- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234006
Neurofeedback-mindfulness Techniques on Anxiety, Stress, and Academic Performance of Nursing Students
EFFECT OF NEUROFEEDBACK-MINDFULNESS TECHNIQUES ON ANXIETY, STRESS, AND ACADEMIC PERFORMANCE OF NURSING STUDENTS
In today's society, anxiety and stress are prevalent emotional responses in mental health globally, significantly affecting students' well-being and academic performance. In particular, undergraduate nursing students face high levels of these problems due to the heavy academic workload and demands of their training, especially during exam periods. The need for concentration, emotional management, and decision-making under pressure contribute to the prevalence of these disorders, impacting both their quality of life and academic performance.
Despite the existence of multiple strategies and techniques for managing these issues, it is still necessary to continue exploring innovative alternatives that complement traditional interventions. For this reason, this project aims to evaluate the effectiveness of mindfulness-neurofeedback as a treatment to reduce stress and anxiety in nursing students, with the goal of providing scientific evidence on this intervention. This brain training technique is presented as a promising option, based on the modulation of brain activity, with the potential to improve emotional regulation and concentration in the educational setting.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: José Ignacio Recio Rodriguez, Doctor
- Phone Number: +34650330694
- Email: donrecio@usal.es
Study Locations
-
-
-
Salamanca, Spain
- Recruiting
- Faculty of Nursing
-
Contact:
- Jose I Recio-Rodriguez
- Phone Number: 650330694
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students enrolled in the nursing degree at the University of Salamanca
- Aged between 18 and 45 years
- Willing to voluntarily participate in the study and sign the informed consent form.
Exclusion Criteria:
- History of serious psychiatric disorders in the 6 months prior to inclusion in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: No intervention
|
No intervention
|
|
Experimental: NEUROFEEDBACK-MINDFULNESS
Neurofeedback-Assisted Mindfulness Training Program
|
The Neurofeedback-Assisted Mindfulness Training sessions will be given to the intervention group participants after randomization. Each session will vary in length depending on the session, but will last a maximum of 20 minutes. A total of 20 sessions will be held at the participant's home, preferably in the afternoon, at a rate of 5 sessions per week for 4 weeks after randomization. The organization of the sessions is described in the following table of this study's protocol. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Mean of the Depression, anxiety and stress scale at 4 weeks
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Zero is equivalent to no symptoms and 63 indicates the worst possible symptoms
|
From enrollment to the end of treatment at 4 weeks
|
|
Change from Baseline in the Mean Academic performance score at 4 weeks
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Zero is equivalent to the best academic performance and 40 indicates the worst academic performance
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBYP25/034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Center for Advanced Facial Plastic SurgeryCompletedStress | Stress, Physiological | Stress Response | Stress (Psychology) | Healthy Adult Female Participants | Stress, Psychologic | Stress Perception | Stress Levels | Stress, Psychological CumulativeUnited States
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
Canterbury Christ Church UniversitySussex Partnership NHS Foundation TrustEnrolling by invitationOccupational Stress or Workplace StressUnited Kingdom
-
University of PadovaCompletedStress | Stress Disorder | Work Related StressItaly
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
University of North Carolina, Chapel HillWashington University School of Medicine; United States Department of Defense; University of Florida and other collaboratorsRecruitingPost-traumatic Stress Disorder | Acute Stress Disorder | Acute Stress ReactionUnited States
-
University of Auckland, New ZealandNot yet recruiting
Clinical Trials on No intervention
-
Hopital FochNot yet recruitingInterstitial Lung DiseaseFrance
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... and other collaboratorsRecruitingHead and Neck Squamous Cell Carcinoma | Patient Derived Organoid | Drug Sensitive Test in VitroChina
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown