- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05452629
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
35
Phase
- 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
-
-
-
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
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- track and field athletes with regular training
- right-handedness
- no history of neurological illness
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Induction
A brief and single session of mindfulness practice for 30-minute.
|
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.
|
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
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.
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)
July 14, 2020
Primary Completion (Actual)
March 19, 2021
Study Completion (Actual)
March 19, 2021
Study Registration Dates
First Submitted
July 6, 2022
First Submitted That Met QC Criteria
July 6, 2022
First Posted (Actual)
July 11, 2022
Study Record Updates
Last Update Posted (Actual)
July 11, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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