NCT06471153

Brief 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, self-efficacy, and practice of nail biting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 18, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

BASNEF ModelChildrenKnowledgeNail BitingPracticeSelf-efficacy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    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.

    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

    one month

Study Arms (2)

Study Group

EXPERIMENTAL

Received the empowerment program based on the BASNEF model

Behavioral: Empowerment Program Based on BASNEF Model

Control Group

ACTIVE COMPARATOR

received the routine care

Behavioral: Routine Health Education

Interventions

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.

Study Group

Children in the control group received routine health education about the problems of nail-biting and routine advice to quit nail-biting.

Control Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Had nail-biting habits
  • Willing to attend the educational sessions

You may not qualify if:

  • Had history of mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 32511, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 30360596BACKGROUND
  • 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.

    PMID: 36801961BACKGROUND
  • 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.

    PMID: 29797491BACKGROUND
  • 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.

    PMID: 21481256BACKGROUND
  • 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.

    PMID: 23492878BACKGROUND
  • 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.

    PMID: 31232226BACKGROUND
  • 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.

    PMID: 32964094BACKGROUND
  • Rashwan 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.

MeSH Terms

Conditions

Nail Biting

Condition Hierarchy (Ancestors)

HabitsBehavior

Study Officials

  • Zohour I Rashwan, Professor

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Profesor

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

April 20, 2023

Primary Completion

December 18, 2023

Study Completion

December 20, 2023

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations