AnxietyNCT04973956
Influence of Anxiety on Motor Learning and Motor Imagery Ability in Young Population
A study testing Relaxation in people with Anxiety, run by Susana Nunez Nagy at 4 sites in 2 countries.
Trial summary
In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Sep 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between 18 and 35 years of age.
- Normal or corrected vision specifying the method of correction.
- Normal or corrected hearing specifying method of correction.
- Unfamiliar with the assessment and uses of motor imagery.
- Presence of State-Trait Anxiety Inventory scores corresponding to anxiety.
Who cannot join
- Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months.
- Subjects with learning disabilities or problems in reading or writing.
- Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia.
- Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system.
- Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours.
- Presence of localised skin lesion or disease in the wrist area.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
University of Alcalá
Alcalá de Henares, Madrid, 28871
Complutense University of Madrid
Pozuelo de Alarcón, Madrid, 28223
European University of Madrid
Villaviciosa de Odón, Madrid, 28670
France1 site
Claude Bernard University Lyon 1
Villeurbanne, Auvergne-Rhône-Alpes, 69100
About this study
Official title: Influencia de la Ansiedad en el Aprendizaje Motor de Una Tarea Manual Precisa y en la Capacidad de Imaginación Motora
In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system.
Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working retrieval performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels.
Read more
Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. How anxiety influence the way manual tasks are learned is still unknown.
On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how a relax intervention can affect the motor imagery ability in anxiety people is still unknown.
The aim of our study was to find out whether a relaxation intervention prior to MI practice in subjects with anxiety can influence the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the anxiety participants are subjected to relaxation.
The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.
Read the detailed description
In order to meet the study objectives of determining and quantifying the effects of relax in anxiety people on learning a precise manual task and on motor imagery ability, this study will be conducted. The development of the study will take place in a conditioned room belonging to the University of Alcalá, the Complutense University of Madrid, the European University of Madrid, or Claude Bernard University Lyon 1. The study may also be carried out in other Spanish and international university centers, subject to the consent and permission of the respective centres. The study will be carried out by all national and international laws, regulations, and recommendations.
The study design will be longitudinal, experimental, randomized, and double-blind, as specified in the present registry.
The study population will be composed of participants who are undergraduate and postgraduate students at the university centers where the study will be carried out, from which the participants will be recruited. All participants included in the study must meet the study selection criteria and participate voluntarily after reading the information sheet and signing the informed consent form.
The study will consist of two intervention groups, both groups will have anxiety measured with the State-Trait Anxiety Inventory (STAI) and then be randomized to either the relaxation intervention group or the control group. Each group will consist of a minimum number of 20 subjects to be able to study the desired effect.
After each participant freely chooses to participate in the study, an initial questionnaire will be administered to ensure that the participants meet the criteria for inclusion in the study. At this point, the participants will be coded by assigning them a number, which will serve to identify each participant throughout the study. Participants will take the STAI, one of the most widely used instruments for the self-reported assessment of anxiety. Participants with scores indicative of anxiety will be included in the study. Included participants will be randomized through sealed envelopes stratified by gender to one of two experimental groups: relaxation or control. They will also take the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality, and the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery capacity. At the same time of MIQ-3, the experimenter will record the execution and imagery times were recorded (for subsequent calculation of the time discrepancy between executed and imagery as a measure of temporal congruence between them).
Depending on the group to which the participants have been assigned, the participants of the relaxation group will perform a relaxation intervention using the Abbreviated Progressive Muscle Relaxation technique (APMR). This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting. Despite its brevity, this relaxation technique has been shown to be effective in reducing anxiety and has been shown to produce cognitive, behavioral, and physiological relaxation. On the other hand, participants in the control group did not receive a relaxation intervention. After the relaxation or control, participants will learn a precise manual task with the non-dominant hand. The task will consist of going over a 127 mm circumference on a graphics tablet at a rate of 2 seconds per lap, which will be set by a metronome using a wireless pen that will leave no trace of ink but will store the data in the MATLAB program via the graphics tablet. Thus, data from the acquisition process and short-term retrieval of the task will be recorded. Afterward, there will be a 20-minute break during which participants will perform the MIQ-3 and the experimenter will record the execution and imagery times again.
