Meditation for Pediatric Anxiety

Overseen By Masuma Anwar, Pharmacy

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Prior surgeries, Anxiety disorders, Developmental delay

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether meditation can reduce anxiety and pain in children undergoing urological surgery. Researchers aim to determine if practicing meditation before, during, and after surgery can lower anxiety and reduce the need for pain medication. The trial includes two groups: one follows a guided meditation regimen, while the other does not. Children aged 6-18, who are undergoing urological surgery and are otherwise healthy, are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the benefits of meditation in a surgical setting.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must record any medications you are taking.

What prior data suggests that meditation is safe for pediatric patients?

Research has shown that meditation is generally safe and easy to handle. Studies have found it can effectively reduce anxiety, stress, and even symptoms of PTSD (post-traumatic stress disorder) without major side effects. In children, meditation has decreased negative feelings like stress and anxiety, leading to long-lasting improvements in mental health. Evidence also indicates that mindfulness practices can help with anxiety and build resilience, especially in schoolchildren. Overall, meditation offers a low-risk way to manage anxiety and improve well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using meditation to help manage pediatric anxiety because it offers a non-drug approach to calming nerves before surgery. Unlike traditional treatments like cognitive-behavioral therapy or medications such as SSRIs, meditation provides a natural way to reduce stress and anxiety. It involves guided sessions that can be easily accessed via email, making it convenient for kids and their parents to practice regularly at home. This approach not only aims to ease anxiety but could also potentially lessen the need for pain medication after surgery.

What evidence suggests that meditation might be an effective treatment for pediatric anxiety?

Research shows that meditation can help reduce anxiety and improve focus in children. Studies have found that kids who meditate often feel less anxious and stressed. In this trial, one group of participants will practice meditation, which previous studies have shown to work as well as other treatments for easing anxiety symptoms. Another study showed that meditation improved overall well-being and resilience to stress. For children, adding meditation to their daily routine has led to a clear drop in anxiety levels. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy kids aged 6-18 at Children's Healthcare of Georgia who are scheduled for urological surgery. They must not have had previous surgeries, anxiety disorders, or developmental delays and should be willing to share their medical history and any past meditation attempts.

Inclusion Criteria

I have documented my medical history and current medications.

I am between 6 and 18 years old.

Otherwise healthy patients

Exclusion Criteria

I have had surgery in the past.

I have a history of anxiety or related disorders.

Diagnosis of developmental delay

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Meditation

Participants engage in a meditation regimen to assess its impact on preoperative anxiety

3 weeks

Daily virtual meditation sessions

Surgery and Immediate Postoperative

Participants undergo urological surgery and are monitored for immediate postoperative pain and anxiety

1 day

In-person surgery and monitoring

Follow-up

Participants are monitored for pain and anxiety levels postoperatively, with a focus on analgesic usage

1 week

1 visit (in-person), daily virtual check-ins

What Are the Treatments Tested in This Trial?

Interventions

• Meditation

Trial Overview

The study aims to see if watching a meditation video can reduce anxiety before, during, and after surgery in children. It also checks if regular meditation leads to less pain post-surgery by tracking how often they need painkillers.

How Is the Trial Designed?

Group I: 30 study subjects with meditation Experimental Treatment 2 Interventions

The meditation regimen will be linked in a Qualtrics that is delivered to them via email daily. The patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen. The first PeSSKi (Perceived Stress Scale for Kids) questionnaire survey will be asked and sent via email after the appointment surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see impact of meditation and anxiety levels at this point. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess the pain label of the patient is still in after the quantity of analgesic usage logged throughout the week.

Group II: 30 study subjects without meditation Placebo Group 1 Intervention

The control group will only receive the questionnaire without meditation. The first PeSSKi questionnaire survey will be asked and sent via email after the appointment where the surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see the anxiety levels are at this point. The third questionnaire survey will be done immediately before the day of the surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". The questionnaire link is given bellow: https://augusta.qualtrics.com/jfe/form/SV\_2b2DZ9x16jY9IzQ (PeSSKi questionnaire) The control group will receive just the PeSSKi questionnaire.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

The adapted FRIENDS program for anxiety showed similar effectiveness to the CATS program in reducing anxiety symptoms among students, with small changes reported by both child and parent assessments, indicating that both interventions can be beneficial in school settings.

CATS was found to be significantly more cost-effective than FRIENDS, and therapists reported that FRIENDS required more adaptations to fit the urban school context, suggesting that cultural fit is crucial for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two group cognitive behavioral therapy protocols for anxiety in urban schools: appropriateness, child outcomes, and cost-effectiveness. Lawson, GM., Jawad, AF., Comly, R., et al.[2023]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

Citations

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Meditation for Pediatric Anxiety · Info for Participants

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