Parental Presence and Preschoolers' Behavior

NCT04580316 | Completed

• 1 other identifier: Parent active/passive presence
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aimed to assess the effect of parental active/passive presence technique (PAP/PPP) on the overall behavior of preschool children with different intelligence and fear levels. Methods: This randomized controlled trial recruited 150 healthy children, 3-6 years old, with no history of previous dental pain/treatment, IQ level ≤70 to ≤110. After sample collection, in the first visit, children were stratified according to their Intelligence Quotient into 3 equal groups (high, average, low) in which each group was further equally and randomly divided into 2 sub-groups (test and control). In the second visit, before intervention with preventive measures, dental fear was assessed using facial image scale. During intervention, the control sub-groups were managed using PPP technique, while the test sub-groups were managed using PAP technique. Overall behavior was assessed using Frankl behavior rating scale at the end of the 2nd visit. Data was analyzed using chi-square test and logistic regression analysis. Results: The PAP technique had significantly higher odds of positive behavior than the PPP technique (P=0.002). Conclusions: Children with low intelligence showed higher dental fear and negative behavior in the dental setting. PAP technique had significant positive effect on the children's overall behavior with different fear and intelligence levels.

Conditions

Parent-Child Relations; Dental Fear

Keywords

Dental fear; Intelligence quotient; Preschool children; Parental technique; Behavior modification

Outcome Measures

Primary Outcomes (2)

• Overall Behavior

  Frankl's Behavior Rating Scale (FBRS) (Frankl, Shiere and Fogels, 1962) At the end of the second visit, after the application of preventive measures, each child overall behavior in each group was evaluated according to Frankl's Behavior Rating Scale (FBRS). It is a four group scale used to assess and evaluate the behavior of a child starting from Rating no. 1 (- -) with the most negative child behavior to Rating no. 4 (++) with the most positive child behavior.

  1 month

• Fear Measure

  Facial Image Scale (FIS) (Buchanan and Niven, 2002) to account for fear state and is entered into the analysis as a confounder. Dental fear was measured in the second visit by administration of Facial Image Scale (FIS). This measurement was done to every child in each group before the start of dental treatment. It is comprised of a row of five faces ranging from very happy face to very unhappy one. Children were asked to point at which face they feel most like at that moment. The face is scored by giving a value of one to the most positive affect face and five to the most negative affect face. The faces with 1 and 2 indicated a low dental fear , while the faces with the value of 4 and 5 indicated high dental fear

  1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

75 children were managed during intervention using Parental Active Presence.

Behavioral: Parental active presence

control group

PLACEBO COMPARATOR

75 children were managed with passive parent presence.

Behavioral: Parent passive presence

Interventions

Parental active presence BEHAVIORAL

The parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions.

Experimental group

Parent passive presence BEHAVIORAL

Parents were instructed to sit silently in the dental clinic behind the patient with no eye contact, and without a spoken word only to reassure their children

control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ranging from 3-6 years (the preoperational stage) (Piaget, 1954; 1966).
• Patients with no history of previous dental treatment and no history of dental pain.
• Patients with at least one sound quadrant for sealant application.
• Patients IQ level should be in the normal intelligence range.

You may not qualify if:

• Multiple dental problems with pain.
• History of previous dental therapy
• History of medical and psychological problems
• Any degree of intellectual disability

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (3)

• Shetty RM, Pashine A, Jose NA, Mantha S. Role of Intelligence Quotient (IQ) on anxiety and behavior in children with hearing and speech impairment. Spec Care Dentist. 2018 Jan;38(1):13-18. doi: 10.1111/scd.12264. Epub 2018 Jan 4.

  PMID: 29314150 BACKGROUND

• Piira T, Sugiura T, Champion GD, Donnelly N, Cole AS. The role of parental presence in the context of children's medical procedures: a systematic review. Child Care Health Dev. 2005 Mar;31(2):233-43. doi: 10.1111/j.1365-2214.2004.00466.x.

  PMID: 15715702 BACKGROUND

• AlDhelai TA, Khalil AM, Elhamouly Y, Dowidar KML. Influence of active versus passive parental presence on the behavior of preschoolers with different intelligence levels in the dental operatory: a randomized controlled clinical trial. BMC Oral Health. 2021 Aug 28;21(1):420. doi: 10.1186/s12903-021-01781-z.

  PMID: 34454468 DERIVED

Study Officials

• Karin M. Dowidar, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only biostatistician was blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 8, 2020
• Study Start: December 20, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 19, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 1 month and for 1 year
• Access Criteria: Request access

Locations

EG (1)