Recording Facial Expressions to Assess Taste in Children and Teenagers
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|ClinicalTrials.gov Identifier: NCT02923908|
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment|
|Facial Expression||Other: Noldus Facereader 7 Other: Voice Recording Other: 5-Point Facial Hedonic Scale Other: Follow-Up Questionnaire|
Participants will taste three different substances in random order: 1. Prednisone liquid (a commonly used medicine to treat swelling which is approved by the Food and Drug Administration) for use in children; 2. A solution of table sugar in water (simple syrup); and 3. Ora-Plus, which is a solution that can be added to medicines. Ora-Plus is considered safe for use in children's formulas and all of the ingredients of Ora-Plus are on the Food and Drug Administration (FDA) Generally Regarded as Safe (GRAS) list. About 1 ml of each substance will be placed directly onto the tongue. Each substance will be tasted for 5-10 seconds and then, expectorated. Participants and investigators recording responses will be blinded with regard to the identity of test substances.
Facial expression will be recorded prior to administration of the taste substances and for approximately 2 minutes thereafter. An audio recording of the participant's voice will also be made during this time. At about 5 and 10 minutes after a given taste substance is administered, participants will be asked to identify a face on a 5-point facial hedonic scale which shows the participant's taste perception. Participants will also be asked to describe the taste sensation experienced as sweet, bitter or neutral (no apparent taste).
Participants will have a 30-minute rest period after administration of each taste substance which will include the administration of water and a neutral food to enable cleansing of the palate. The procedure above will be repeated in the same way for each of the 3 test substances.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||A Pilot Study of Facial Recognition Software to Assess Palatability in Pediatric Patients|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||June 1, 2017|
|Actual Study Completion Date :||June 1, 2017|
- Other: Noldus Facereader 7
A video recording of a subject's facial expressions while tasting a sweet, bitter, and neutral flavored liquid will be analyzed using Noldus Facereader 7 software.
- Other: Voice Recording
A voice recording will be made for the duration of the tasting period.
- Other: 5-Point Facial Hedonic Scale
A 5-point facial hedonic scale will be given to the participant to complete prior to the administration of any test substances and about 5, 10, and 30 minutes after the administration of each test substance.
- Other: Follow-Up Questionnaire
Participants will be asked a few questions about each test agent after tastings.
- Evidence that recording of facial expressions can reliably distinguish between liquids that taste bitter, sweet, or have no taste [ Time Frame: within one year of study procedure ]The investigators propose that Noldus Facereader 7 can adequately discriminate between bitter, sweet, and neutral tastes in children and adolescents. Data collected through these recordings will be compared to ratings of liking/disliking of liquids using a 5-point facial hedonic scale and compared to a questionnaire after each tasting.
- Audio Recording During Study Procedure [ Time Frame: within one year of study procedure ]An audio recording will occur during the tasting of each liquid in order to capture the subject's response to the liquid. This recording will be analyzed to determine a subject's liking/disliking of each test agent.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923908
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Gregory L Kearns, PharmD, PhD||Arkansas Children's Research Institute|