants' body temperature

  Participants may complete physiological measurements through study completion, on average 1 year.

• Mood, Self-Report

  Participants' mood will be assessed via self report in surveys

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

• Environmental preference

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

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

• Feasibility of the use of voice activation within the imaging environment

  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.

  We will be observing the feasibility of voice activation through study completion, on average 1 year.

Secondary Outcomes (3)

• Temperature

  Temperature 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

• Motion

  Motion 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

• Quality of imaging study

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

Study Arms (3)

Healthy volunteer population

EXPERIMENTAL

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)

Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation

Patient population

EXPERIMENTAL

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.

Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation

Staff population

EXPERIMENTAL

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.

Other: Light perception; Other: Sound perception; Other: Smell perception; Other: Vibration perception; Other: Voice activation

Interventions

Light perception OTHER

We will be using Wi-Fi/IP programmable LED lighting systems that will replace conventional lighting systems and may be in canned lights, spot lights, light chains or table lights. These lighting systems can be fully controlled by web based applications on smart phones tablets and computer systems and can be combined with input systems such as switches, motion detection or voice activated. Differences in lighting perception will be explored by varying lighting color and brightness.

Healthy volunteer population; Patient population; Staff population

Sound perception OTHER

We will be using Wi-Fi/Bluetooth addressable sound systems that will be linked with sound sources such as media players on smart devices or computer systems. Differences in sound perception will be explored by varying sound types (i.e. different music types, ambient noise, etc.).

Healthy volunteer population; Patient population; Staff population

Smell perception OTHER

We will explore the use of consumer grade ventilation systems that can be equipped to distribute packaged scents. Differences in smell perception will be explored by varying the types of scents.

Healthy volunteer population; Patient population; Staff population

Vibration perception OTHER

We will explore the use of chairs or blankets that enable subjects to perceive vibrations. An initial implementation will be the use of on relaxing/massage chair that enables the experience of vibration sensation in the back or leg area. We may use also potentially vibration blankets in the arm or neck area. Differences in vibration perception will be explored by varying the location, frequency, etc. of vibrations with the subject being placed in a chair on an imaging table/bed.

Healthy volunteer population; Patient population; Staff population

Voice activation OTHER

We will explore the use and linkage of voice activation system such as Amazon Echo, Google home or similar devices. Some participants may be asked to use voice activations to verbally select and/or change the environmental settings according to their preferences. We are evaluating the feasibility of voice activation with the imaging environment.

Healthy volunteer population; Patient population; Staff population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Ohio Third Frontier: collaborator
• Wright Center of Innovation in Biomedical Imaging: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Related Publications (1)

• Knopp MU, Binzel K, Wright CL, Zhang J, Knopp MV. Enhancing Patient Experience With Internet Protocol Addressable Digital Light-Emitting Diode Lighting in Imaging Environments: A Phase I Study. J Med Internet Res. 2020 Jun 12;22(6):e11839. doi: 10.2196/11839.

  PMID: 32530434 DERIVED

MeSH Terms

Interventions

Auditory Perception; Smell

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael V Knopp, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three populations are being investigated in this trial; a healthy volunteer population, a patient population, and a staff population. Each population has the potential to participate in survey tools and/or physical environmental experiences.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: March 7, 2018
• Study Start: December 5, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)