Nail BitingNCT06471153
Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.
A study testing Empowerment Program Based on BASNEF Model and Routine Health Education in people with Nail Biting, run by Alexandria University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Nail Biting
- What is being tested?
- Empowerment Program Based on BASNEF Model and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2023to 20 Dec 2023
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Had nail-biting habits
- Willing to attend the educational sessions
Who cannot join
- Had history of mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nail Biting
- Being tested
- Empowerment Program Based on BASNEF Model, Routine Health Education
- Keywords
- BASNEF Model, Children, Knowledge, Nail Biting, Practice, Self-efficacy
- Medical subject headings
- Nail Biting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Program Based on BASNEF ModelBehavioural
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.
Routine Health EducationBehavioural
Children in the control group received routine health education about the problems of nail-biting and routine advice to quit nail-biting.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Received the empowerment program based on the BASNEF model Receives: Behavioral: Empowerment Program Based on BASNEF Model |
| Control Group | Active comparator | received the routine care Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Nail-Biting Knowledge
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.
Measured: one month
Children's Nail-Biting Practice/Habits
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).
Measured: one month
Children's Attitude and Self-efficacy Towards Nail-biting
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.
Measured: one month
Subjective Norms and Enabling Factors of Nail-Biting Among Children
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Apr 2023
- Primary completion18 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nail BitingStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Zohour I Rashwan, Professor, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471153
- Sponsor's protocol ID
- 7/2022PEDI2-1
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30360596Abd-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.
PubMed 36801961Gur 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.
PubMed 29797491Ghanizadeh 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.
PubMed 21481256Ergun 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.
PubMed 23492878Silva 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.
PubMed 31232226Baghchechi 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.
PubMed 32964094Rashwan ZI, Darweesh HAM, Elsobky FA, Amer SAM, Nada MAA. BASNEF behavioral transformation: effect of empowerment program on children's knowledge, attitude, self-efficacy, and practice of nail biting. BMC Pediatr. 2025 Apr 22;25(1):312. doi: 10.1186/s12887-025-05450-w.
PubMed 40264049
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASNEF Behavioral Transformation: Effect of Empowerment Program on Children's Knowledge, Attitude, Self-Efficacy, and Practice of Nail Biting.
- ClinicalTrials.gov ID
- NCT06471153
- Acronym / sponsor ID
- 7/2022PEDI2-1
- Conditions
- Nail Biting
- Keywords
- BASNEF Model, Children, Knowledge, Nail Biting, Practice, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 24 Jun 2024 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Empowerment Program Based on BASNEF ModelReceived the empowerment program based on the BASNEF model |
| Control Group | Active comparator | Behavioral: Routine Health Educationreceived the routine care |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Had nail-biting habits
- Willing to attend the educational sessions
Key exclusion criteria (1 listed)
- Had history of mental illness
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 |
|---|---|---|
| Empowerment Program Based on BASNEF ModelInitially, 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. | Behavioural | Study Group |
| Routine Health EducationChildren in the control group received routine health education about the problems of nail-biting and routine advice to quit nail-biting. | Behavioural | Control Group |
Primary outcome
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.
Children's Nail-Biting Practice/Habits
Time frame: one month
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).
Children's Attitude and Self-efficacy Towards Nail-biting
Time frame: one month
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.
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
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 24 Jun 2024.
- Background: PubMed 30360596Zareipour 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.
- Background: PubMed 36801961Abd-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.
- Background: PubMed 29797491Gur 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.
- Background: PubMed 21481256Ghanizadeh 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.
- Background: PubMed 23492878Ergun 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.
- Background: PubMed 31232226Silva 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.
- Background: PubMed 32964094Baghchechi 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.
- Derived from this study: PubMed 40264049Rashwan ZI, Darweesh HAM, Elsobky FA, Amer SAM, Nada MAA. BASNEF behavioral transformation: effect of empowerment program on children's knowledge, attitude, self-efficacy, and practice of nail biting. BMC Pediatr. 2025 Apr 22;25(1):312. doi: 10.1186/s12887-025-05450-w.
- Individual participant dataSharing planned: No
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Nail Biting
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.
Zohour I Rashwan, Professor 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 Empowerment Program Based on BASNEF Model and Routine Health Education in people with Nail Biting, 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 2 inclusion and 1 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 24 Jun 2024. 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. 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?
Children's Nail-Biting Knowledge (time frame: one month). The study lists 4 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 NCT06471153, which also lists 8 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 24 Jun 2024.