The study will be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood/stress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Participants will be asked to take questionnaires to collect baseline at the beginning of the study. The questionnaires are: Perceived Stress Scale for children (PSS-ch), The Positive Affect and Negative Affect Schedule-Child Form-children (PANAS-children) and the Children's Sleep Habits Questionnaire (CSHQ). The interventional treatment will be for a total of 4 weeks (28 days). Participants will be asked to take the questionnaires at the end of the 28 days. The subjects will attend two appointments in the clinic throughout the duration of the study.
For these scale, here are some more details: The PSS-C: Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56. Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome. The PANAS-C: Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in: * Positive Affect (PA): 15 to 75 * Negative Affect (NA): 15 to 75 Interpretation: Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome) The CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99. Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
Placebo
Dietary Supplement containing magnesium, L-theanine and lemon balm extract
TKL Research
Fair Lawn, New Jersey, United States
To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.
PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on the scales The PSS-C: (perceived stress scale -children form) Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56. Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
Time frame: from enrollment to end of study at Week 4
To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.
PANAS-children questionnaire will be administered before the intervention, to establish baseline, 40 min after initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement of positive and negative mood across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on scale: The PANAS-C: (positive and negative affect scale-children form) Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in: * Positive Affect (PA): 15 to 75 * Negative Affect (NA): 15 to 75 Interpretation: Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)
Time frame: from enrollment to end of study at Week 4
To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.
CSHQ questionnaire will be administered before the intervention, to establish baseline, and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement sleep quality across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on scale: The CSHQ (children sleep habits questionnaire) Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99. Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
Time frame: from enrollment to end of study at Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.