In addition, during all experiments, electrodermal activity and heart rate variability will be recorded using the Empatica E4 physiological variable measurement wristband. This measurement of physiological variables will serve to confirm a significant relax effect has been generated in the relaxation group.
The analysis and processing of data from MATLAB version R2020b, and the Empatica E4 wristband will be performed using Rstudio statistical software and Kubios HRV software (for HRV analysis).
First, appropriate statistical analyses will be performed to see if the data are distributed according to a standard curve and to assess the influence of sex and age.
Subsequently, the descriptive analysis of the relative and absolute frequencies for the qualitative variables of gender and age will be carried out, and their homogeneity will be tested using the Chi-square test. The descriptive analysis of the quantitative variables of time, error, speed, accuracy, electrodermal activity, heart rate variability, motor imagery capacity and discrepancy times also be carried out. If the variable conforms to the normal, the mean, range, and standard deviation shall be calculated. If the variables do not conform to the normal, non-parametric tests will be performed.
Comparative analysis will be performed using mixed ANOVA to see the differences in the mean values respective to motor control (time, error, speed, and accuracy). A further ANOVA analysis will take place for imagery ability (motor imagery capacity and discrepancy times), comparing the results obtained at the two respective points during the experiment.
The effect of learning between laps will be analyzed by repeated-measures ANOVA comparing each motor control measurement parameter with respect to the lapping factor. Electrodermal activity, and heart rate variability during the relaxation intervention will also be studied by repeated-measures ANOVA.
For hypothesis testing, a significance level of 0.05 will be set.
- Conditions
- Anxiety
- Being tested
- Relaxation, Control
- Keywords
- Anxiety, Motor Learning, Memory, Motor Imagery Ability
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxationOther
This group will perform the APMR. This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting.
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Relaxation group | Active comparator | This group will perform the APMR Receives: Other: Relaxation |
| Control group | Active comparator | This group will perform the control intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trayectory error
It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.
Measured: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
Timing error
It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.
Measured: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
Timing accuracy
The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.
Measured: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
Task accuracy
It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.
Measured: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
Motor Imagery Capacity
This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.
Measured: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress
Discrepancy time
It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.
Measured: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress
Secondary outcomes (2)
Electrodermal Activity
The skin conductance level shall be analyzed in terms of tonic Electrodermal Activity. It shall be recorded and measured by Empatica E4 wristband.
Measured: During the procedure
Heart Rate Variability
It will be analysed in the frequency domain, in its low and high frequency bands and in the ratio between them. It shall be recorded and measured by Empatica E4 wristband.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start14 Sep 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As participants complete the State-Trait Anxiety Inventory, and are found to be anxiety, they will be randomised in parallel to one of the two intervention groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susana Nunez Nagy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, Universidad Complutense de Madrid, European University of Madrid, Claude Bernard University
- Responsible party
- Sponsor-investigator, Susana Nunez Nagy, University of Alcala
- Investigators
- Sara T Trapero Asenjo, Master, Principal investigator, University of AlcalaSusana N Núñez Nagy, PhD, Study director, University of AlcalaSara F Fernández Guinea, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973956
- Sponsor's protocol ID
- CEID2022/2/036_3
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coombes SA, Cauraugh JH, Janelle CM. Emotion and movement: activation of defensive circuitry alters the magnitude of a sustained muscle contraction. Neurosci Lett. 2006 Apr 3;396(3):192-6. doi: 10.1016/j.neulet.2005.11.048. Epub 2005 Dec 20.
PubMed 16376016Moran TP. Anxiety and working memory capacity: A meta-analysis and narrative review. Psychol Bull. 2016 Aug;142(8):831-864. doi: 10.1037/bul0000051. Epub 2016 Mar 10.
PubMed 26963369Doumas M, Morsanyi K, Young WR. Cognitively and socially induced stress affects postural control. Exp Brain Res. 2018 Jan;236(1):305-314. doi: 10.1007/s00221-017-5128-8. Epub 2017 Nov 14.
