Evaluating Operation Calm With Children, Parents, and Clinicians

Children and adolescents aged 6-17 years will complete one guided Operation Calm session using a smartphone-compatible virtual reality headset. The session combines an immersive 360° nature environment with guided mindfulness exercises involving paced breathing, sensory awareness, grounding, and present-moment attention. Each child will view one of five nature scenes. Parents and clinicians will view the intervention through a secure online link without using a VR headset and will provide feedback on its acceptability, appropriateness, usefulness, and feasibility.

Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for children and adolescents aged 6-17 years. Children complete one brief immersive 360° nature experience paired with guided mindfulness exercises focused on paced breathing, grounding, sensory awareness, present-moment attention, and reflection on calm and safety. Each child is assigned one of five nature scenes and views the intervention using a smartphone-compatible VR headset. The intervention is designed to teach coping skills that may eventually support children facing medical or dental procedures. Parents and clinicians view the intervention through a secure online link and provide feedback. This is a single-arm feasibility study and does not include a control condition.

Pediatric Simulator Sickness Questionnaire (Peds SSQ): A self-report questionnaire assessing simulator sickness symptoms following virtual reality exposure. Total scores range from 0 to 90, with higher scores indicating greater simulator sickness (worse tolerability).

Percentage of individuals who enroll in the study among all individuals approached or responding to recruitment materials. Calculated as: number enrolled ÷ number approached or responding × 100.

Unit of Measure: Percentage of individuals

Percentage of screened individuals who meet the study eligibility criteria. Calculated as: number eligible ÷ number screened × 100.

Percentage of eligible individuals who provide informed consent or parental consent and child assent, as applicable. Calculated as: number consenting ÷ number eligible × 100.

Percentage of enrolled participants who complete the assigned Operation Calm session. Calculated as: number completing the intervention ÷ number enrolled × 100.

Percentage of intervention sessions during which at least one technical difficulty occurs, including difficulties involving the virtual reality headset, smartphone, video playback, audio, internet connection, or study link. Calculated as: sessions with at least one technical difficulty ÷ total sessions initiated × 100.

Total number of technical difficulties recorded during intervention delivery. Multiple technical difficulties may be recorded during a single session.

Percentage of participants who begin but discontinue the Operation Calm session before completing it. Calculated as: number discontinuing early ÷ number beginning the intervention × 100.

Child-rated acceptability will be assessed using the quantitative items of the Operation Calm Child Evaluation Questionnaire. The questionnaire assesses comprehension, engagement, usability, appropriateness, perceived usefulness, and satisfaction. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.

Parent-rated acceptability will be assessed using the quantitative items of the Operation Calm Parent Evaluation Questionnaire. The questionnaire assesses comprehension, appropriateness, perceived usefulness, satisfaction, and perceptions of the intervention's suitability for children and adolescents. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.

Clinician-rated acceptability will be assessed using the quantitative items of the Operation Calm Clinician Evaluation Questionnaire. The questionnaire assesses appropriateness, usability, perceived usefulness, satisfaction, and perceived suitability for use before medical or dental procedures. An overall acceptability score will be calculated as the mean of the applicable items. Higher scores indicate greater acceptability.

Children will rate their current anxiety using a visual scale ranging from 0 to 10, where 0 means "not anxious at all" and 10 means "extremely anxious." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change. This outcome is exploratory and will not be interpreted as evidence of clinical effectiveness.

Children will rate their current calmness using a visual scale ranging from 0 to 10, where 0 means "not calm at all" and 10 means "completely calm." Ratings will be completed immediately before and after Operation Calm and compared to explore immediate change.

Percentage of expected questionnaire items that are missing across all required study questionnaires. Calculated as: number of unanswered items ÷ total number of expected questionnaire items × 100.

Percentage of participants who complete all required study questionnaires. Calculated as: number completing all required questionnaires ÷ number enrolled × 100.