Covid 19 Research using Clinical Trials (Home Page)
Report for D020920: Dyssomnias NIH
(Synonyms: Dyssomnias)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1 | "Calm" is a mindfulness meditation mobile app Wiki | 0.58 |
| drug237 | Calm Meditation App Wiki | 0.58 |
| drug927 | Questionnaires Wiki | 0.58 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020447 | Parasomnias NIH | 1.00 |
| D012893 | Sleep Wake Disorders NIH | 1.00 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. Many obstetrics and gynecology patients are additionally experiencing increased stress due to the healthcare changes the COVID-19 pandemic has caused including delayed or canceled elective surgeries, visitor restrictions, and telemedicine visits instead of in person clinic visits. Mindfulness meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Mindfulness meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective randomized controlled trial evaluating perceived stress, anxiety, and sleep disturbance in the investigators outpatient OB/Gyn patients at Banner Women's Institute, with the use of a 30 day trial of the mindfulness meditation app, "Calm." All patients would ultimately receive a 30 day free trial of the mobile meditation app, however the intervention group would receive the 30-day free trial immediately and the control group would receive the 30-day free trial after the study period which is 30 days after enrollment. The investigators additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and patient satisfaction with use of the app.
NCT04329533 Perceived Stress Anxiety Sleep Disturbance Other: "Calm" is a mindfulness meditation mobile app MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 0Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 14Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 30Secondary Outcomes
Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Measure: Hospital Anxiety and Depression Scale Time: Completed study Day 0 and study Day 30Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Measure: PROMIS Sleep Disturbance Short Form Survey Time: Completed study Day 0 and study Day 30Description: Usage data from mobile app, minutes per day used, days per week used
Measure: Adherence Time: From Day 0 to Day 30Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length and measured with 5-point Likert scale.
Measure: Participant Satisfaction Time: Completed study Day 30Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale.
Measure: Coronavirus Questionnaire Time: Completed study Day 0 and study Day 302 Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry
The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.
NCT04370210 Sleep Disturbance Behavioral: Questionnaires MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.
Measure: Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up Time: An average of 1 daySecondary Outcomes
Description: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe).
Measure: Assessment of child depression in both groups Time: An average of 1 dayDescription: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The total score is interpreted using the correspondence tables in function of sex and age
Measure: Assessment of child anxiety in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of socio-demographic factors (age, sex, lifestyle, couple status, profession and socio-professional category, education)
Measure: Assessment of the influence of socio-demographic factors on sleep in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). For their parents, sleep quality and anxiety level are measured with a numerical scale between 0 and 10. For sleep quality, 0 correspond to a very poor quality and 10 to a very good quality. For anxiety level, 0 correspond to no anxiety and 10 to a severe anxiety. The score obtained for child is interpreted in function of their parents score.
Measure: Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups Time: An average of 1 dayDescription: Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 dayDescription: Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 dayDescription: Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measure: Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry Time: An average of 1 day3 Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
NCT04374786 Perceived Stress Anxiety Sleep Disturbance Burnout PTSD Device: Calm Meditation App MeSH:Dyssomnias Sleep Wake Disorders Parasomnias
Primary Outcomes
Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 0Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 14Description: Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measure: Perceived Stress Scale Time: Completed study Day 30Secondary Outcomes
Description: Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Measure: Hospital Anxiety and Depression Scale Time: Completed study Day 0, 14, and study Day 30Description: Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Measure: PROMIS Sleep Disturbance Short Form Survey Time: Completed study Day 0, 14, and study Day 30Description: The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.
Measure: Impact of Event Scale-6 Time: Completed study Day 0, 14, and study Day 30Description: The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.
Measure: Maslach Burnout Inventory Time: Completed study Day 0, 14, and study Day 30Description: Usage data from mobile app, minutes per day used
Measure: Adherence Time: From Day 0 to Day 30Description: Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.
Measure: Coronavirus Questionnaire Time: Completed study Day 0 and study Day 30Description: Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.
Measure: Participant Satisfaction Time: Completed study Day 30