Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101225
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-05
Brief Title:
Effects of a Relaxation and Guided Imagery Intervention in School Context
Sponsor:
Universidade Autónoma de Lisboa
Organization:
Universidade Autónoma de Lisboa
Study Overview
Official Title:
RCT of the Effects of a Relaxation Guided Imagery Intervention and Socioemotional Learning on the Psychophysiological Well-being Socioemotional Regulation Cognitive and Academic Development of Children in School
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MR
Brief Summary:
Specific aims - To test the effects of a relaxation and guided imagery intervention with socioemotional learning content on a range of socioemotional physiological cognitive and academic outcomes of school-aged children measured through self-reports neuropsychological and physiological measures as well as teachers and parents reports
Detailed Description:
Background Mental imagery has long been used in psychological therapies but only recently has research started to provide a relevant scientific basis Imagery interventions are inexpensive and have a body of research supporting their effectiveness on behavior change the promotion of adaptive health outcomes the reduction of anxiety and adherence to medical interventions in adults and children However literature on the relaxation and guided imagery interventions benefits for children in elementary school context is very scarce This Randomized Controlled Trial RCT aims to contribute to the body of research by implementing and testing the benefits of an intervention program MindRegulation composed of relaxation instructions for body posture and guided imagery with socioemotional learning SEL conveying adaptive beliefs about oneself the relationships with others and the environment
Method The MindRegulation intervention will be developed in the classroom for 15 minutes before learning activities three times per week for five months and its effects will be measured on a range of emotional physiologic and cognitive outcomes Twelve classes will be randomly distributed into three conditions a relaxation and guided imagery b just relaxation and c waitlist control The RCT includes four data collection times pretest intermediate posttest and a six-month follow-up The sample comprises 240 students third and fourth graders from elementary school between 8 and 11 years old The variables measured in the study are well-being affect anxiety emotional regulation socioemotional competencies attention and processing speed physiologic responses of arousal stress and well-being and perceived benefits of the intervention The psychometric properties of the subjective measures show they are adequate for the study population and language except for the self-esteem scale that will be validated to the study target population
Discussion Improvements on the childrens well-being socioemotional regulation cognitive function physiologic activity and academic performance are expected after five months of MindRegulation intervention and changes on physiologic activity are expected during each MindRegulation session Mediation effects are expected for emotional regulation well-being and anxiety variables from participating in the intervention in the outcome variables such as socioemotional competence cognitive function and academic performance Additionally well-being and anxiety levels at pretest are expected to moderate the intervention effects
Method The MindRegulation intervention will be developed in the classroom for 15 minutes before learning activities three times per week for five months and its effects will be measured on a range of emotional physiologic and cognitive outcomes Twelve classes will be randomly distributed into three conditions a relaxation and guided imagery b just relaxation and c waitlist control The RCT includes four data collection times pretest intermediate posttest and a six-month follow-up The sample comprises 240 students third and fourth graders from elementary school between 8 and 11 years old The variables measured in the study are well-being affect anxiety emotional regulation socioemotional competencies attention and processing speed physiologic responses of arousal stress and well-being and perceived benefits of the intervention The psychometric properties of the subjective measures show they are adequate for the study population and language except for the self-esteem scale that will be validated to the study target population
Discussion Improvements on the childrens well-being socioemotional regulation cognitive function physiologic activity and academic performance are expected after five months of MindRegulation intervention and changes on physiologic activity are expected during each MindRegulation session Mediation effects are expected for emotional regulation well-being and anxiety variables from participating in the intervention in the outcome variables such as socioemotional competence cognitive function and academic performance Additionally well-being and anxiety levels at pretest are expected to moderate the intervention effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None