FI: Relationship Between Food Insecurity and Child Dental Anxiety

Sponsor
dina darwish (Other)
Overall Status
Recruiting
CT.gov ID
NCT04186689
Collaborator
(none)
300
1
5.4
56

Study Details

Study Description

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 Phase
  • 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

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 20, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Months to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry- Ain Shams University Cairo Egypt

Sponsors and Collaborators

  • dina darwish

Investigators

  • Principal Investigator: Dina D Abd-Elmoneam, masters, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
dina darwish, principle investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04186689
Other Study ID Numbers:
  • 829
First Posted:
Dec 5, 2019
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2020