Effect of Brief Mindfulness and Relaxation Inductions on Anxiety, Affect and Brain Activation in Athletes

July 6, 2022 updated by: National Taiwan Normal University
The athlete population has a high risk of suffering from mental health problems (e.g., anxiety), especially for athletes with individual sports. As such, various forms of mental training were used to maintain the mental health of athletes, such as mindfulness training or relaxation training. However, differences pertaining to the electrophysiological mechanisms resulting from both mental training in athletes are unknown. Therefore, the purpose of the current study was to examine the differential effects between the brief mindfulness induction (MI) and relaxation induction (RI) on state anxiety, affect and the activation of the brain in track and field athletes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purposes of this study are: (1) examining the effect of brief mindfulness induction (MI) and relaxation induction (RI) on anxiety and affect in athletes with individual sports, (2) and we sought to identify the different brain activity (i.e., theta, alpha) changes between MI and RI using EEG. In the present study, subjects were contrasted using a within-subject comparison across MI, RI, and control condition. According to past works on the comparison of mindfulness and psychological skill training, we hypothesized that MI and RI would both improve anxiety and affect, compared with control condition. Furthermore, we also hypothesized that RI would elicit greater theta power (i.e., more cognitive control) than MI. In addition, when compared with control condition, participants might be elicited greater alpha power during the MI and RI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Yu-Kai Chang, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. track and field athletes with regular training
  2. right-handedness
  3. no history of neurological illness
  4. no regular training experience in mindfulness or relaxation interventions

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Induction
A brief and single session of mindfulness practice for 30-minute.
Behavioral: Mindfulness induction (MI)
In the MI condition, participants were guided to focus on present experiences regarding the thoughts, emotions and sensations through the three classic mindfulness exercises (i.e., focused breathing, meditation, and body scanning). The duration of MI was 30-minutes.
Experimental: Relaxation Induction
A brief and single session of self-directed relaxation for 30-minute.
Behavioral: Relaxation (RI)
In the RI condition, participants were guided to relax each muscle group following the audio for 30-minutes.
No Intervention: Control Condition
Open thinking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State anxiety
Time Frame: 10 minutes
The Chinese version of the State-Trait Anxiety Inventory (C-STAI, Wang & Chung, 2016), which is based on the State-Trait Anxiety Inventory (STAI, Spielberger, 1970), was utilized to assess an individual's alteration of state anxiety before and after each experimental manipulation in current study. The State Anxiety Inventory (SAI) is a 20-item sub-scales in the STAI, with a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) used for each item. Higher total scores indicate higher levels of state anxiety.
10 minutes
Affective state
Time Frame: 5 minutes
The Positive and Negative Affect Schedule (PANAS) was utilized to assess an individual's alteration of PA and NA before and after each experimental manipulation in current study. PANAS is a 20-items questionnaire that consists of two 10-item mood scales assessing the positively affective states (i.e., PA) and negatively affective states (i.e., NA), respectively. Participants were asked to rate to what extent they felt a certain way right now from 1 (not at all) to 5 (extremely). Higher total scores indicate higher intensity of affective state.
5 minutes
EEG
Time Frame: 30 minutes
The selected frequency bands were as theta (4-8 Hz) and alpha (8-13 Hz), the frequency bands were computed by averaged across epochs and integrated spectral power, the frontal region (Fp1, Fp2, F7, F3, Fz, F4, F8) for theta power, and posterior region (P7, P3, Pz, P4, P8, O1, Oz, O2) for alpha power were selected into the statistical analysis, respectively.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PACNL_JT_MI_EEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings