Mystic Pets for Anxiety

Overseen By Man Yee Suen, MMedSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Hearing impairment, Neurological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Mystic Pets safe for humans?

Complementary and alternative medicine (CAM) products, like Mystic Pets, are generally considered low risk, but they can still cause adverse reactions. While most CAM products don't present a high risk, it's important to be aware of potential interactions with other medications and to consider the overall safety profile. ^{1 2 3 4 5}

How does the Mystic Pets treatment for anxiety differ from other treatments?

Mystic Pets for Anxiety is unique because it likely involves a novel approach or combination of ingredients not typically used in standard anxiety treatments, such as plant-based or herbal components. Unlike traditional medications, which often target specific brain chemicals, this treatment may offer a more holistic or alternative method, potentially with fewer side effects. ^{6 7 8 9 10}

What is the purpose of this trial?

This mixed-methods study seeks to evaluate the feasibility of Mystic Pets software and hardware within the pediatric population. This study will take place at Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA).

Eligibility Criteria

This trial is for children experiencing anxiety who are patients at Lucile Packard Children's Hospital. Specific eligibility criteria have not been provided, so it's best to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I am between 4 and 18 years old.

Exclusion Criteria

Legal guardian not present to obtain consent

Child with facial abnormalities or injuries prohibiting use of headsets

My child has a hearing problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants use the Mystic Pets software and hardware to evaluate its feasibility and usability

1 day

1 visit (in-person)

Follow-up

Participants provide qualitative feedback and complete various usability and engagement scales

immediately after intervention

Treatment Details

Interventions

• Mystic Pets

Trial Overview The trial is testing 'Mystic Pets', a software and hardware solution designed to help with anxiety in pediatric patients. The study will assess how practical and useful this technology is in a hospital setting.

Participant Groups

Group I: Mystics Pets group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

A review of 64,493 adverse reaction reports to the Swedish Medical Products Agency from 1987 to 2006 identified 778 reports related to complementary and alternative medicine (CAM) products, highlighting that these products can cause significant adverse reactions, including serious ones like pulmonary embolism and anaphylaxis.

The most commonly reported CAM substances associated with adverse reactions included Echinacea purpurea and Ginkgo biloba, indicating that while CAM products are popular, they carry risks that warrant further investigation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. Jacobsson, I., Jönsson, AK., Gerdén, B., et al.[2009]

Many consumers mistakenly believe that complementary and alternative medicine (CAM) products are inherently safe, which raises concerns about potential interactions with pharmaceutical drugs, especially as their simultaneous use increases among Australians.

While adverse reactions to CAM products are generally low, there is a need for more systematic research to accurately define the risks associated with CAM, as current evidence suggests that most products do not pose a high risk but require further investigation to understand their impact on public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. Myers, SP., Cheras, PA.[2004]

A study analyzing 489 kratom-related adverse drug reactions (ADRs) reported to the FDA from 2004 to 2021 found that kratom use is associated with significant safety concerns, including a 63-fold higher than expected rate of accidental deaths.

The analysis revealed strong signals for addiction and withdrawal symptoms, as well as a notable number of reports related to toxicity and seizures, indicating that while kratom is popular for treating pain and anxiety, it poses potential health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021. Li, X., Ndungu, P., Taneja, SB., et al.[2023]

The study developed a flowchart to classify adverse events (AEs) reported for veterinary products, analyzing 531 reports and identifying 20 types of AEs and 88 product-AE combinations.

Using three different signal detection models, the research found seven significant signals across all methods, demonstrating that combining multiple detection techniques improves the effectiveness of pharmacovigilance in monitoring veterinary product safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event classification and signal detection of data from the customer service and pharmacovigilance of a multinational veterinary pharmaceutical company. Marcon, DS., Queiroz, MR., Baquero, OS.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. [2009]

2. Australia pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. [2004]

3. England pubmed.ncbi.nlm.nih.gov

Adverse effects of herbal medicines: an overview of systematic reviews. [2022]

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

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse event classification and signal detection of data from the customer service and pharmacovigilance of a multinational veterinary pharmaceutical company. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Plant-based medicines for anxiety disorders, part 2: a review of clinical studies with supporting preclinical evidence. [2022]

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

Efficacy and safety of the Chinese herbal medicine Xiao Yao San for treating anxiety: a systematic review with meta-analysis and trial sequential analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

GABA and 5-HT Systems Are Involved in the Anxiolytic Effect of Gan-Mai-Da-Zao Decoction. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Plant-based medicines for anxiety disorders, Part 1: a review of preclinical studies. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Herbal remedies for anxiety - a systematic review of controlled clinical trials. [2018]