The impact of mothers' education on modifying the child's behavior during dental care
| ISRCTN | ISRCTN17901482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17901482 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 4863 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 25/09/2024
- Registration date
- 30/09/2024
- Last edited
- 30/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental fear and anxiety are significant challenges in pediatric dentistry. Effective behavior management is crucial when assessing the impact of dental anxiety, which may limit dental care either completely or partially. Parents, particularly mothers, play an important role in shaping their child's responses in the dental clinic, especially when negative dental experiences are involved. This study aims to evaluate how maternal awareness and education can change children's behavior.
Who can participate?
Children and their mothers aged 6 to 12 years attending the Department of Pediatric Dentistry at Damascus University
What does the study involve?
Mothers receive a brochure that provides information about their relationship with their child, their role in providing dental care, and strategies for establishing positive behavior in their children. The brochure also outlines desirable maternal behavior before and during treatment, as well as the preferred behaviors and appropriate language to use and avoid.
What are the possible benefits and risks of participating?
This study may contribute to changing the behavior of uncooperative children and enhancing their positive behavior, obtaining the required dental care and improving their oral health.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2023 to March 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Mariam Sharaf, mariam96.sharaf@damascusuniversity.edu.sy, mariamsh576@gmail.com
Contact information
Public, Scientific, Principal investigator
Al-Mazzeh Street
Damascus
0000
Syria
| Phone | +963 (0)993090861 |
|---|---|
| mariam96.sharaf@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The influence of maternal awareness and education on behavior modification in school-aged uncooperative children during dental care (interventional study) |
| Study objectives | Educating mothers using brochures in order prepare children before receiving dental treatment improve the children's behavior during treatment. |
| Ethics approval(s) |
Approved 24/07/2023, Damascus University (Al-Mazzeh Street, Damascus, 0000, Syria; +963 (0)1133923000; dl.srd@damascusuniversity.edu.sy), ref: 4863 |
| Health condition(s) or problem(s) studied | Modifying the behavior of uncooperative children during dental care |
| Intervention | This interventional study involves 60 child–mother pairs who attended the Department of Pediatric Dentistry at Damascus University. The children aged 6 to 12 years exhibit negative or definitely negative behavior according to the Frankl behavior rating scale and require sealant placement on one of their permanent first molars. Mothers will receive a brochure that provides information about their relationship with their child, their role in providing dental care, and strategies for establishing positive behavior in their children. The brochure also outlined desirable maternal behavior before and during treatment, as well as the preferred behaviors and appropriate language to use and avoid. One week later, the sealant is applied to one of the permanent first molars. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Behavior assessed using the Frankl Behavior Scale at the first visit and the treatment visit |
| Key secondary outcome measure(s) |
Dental anxiety in mothers measured using the Modified Dental Anxiety Scale (MDAS) at the first visit |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 65 |
| Key inclusion criteria | 1. Children aged 6 to 12 years who displayed negative or definitely negative behavior according to the Frankl behavior rating scale 2. Visiting the pediatric dentistry department for the first time |
| Key exclusion criteria | 1. Children with general health problems or limited communication abilities 2. Children with previous dental experiences, or suffering from acute tooth pain 3. Children whose mothers declined to participate in the study |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Al-Mazzeh Street
Damascus
0000
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Mariam Sharaf (mariam96.sharaf@damascusuniversity.edu.sy, mariamsh576@gmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/09/2024: Study's existence confirmed by Damascus University.
