Clinical trial NCT06849700: Effects of Active Gamification on Sleep and Anxiety in Primary School Children
Official title: Can Active Gamification Improve Sleep and Reduce Anxiety in Children in Primary Education?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Students
Metal Health
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Active gamification, which incorporates game elements with physical interaction, is presented as an innovative strategy to address anxiety problems and sleep quality in children. There is evidence to suggest that physical activity and structured play can positively influence emotional regulation and sleep hygiene, which makes it relevant to explore interventions based on this methodology within the educational field. This study aims to evaluate the impact of an active gamification program on these variables in children in Primary Education. To do so, a randomized controlled trial will be carried out with the participation of 120 children between 8 and 11 years of age. Participants will be randomly assigned to one of two groups: an experimental group, which will participate in a program designed to promote physical activity through game dynamics for 12 weeks, and a control group, which will continue with traditional physical education classes without modifications to their usual methodology. The implementation of the program includes structured sessions with activities designed to encourage interaction, movement and decision-making within a playful environment, in order to enhance children's commitment and adherence to the intervention.


Eligibility criteria: Inclusion Criteria:

* Age between 8 and 11 years
* No medical contraindication for physical activity
* No intellectual disability that could interfere with understanding or compliance with the study procedures; and iv) informed consent from parents or legal guardians.

Those students who did not meet the inclusion criteria were able to participate in the intervention with their peers, but were not considered in the analysis.

Exclusion Criteria:

* Diagnosis of neuromotor disorder or severe physical disability that limits participation in the scheduled physical activity
* Presence of severe psychological or behavioral disorders that make integration into group activities difficult.
* Use of medication that significantly affects physical or cognitive performance.
* Failure to attend more than 20% of the intervention program sessions
* Withdrawal of informed consent by parents or legal guardians during the study

Primary outcomes:
measure: Anxiety
timeFrame: Up to twelve weeks
measure: Sleep quality
timeFrame: Up to twelve weeks
measure: Self-Esteem
timeFrame: Up to twelve weeks
measure: Self-Concept
timeFrame: Up to twelve weeks
measure: Social Skills
timeFrame: Up to twelve weeks
measure: Concentration and Selective Attention
timeFrame: Up to twelve weeks
measure: Creativity
timeFrame: Up to twelve weeks
measure: Memory
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Agustín Aibar Almazán
Study officials:
References: