Comparing Anxiety Reduction Methods in Children Before Dental Procedures Tell-Show-Do versus Therapeutic Toy

Phase 3

Recruiting

Conditions: Dental caries on pit and fissure surface,

Registration Number: CTRI/2025/04/084134

Lead Sponsor: Dr Anam Shaikh

Brief Summary: **Background:** Dental anxiety in children can lead to uncooperative behavior, making dental procedures challenging. Effective behavior management techniques, such as the **Tell-Show-Do (TSD) method**, help familiarize children with procedures through explanation and demonstration, reducing fear. **Therapeutic toys** offer an alternative approach by providing distraction and emotional comfort. However, there is limited research comparing their effectiveness in managing pre-procedural anxiety.

**Purpose:** This randomized controlled trial aims to evaluate and compare the impact of the **Tell-Show-Do technique** and **therapeutic toys** in reducing anxiety in **6 to 10 year old children** before and after dental restorative procedures. The study seeks to identify the more effective method in improving cooperation and enhancing the overall dental experience.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 66

Inclusion Criteria

Children aged 6 to 10 year old.
Physically and mentally fit children.
Dental caries with a localized enamel breakdown without clinical signs of dentinal involvement requiring restorations without local anaesthesia.
Children whose parents will give written consent for the study.

Exclusion Criteria

Children who might need the administration of local anesthesia while doing the treatment.
Those in need of emergency dental attention (pain, swelling, trauma, etc.) will be excluded from the study.
If the child requires any pharmacological behaviour management technique.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess anxiety of the child before the appointment through a pre-test questionnaire answered by the parent.	1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent. \| 2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent.
2. To assess anxiety of the child at the next appointment through a post-test questionnaire answered by parent.	1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent. \| 2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent.
5. To compare the change in anxiety levels of post-test between Group A (TSD) and Group B (TT).	1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent. \| 2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent.
3. To compare the change in pre-test and post-test anxiety levels of the child.	1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent. \| 2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent.
4. To compare the change in anxiety levels of pre-test between Group A (TSD) and Group B (TT).	1. On the day of the appointment- In the waiting area a pre-test on the anxiety of the child will be given to be answered by the parent. \| 2. Within 7 days of the first appointment- In the waiting area, a post-test on the anxiety of the child will be given to be answered by the parent.

Secondary Outcome Measures

Name	Time	Method
1. To assess knowledge of the child before the appointment through a pre-test questionnaire answered by the parent.	2. To assess knowledge of the parent before the appointment through a pre-test questionnaire.

Trial Locations

Locations (1): Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Anam Shaikh
Principal investigator
7710810858
dranam158@gmail.com