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Relationship Between Food Insecurity and Child Dental Anxiety (FI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186689
Recruitment Status : Suspended (COVID -19 pandemic)
First Posted : December 5, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
dina darwish, Ain Shams University

Brief Summary:
identifying children with dental anxiety among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior.

Condition or disease Intervention/treatment
Food Insecurity Child Dental Anxiety Maternal Psychological Distress Other: Routine Dental Examination

Detailed Description:

A well-trained investigator will collect data on maternal age (in years), the marital status, the educational levels of both parents and their employment status, pregnancy information, as well as family structure (whether children are living with both parents or not), number of siblings (none, one, two, or ≥three). Information on family monthly income and crowding index which is defined as the average number of people per room, excluding both the kitchen and bathrooms will be also obtained.

The level of household food insecurity will be determined using the validated Arabic version of the Household Food Insecurity Access Scale (HFIAS) which categorizes food insecurity into three levels (food secure , marginally food secure and food insecure) where the final score is given according to the sum of affirmative responses to the tool statements and the higher the score the more the level of food insecurity.

The validated Arabic version of the 14-item Perceived Stress Scale will be used to measure the self-reported level of stress among mothers of the enrolled children by assessing their feelings and thoughts during the last month. The level of child's dental anxiety will be assessed during the initial oral examination before starting any dental treatment procedures using the six-point Venham behavior rating scale which ranges from total cooperation (0) to no cooperation

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Relationship Between Food Insecurity, Maternal Psychological Status, and Child Dental Behavior: A Cross-Sectional Study
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
children in fully food secure households (G1)
preschool children live in a fully food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
Other: Routine Dental Examination
Routine dental examination for the pre-school children Questionnaire for their mothers

children in marginally food secure households (G2)
preschool children live in a marginally food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
Other: Routine Dental Examination
Routine dental examination for the pre-school children Questionnaire for their mothers

children in food insecure households (G3)
preschool children live in a food-insecure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience.
Other: Routine Dental Examination
Routine dental examination for the pre-school children Questionnaire for their mothers




Primary Outcome Measures :
  1. A six-point Venham Behavior Rating Scale to evaluate the child behavior during dental examination scale score from(0)the best outcome to (6) worst outcome [ Time Frame: 6 months ]
    which ranges from total cooperation (0) to no cooperation(6)

  2. questionnaire containing 2 scales Household Food Insecurity Access Scale( score food secure better outcome -severely food insecure the worst outcome) and 14-item Perceived Stress Scale (scores from 0 better outcome to 40 worst outcome) [ Time Frame: 6 months ]
    to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
study populations are healthy pre-school children( 3.5-6 years old)having at least one tooth needs dental treatment, accompanied by their mothers.
Criteria

Inclusion Criteria:

  • the selected children accompanied by their mother should fulfill the following inclusion criteria:

    • Age range 3.5-6 years
    • Having at least one tooth with dental caries indicated for dental treatment under local anesthesia other than extraction
    • Visiting the dental clinic for the first time

Exclusion Criteria:

  • Children with the following criteria will be totally excluded from the study: Have any medical/neurological, communicative or developmental disorders as well as children with special healthcare needs.

Information from the National Library of Medicine

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): NCT04186689


Locations
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Egypt
Faculty of Dentistry- Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
dina darwish
Investigators
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Principal Investigator: Dina D Abd-Elmoneam, masters Ain Shams University
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Responsible Party: dina darwish, principle investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT04186689    
Other Study ID Numbers: 829
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the exact plan to share individual participant data (IPD) is still not formulated, once it is ready I will share.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders