Ongoing Clinical Trials for Procedural Anxiety
Currently, there is one ongoing clinical trial investigating ways to reduce procedural anxiety in children undergoing surgery. The trial is taking place in Belgium and compares the use of a medication called midazolam with a distraction method using tablets or iPads. The goal is to find the safest and most effective approach to help children feel calmer before, during, and after surgical procedures.
Clinical trial locations
Study on Reducing Anxiety in Children Undergoing Surgery: Comparing Midazolam and Tablet Distraction Techniques
This clinical trial focuses on helping children feel less anxious when they need to have surgery. Many children experience stress and nervousness before procedures such as circumcision, dental work, or removal of tonsils and adenoids. This anxiety can make the experience difficult for both the child and their parents.
Who can participate?
Children may be eligible to join this trial if they meet the following conditions:
- They are between 1 and 8 years old
- They are generally healthy or have only mild health issues (classified as ASA 1 or 2)
- They are scheduled for a planned day-care procedure such as circumcision, tonsillectomy, adenoidectomy, or dental care
- Their parents or legal caretakers provide written consent after understanding what the study involves
Who cannot participate?
Children are not eligible if:
- They are younger than 1 year or older than 8 years
- They are not scheduled for one of the specified day-care surgeries
- They have medical conditions that might interfere with the study
- They cannot use or understand a tablet or iPad
- They are allergic to midazolam
- They have a history of severe anxiety or other psychological conditions requiring special treatment
- They are already participating in another clinical trial
- Their parents or guardians do not give permission for participation
What is the trial studying?
The trial compares two different approaches to reducing anxiety in children before surgery. One group of children will use a handheld multimedia device, such as an iPad or tablet, as a distraction tool. The other group will receive a medication called midazolam, given as an oral solution. Midazolam is a type of medicine known as a benzodiazepine that helps calm patients by enhancing the calming effects of a natural brain chemical called GABA.
Researchers will monitor the children at different stages, including before the surgery starts and after they wake up. They will measure anxiety levels using special scales and observe how the children respond during the induction of anesthesia. The study will also track any breathing complications and ask parents about their satisfaction with the anxiety management approach used.
What is the goal?
The main goal is to determine whether using a tablet for distraction can be as effective, or even better, than midazolam in helping children feel less anxious during surgery. By finding the best method, researchers hope to make the surgical experience more comfortable and less stressful for young patients and their families.
Summary
Currently, there is one clinical trial addressing procedural anxiety in children, taking place in Belgium. This trial is particularly focused on children aged 1 to 8 years who are undergoing common day-care surgeries. The study compares a traditional medication approach using midazolam with a non-pharmacological distraction method using tablets or iPads. This reflects growing interest in finding alternatives to medication that may be equally effective while potentially reducing the need for sedatives in young children. The trial aims to provide valuable evidence to help healthcare providers choose the most appropriate anxiety management strategy for pediatric patients.
