Using a lollipop to reduce preoperative anxiety in children
Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
NA · Tunis University · NCT06670846
This study is testing whether giving a lollipop can help reduce anxiety in children before surgery compared to a medication given through the nose.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Tunis University (other) |
| Locations | 1 site (Tunis, Tunis Governorate) |
| Trial ID | NCT06670846 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using a lollipop as a distraction method compared to administering intranasal midazolam to manage preoperative anxiety in children. Participants are randomly assigned to receive either the lollipop or midazolam 15 minutes before entering the operating room. The study assesses anxiety levels using the modified Yale Preoperative Anxiety Scale and evaluates sedation, parent separation quality, and acceptance of anesthesia induction. The goal is to determine which method is more effective in alleviating anxiety in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children over 4 years old classified as ASA physical status 1 or 2.
Not a fit: Children who refuse premedication or have perioperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and child-friendly method to reduce anxiety in children undergoing surgery.
How similar studies have performed: While distraction techniques have been explored in pediatric settings, the specific use of a lollipop as a distraction method in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 4 ans , ASA 1 ou 2 Exclusion Criteria: * Children who rejected premedication - The occurrence of perioperative complications
Where this trial is running
Tunis, Tunis Governorate
- Bechir Hamza hospital — Tunis, Tunis Governorate, Tunisia (RECRUITING)
Study contacts
- Study coordinator: salma Aouadi, consultant
- Email: salmaaouadi1@gmail.com
- Phone: 0021656652210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety, Preoperative, anxiety, children, anesthesia, distraction, midazolam