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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Meditation for Pediatric Anxiety?

Research shows that meditation can help reduce anxiety and improve attention in children, as seen in studies where mindfulness training led to decreased anxiety symptoms and better attention scores. Additionally, meditation has been used successfully to lower emotional distress in both adults and children, suggesting it may be beneficial for pediatric anxiety. ^{1 2 3 4 5}

Is meditation safe for children?

Meditation is generally considered safe for children, but some studies have reported potential side effects, mostly related to mental health. However, many studies do not report on adverse events, making it hard to fully assess the risks. ^{3 6 7 8 9}

How is meditation different from other treatments for pediatric anxiety?

Meditation for pediatric anxiety is unique because it focuses on calming the mind through mindfulness and breathing exercises, rather than using medication or traditional therapy like cognitive behavioral therapy (CBT). This approach can be more accessible and less invasive, making it a suitable option for children who may not have access to mental health services or prefer non-drug interventions. ^{10 11 12 13 14}

What is the purpose of this trial?

1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery. 2. The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Meditation reduces brain activity in the default mode network in children with active cancer and survivors. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of mindfulness training on resting-state networks in pre-adolescent children with sub-clinical anxiety related attention impairments. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

School-Based Meditation and Interoceptive Awareness Program for Preventing Somatic Symptoms: The Role of Emotional Awareness. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Meditation and mindfulness in clinical practice. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Meditation for the management of adjustment disorder anxiety and depression. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events of Mind-Body Interventions in Children: A Systematic Review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the reporting of adverse events associated with medical herb use among children. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The impact of a guided paced breathing audiovisual intervention on anxiety symptoms in Palestinian children: a pilot randomized controlled trial. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Anxiety States in childhood. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

The pharmacological management of childhood anxiety disorders: a review. [2022]

13. Switzerland 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. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Complementary and Integrative Medicine for Anxiety in Children, Adolescents, and Young Adults. [2023]