Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04186689
Other study ID # 829
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2020
Est. completion date June 2021

Study information

Verified date December 2020
Source Ain Shams University
Contact Dina D Abd-Elmoneam, masters
Phone 01008081740
Email dinadarwish@dent.asu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 2021
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Months to 6 Years
Eligibility 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.

Study Design


Intervention

Other:
Routine Dental Examination
Routine dental examination for the pre-school children Questionnaire for their mothers

Locations

Country Name City State
Egypt Faculty of Dentistry- Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
dina darwish

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 which ranges from total cooperation (0) to no cooperation(6) 6 months
Primary 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) to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT06313112 - Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India
Completed NCT03436589 - The Indiana SNAP-Ed Long-term Study N/A
Completed NCT03026608 - Green Cart Program Evaluation N/A
Recruiting NCT06019624 - Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes N/A
Recruiting NCT05745376 - Addressing Disparities in Food Access Among Young Children in Louisiana: A Farm to ECE Approach N/A
Active, not recruiting NCT05601804 - TARGETing Healthy Weight Loss in the Context of Food Insecurity
Recruiting NCT05208671 - Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma N/A
Active, not recruiting NCT05048836 - Healthy Food First N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Not yet recruiting NCT06298253 - Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 N/A
Active, not recruiting NCT00821366 - Effective Aids Treatment and Support in the Free State (FEATS) Phase 3
Active, not recruiting NCT05424367 - Food Environment, Food Insecurity, and Health Behaviors in NH Hispanics
Completed NCT03847662 - Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Not yet recruiting NCT05854212 - Behavioral Economics to Implement Nutrition Ranking in Food Pantries N/A
Withdrawn NCT04017624 - Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO N/A
Completed NCT05076487 - Effects of Episodic Food Insecurity in African American Women With Obesity
Not yet recruiting NCT06116422 - Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health N/A
Terminated NCT04968496 - Biobehavioral Mechanisms of Food Insecurity N/A
Not yet recruiting NCT06415370 - Food and Friends: Healthy Meals Delivered to You N/A
Completed NCT02925429 - PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda