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

NCT ID: NCT03456895

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2024-12-31

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.

Conditions

Healthcare Facility Environment - Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Healthy volunteer population

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)

Group Type: EXPERIMENTAL

Light perception

Intervention Type: 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.

Sound perception

Intervention Type: 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.).

Smell perception

Intervention Type: 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.

Vibration perception

Intervention Type: 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.

Voice activation

Intervention Type: 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.

Patient population

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.

Group Type: EXPERIMENTAL

Light perception

Intervention Type: 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.

Sound perception

Intervention Type: 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.).

Smell perception

Intervention Type: 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.

Vibration perception

Intervention Type: 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.

Voice activation

Intervention Type: 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.

Staff population

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.

Group Type: EXPERIMENTAL

Light perception

Intervention Type: 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.

Sound perception

Intervention Type: 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.).

Smell perception

Intervention Type: 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.

Vibration perception

Intervention Type: 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.

Voice activation

Intervention Type: 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.

Interventions

Light perception

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.

Intervention Type: OTHER

Sound perception

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.).

Intervention Type: OTHER

Smell perception

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.

Intervention Type: OTHER

Vibration perception

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.

Intervention Type: OTHER

Voice activation

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio Third Frontier

OTHER

Sponsor Role: collaborator

Wright Center of Innovation in Biomedical Imaging

UNKNOWN

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Michael V Knopp MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael V Knopp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32530434 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2017H0266/RP0525

Identifier Type: -

Identifier Source: org_study_id