Parent-Child RelationsNCT04580316
Parental Presence and Preschoolers' Behavior
A study testing Parental active presence and Parent passive presence in people with Parent-Child Relations and Dental Fear, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Parent-Child Relations, Dental Fear
- What is being tested?
- Parental active presence and Parent passive presence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2017to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Multiple dental problems with pain.
- History of previous dental therapy
- History of medical and psychological problems
- Any degree of intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
The design of the study was a randomized controlled clinical trial with an allocation ratio of 1:1. Children enrolled in this study were stratified based on their IQ into three groups; high, average and low IQ groups. In each of these three groups, children were randomly and equally allocated into study and control subgroups. Thus, this study included 6 subgroups.
- Visual Screening and History taking were carried out to identify children who fulfilled the inclusion criteria. Parental meeting was also conducted to explain the child entire research plan.
The children were recruited from the Outpatient clinic of Pediatric Dentistry Department in Faculty of Dentistry at Alexandria University.
The IQ test for each selected child took place in a quiet closed room (special need clinic). The preventive measures were applied in the pediatric clinic of the department.
- Interventions
In the first visit, children who fulfilled the inclusion/ exclusion criteria were evaluated by IQ test then divided into 3 equal groups (50 children) according to their level of intelligence IQ as follows:
- High IQ Children group (HIQ): with score of (110 and above)
- Average IQ Children (AIQ): with score of (90-109)
- Low IQ Children (LIQ)(with the normal intelligence range): with score of (70-89) In the second visit, fear was measured in each group followed by random allocation into test and control subgroups and then the implementation of the intervention.
- In each group (50 children), 25 children in subgroup S (study group) were managed using Parental Active Presence (PAP) technique, while the other 25 children in subgroup C (control group) were managed using Parental Passive Presence (PPP) technique. Parental Active / Passive Presence technique was accompanied with Tell-Show-Do (TSD) Technique (Addelston, 1959). During this management, dental preventive measures were applied.
- Conditions
- Parent-Child Relations, Dental Fear
- Being tested
- Parental active presence, Parent passive presence
- Keywords
- Dental fear, Intelligence quotient, Preschool children, Parental technique, Behavior modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental active presenceBehavioural
The parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions.
Parent passive presenceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 75 children were managed during intervention using Parental Active Presence. Receives: Behavioral: Parental active presence |
| control group | Placebo comparator | 75 children were managed with passive parent presence. Receives: Behavioral: Parent passive presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start20 Dec 2017
- Primary completion1 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Youssef Attia, Alexandria University
- Investigators
- Karin M. Dowidar, PhD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580316
- Sponsor's protocol ID
- Parent active/passive presence
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the study protocol
Publications
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.
PubMed 29314150Piira 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.
PubMed 15715702AlDhelai 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.
PubMed 34454468
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04580316
- Acronym / sponsor ID
- Parent active/passive presence
- Conditions
- Parent-Child Relations, Dental Fear
- Keywords
- Dental fear, Intelligence quotient, Preschool children, Parental technique, Behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The design of the study was a randomized controlled clinical trial with an allocation ratio of 1:1. Children enrolled in this study were stratified based on their IQ into three groups; high, average and low IQ groups. In each of these three groups, children were randomly and equally allocated into study and control subgroups. Thus, this study included 6 subgroups.
- Visual Screening and History taking were carried out to identify children who fulfilled the inclusion criteria. Parental meeting was also conducted to explain the child entire research plan.
The children were recruited from the Outpatient clinic of Pediatric Dentistry Department in Faculty of Dentistry at Alexandria University.
The IQ test for each selected child took place in a quiet closed room (special need clinic). The preventive measures were applied in the pediatric clinic of the department.
- Interventions
In the first visit, children who fulfilled the inclusion/ exclusion criteria were evaluated by IQ test then divided into 3 equal groups (50 children) according to their level of intelligence IQ as follows:
- High IQ Children group (HIQ): with score of (110 and above)
- Average IQ Children (AIQ): with score of (90-109)
- Low IQ Children (LIQ)(with the normal intelligence range): with score of (70-89) In the second visit, fear was measured in each group followed by random allocation into test and control subgroups and then the implementation of the intervention.
- In each group (50 children), 25 children in subgroup S (study group) were managed using Parental Active Presence (PAP) technique, while the other 25 children in subgroup C (control group) were managed using Parental Passive Presence (PPP) technique. Parental Active / Passive Presence technique was accompanied with Tell-Show-Do (TSD) Technique (Addelston, 1959). During this management, dental preventive measures were applied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Parental active presence75 children were managed during intervention using Parental Active Presence. |
| control group | Placebo comparator | Behavioral: Parent passive presence75 children were managed with passive parent presence. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Multiple dental problems with pain.
- History of previous dental therapy
- History of medical and psychological problems
- Any degree of intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental active presenceThe parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions. | Behavioural | Experimental group |
| Parent passive presenceParents 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 | Behavioural | control group |
Primary outcome
Overall Behavior
Time frame: 1 month
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.
Fear Measure
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 29314150Shetty 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.
- Background: PubMed 15715702Piira 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.
- Derived from this study: PubMed 34454468AlDhelai 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.
- Individual participant dataSharing planned: Yes. We will share the study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin M. Dowidar, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental active presence and Parent passive presence in people with Parent-Child Relations and Dental Fear, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Behavior (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580316, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.