## Protocol Section
### Identification Module
**NCT ID:** NCT06437249

**Brief Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience

**Official Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience (Cross Sectional Study)

#### Organization Study ID Info
**ID:** children dental anxiety
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Ghadeer Jaafar Ali Jawad

**Investigator Title:** Principal Investigator Ghadeer Jaafar Ali

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Determine the relation of of Children's dental anxiety to Parental Dental anxiety, child's age and gender and caries experience will be obtained through written questionnaires (ACDAS) and (CDAS) to the child and parents of children aged 6-8 years old in the clinic.

**Detailed Description:** 1. Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire.
2. The child's age and gender will be recorded first.
3. Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter.
4. Dental caries experiences will record by using Dental caries indices (DMF and def)
5. Child dental anxiety will be evaluated from (ACDAS) Questionnaire: The first part is child self-report part, the operator will be answered by ticking the box that corresponds to child dental anxiety, 1 (happy), 2 (Ok), 3 (Scared). The second part about the cognitive part with five questions: three of them answered with (Yes, No) and the other two questions answered with score, 1 (happy), 2 (Ok), 3 (Scared)
6. Parents dental anxiety will be evaluated from (CDAS) Questionnaire. the parents will answer by ticking the answer. The final scores, \&amp;gt;9 (Mild anxiety), 9-12 (Moderate anxiety), 13-14 (High anxiety), 15-20 (Sever anxiety).
7. Results will be analyzed by the statistician.
8. Data handling will be supervised by the supervisors.

### Conditions Module

**Conditions:**

- Child Dental Anxiety

**Keywords:**

- Parental dental anxiety

- Child dental anxiety

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Month

### Outcomes Module

#### Primary Outcomes

**Description:** Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared

**Measure:** Child dental anxiety

**Time Frame:** Two months

**Description:** record Heart rate number using fingertip pulse oximeter

**Measure:** Level of anxiety

**Time Frame:** Two months

**Description:** Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition

**Measure:** Caries experience

**Time Frame:** Two months

#### Secondary Outcomes

**Description:** Using Corah Dental Anxiety Scale Questionnaire Score a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20

* \< 9 = mild
* 9 - 12 = moderate anxiety
* 13 - 14 = high anxiety
* 15 - 20 = severe anxiety (or phobia) higher score means worse

**Measure:** Parental dental anxiety

**Time Frame:** Two months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Children range in age from 6-8 years old.
2. First dental visit.
3. Accompanied by their parents.
4. Both male and female included.

Exclusion Criteria:

1. Children with Physical or mental disabilities.
2. Children who refuse to participate.

**Healthy Volunteers:** True

**Maximum Age:** 8 Years

**Minimum Age:** 6 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** 1. Gender: Male and Female.
2. Age: 6-8 years old

   * in Pediatric Clinic in Pediatric Dentistry and Dental Public Health Department-faculty of Dentistry, Cairo University, Egypt.
   * parents will be interviewed by the examiner and the questionnaire will be filled.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ghadeerja08558@gmail.com

**Name:** Ghadeer Jawad, Master

**Phone:** 00201220262599

**Phone Ext:** +97333323874

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** rasha.adel@dentistry.cu.edu.eg

- **Name:** Rasha l Adel, PHD

- **Phone:** 00201111511145

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Cairo University

**State:** Almanial

**Zip:** Egypt

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Ola Mustafa, professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** evaluate the relation between the parental dental anxiety, child age and gender and caries experience on child dental anxiety in a group of Egyptian children.

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Coric A, Banozic A, Klaric M, Vukojevic K, Puljak L. Dental fear and anxiety in older children: an association with parental dental anxiety and effective pain coping strategies. J Pain Res. 2014 Aug 20;7:515-21. doi: 10.2147/JPR.S67692. eCollection 2014.

**PMID:** 25187737

**Citation:** Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.

**PMID:** 31377

**Citation:** Al-Namankany A, Ashley P, Petrie A. The development of a dental anxiety scale with a cognitive component for children and adolescents. Pediatr Dent. 2012 Nov-Dec;34(7):e219-24.

**PMID:** 23265158

**Citation:** Aditya PVA, Prasad MG, Nagaradhakrishna A, Raju NS, Babu DN. Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial. Heliyon. 2021 Sep 29;7(9):e08092. doi: 10.1016/j.heliyon.2021.e08092. eCollection 2021 Sep.

**PMID:** 34632153

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
