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Effects of a Relaxation and Guided Imagery Intervention in School Context (MR)

U

Universidade Autónoma de Lisboa

Status

Enrolling

Conditions

Self Esteem
Happiness
Physical Activity
Cognitive Change
Mental Health Wellness 1
Heart Rate Variability
Social Skills
Self-Regulation, Emotion
Positive and Negative Affect
Anxiety
Stress, Psychological

Treatments

Other: Waiting List Control Group
Other: MindRegulation Intervention
Other: Relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT06101225
MindRegulation BIAL212/22

Details and patient eligibility

About

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 parent's reports.

Full 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 children's 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.

Enrollment

240 estimated patients

Sex

All

Ages

7 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Attend the 3rd and 4th grade of the selected school (8-11 years-old)

Exclusion criteria

  • The participant classes have benefited from the RegularMind intervention previously;
  • Not being able to provide self-report due to intellectual, physical or sensory disabilities.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 3 patient groups

RegularMente Intervention
Experimental group
Description:
1. Relaxation exercises, breathing and closing the eyes, focusing on body parts; 2. The proposal of a guided imagery through narrated scripts, leading children through the visualization of beautiful scenarios and exposure to Social and Emotional Learning content - based on the Collaborative for Academic, Social, and Emotional Learning framework (CASEL), in three major themes: Me with myself (self-awareness and self-management); Me with the others (social-awareness and relationships skills); Me with the world (responsible decision making and social awareness); 3. Instructions for self-regulation of body posture and the use of touch (shoulders) to support children in posture regulation.
Treatment:
Other: MindRegulation Intervention
Relaxation
Active Comparator group
Description:
Relaxation exercises, breathing and closing the eyes, focusing on body parts.
Treatment:
Other: Relaxation
Control
Other group
Description:
No intervention - regular school activities.
Treatment:
Other: Waiting List Control Group

Trial contacts and locations

1

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Central trial contact

Cristina Dias, Phd; Iolanda C. Galinha, Phd

Data sourced from clinicaltrials.gov

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