NCT07234006

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
0mo left

Started Nov 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Nov 2025May 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in the Mean of the Depression, anxiety and stress scale 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

    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

Study Arms (2)

No intervention

OTHER

No intervention

Other: No intervention

NEUROFEEDBACK-MINDFULNESS

EXPERIMENTAL

Neurofeedback-Assisted Mindfulness Training Program

Behavioral: NEUROFEEDBACK-MINDFULNESS

Interventions

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.

NEUROFEEDBACK-MINDFULNESS

No intervention

No intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Salamanca, Spain

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

José Ignacio Recio Rodriguez, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

November 21, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations