- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06471153
Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.
BASNEF Behavioral Transformation: Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.
The study aims to evaluate the effect of an empowerment program based on the BASNEF model on children's knowledge, attitude, self-efficacy, and practice of nail biting.
Research Hypothesis H1: The application of an empowerment program based on the BASNEF model has a positive impact on children's knowledge, attitude, self-efficacy, and practice of nail biting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nail-biting or onychophagia is a common phenomenon affecting children where excessive nail-biting is associated with several adverse consequences beyond mere appearance. The aim is to evaluate the effect of an empowerment program based on the BASNEF model on children's knowledge, attitude, self-efficacy, and practice of nail biting.
A quasi-experimental study was conducted in the pediatric wards of Menoufia University Hospital and Benha University Hospital. A convenience sample of 135 children aged 6 to 18 was randomly assigned to two groups. The study group attended four empowerment sessions based on the BANSEF model, emphasizing age-appropriate information, fostering a positive attitude towards quitting nail-biting, discovering the subjective norms that influence nail-biting behaviors, and equipping children with enabling factors to quit. The control group received routine health education.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt, 32511
- Alexandria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Had nail-biting habits
- Willing to attend the educational sessions
Exclusion Criteria:
- Had history of mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Group
Received the empowerment program based on the BASNEF model
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Initially, the researcher established rapport with children of both groups and their gradians, screened them for the eligibility criteria, explained the aim of the study, the duration and nature of the training sessions, and obtained informed assent.
The researcher established the session objectives and learning activities and prepared the learning materials.
The researchers also prepared the learning environment.
The Empowerment program is implemented in accordance with the BANCEF model for behavior transformation into four educational sessions.
After the intervention, children's nail-biting knowledge, practice, attitude, and self-efficacy were reassessed.
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Active Comparator: Control Group
received the routine care
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Children in the control group received routine health education about the problems of nail-biting and routine advice to quit nail-biting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Children's Nail-Biting Knowledge
Time Frame: one month
|
It includes ten questions about nail biting revolving around the definition (2 items), predisposing factors (2 items), complications and adverse effects (3 items), and management (3 items).
A score of (1) was given for the correct answer and zero for the incorrect one.
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one month
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Children's Nail-Biting Practice/Habits
Time Frame: one month
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It includes ten items describing the children's nail-biting habit, including frequency and duration (2 items), aggravating factors (2 items), areas involved in nail-biting (3 items), and description of nail-biting behavior (3 items).
They are instructed to self-monitor their nail-biting behaviors on five a 5-point Likert scale ranging from very frequent (4) to never (0).
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one month
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Children's Attitude and Self-efficacy Towards Nail-biting
Time Frame: one month
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It consists of 13 items; 10 items measure the child's attitude, and three items assess their intention to act (self-efficacy).
Children were asked to rate their answers on a 5-point Likert scale ranging from Strongly Agree (4) to (0) Strongly Disagree.
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one month
|
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Subjective Norms and Enabling Factors of Nail-Biting Among Children
Time Frame: one month
|
The questionnaire includes ten yes/No questions divided into two categories.
The subjective norms category consists of 8 items describing the external factors that influence children either to increase or quit their nails
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one month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zohour I Rashwan, Professor, Alexandria University
Publications and helpful links
General Publications
- Zareipour MA, Mahmoodi H, Valizadeh R, Ghelichi Ghojogh M, Rezaie Moradali M, Zare F. Impact of an Educational Intervention Based on the BASNEF Model on Skin Cancer Preventive Behavior of College Students. Asian Pac J Cancer Prev. 2018 Oct 26;19(10):2717-2722. doi: 10.22034/APJCP.2018.19.10.2717.
- Abd-Elsabour MAA, Hanafy RMH, Omar OM. Association between children's resilience and practising oral habits: a cross-sectional study. Br Dent J. 2023 Feb 17:1-5. doi: 10.1038/s41415-023-5565-7. Online ahead of print.
- Gur K, Erol S, Incir N. The effectiveness of a nail-biting prevention program among primary school students. J Spec Pediatr Nurs. 2018 Jul;23(3):e12219. doi: 10.1111/jspn.12219. Epub 2018 May 24.
- Ghanizadeh A, Shekoohi H. Prevalence of nail biting and its association with mental health in a community sample of children. BMC Res Notes. 2011 Apr 11;4:116. doi: 10.1186/1756-0500-4-116.
- Ergun A, Toprak R, Sisman FN. Impact of a healthy nails program on nail-biting in Turkish schoolchildren: a controlled pretest-posttest study. J Sch Nurs. 2013 Dec;29(6):416-24. doi: 10.1177/1059840513481386. Epub 2013 Mar 14.
- Silva LCD, Vedovello SAS, Vedovello Filho M, Meneghin MC, Ambrosano Bovi GM, Degan VV. Anxiety and oral habits as factors associated with malocclusion. Cranio. 2021 May;39(3):249-253. doi: 10.1080/08869634.2019.1633492. Epub 2019 Jun 23.
- Baghchechi M, Pelletier JL, Jacob SE. Art of Prevention: The importance of tackling the nail biting habit. Int J Womens Dermatol. 2020 Sep 17;7(3):309-313. doi: 10.1016/j.ijwd.2020.09.008. eCollection 2021 Jun.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7/2022PEDI2-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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