PubMed 29138872MacIntyre TE, Madan CR, Moran AP, Collet C, Guillot A. Motor imagery, performance and motor rehabilitation. Prog Brain Res. 2018;240:141-159. doi: 10.1016/bs.pbr.2018.09.010. Epub 2018 Oct 24.
PubMed 30390828Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75.
PubMed 21682867Trapero-Asenjo S, Gallego-Izquierdo T, Pecos-Martin D, Nunez-Nagy S. Translation, cultural adaptation, and validation of the Spanish version of the Movement Imagery Questionnaire-3 (MIQ-3). Musculoskelet Sci Pract. 2021 Feb;51:102313. doi: 10.1016/j.msksp.2020.102313. Epub 2020 Dec 9.
PubMed 33310512Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.
PubMed 5146491Trapero-Asenjo S, Fernandez-Guinea S, Guillot A, Pecos-Martin D, Nunez-Nagy S. Muscle relaxation enhances motor imagery capacity in people with anxiety: A randomized clinical trial. PLoS One. 2025 Jan 10;20(1):e0316723. doi: 10.1371/journal.pone.0316723. eCollection 2025.
PubMed 39792894
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencia de la Ansiedad en el Aprendizaje Motor de Una Tarea Manual Precisa y en la Capacidad de Imaginación Motora
- ClinicalTrials.gov ID
- NCT04973956
- Acronym / sponsor ID
- CEID2022/2/036_3
- Conditions
- Anxiety
- Keywords
- Anxiety, Motor Learning, Memory, Motor Imagery Ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Susana Nunez NagyUniversity, hospital or other
- Collaborators
- University of Alcala, Universidad Complutense de Madrid, European University of Madrid, Claude Bernard University
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system.
Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working retrieval performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels.
Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. How anxiety influence the way manual tasks are learned is still unknown.
On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how a relax intervention can affect the motor imagery ability in anxiety people is still unknown.
The aim of our study was to find out whether a relaxation intervention prior to MI practice in subjects with anxiety can influence the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the anxiety participants are subjected to relaxation.
The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.
Detailed description
In order to meet the study objectives of determining and quantifying the effects of relax in anxiety people on learning a precise manual task and on motor imagery ability, this study will be conducted. The development of the study will take place in a conditioned room belonging to the University of Alcalá, the Complutense University of Madrid, the European University of Madrid, or Claude Bernard University Lyon 1. The study may also be carried out in other Spanish and international university centers, subject to the consent and permission of the respective centres. The study will be carried out by all national and international laws, regulations, and recommendations.
The study design will be longitudinal, experimental, randomized, and double-blind, as specified in the present registry.
The study population will be composed of participants who are undergraduate and postgraduate students at the university centers where the study will be carried out, from which the participants will be recruited. All participants included in the study must meet the study selection criteria and participate voluntarily after reading the information sheet and signing the informed consent form.
The study will consist of two intervention groups, both groups will have anxiety measured with the State-Trait Anxiety Inventory (STAI) and then be randomized to either the relaxation intervention group or the control group. Each group will consist of a minimum number of 20 subjects to be able to study the desired effect.
After each participant freely chooses to participate in the study, an initial questionnaire will be administered to ensure that the participants meet the criteria for inclusion in the study. At this point, the participants will be coded by assigning them a number, which will serve to identify each participant throughout the study. Participants will take the STAI, one of the most widely used instruments for the self-reported assessment of anxiety. Participants with scores indicative of anxiety will be included in the study. Included participants will be randomized through sealed envelopes stratified by gender to one of two experimental groups: relaxation or control. They will also take the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality, and the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery capacity. At the same time of MIQ-3, the experimenter will record the execution and imagery times were recorded (for subsequent calculation of the time discrepancy between executed and imagery as a measure of temporal congruence between them).
Depending on the group to which the participants have been assigned, the participants of the relaxation group will perform a relaxation intervention using the Abbreviated Progressive Muscle Relaxation technique (APMR). This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting. Despite its brevity, this relaxation technique has been shown to be effective in reducing anxiety and has been shown to produce cognitive, behavioral, and physiological relaxation. On the other hand, participants in the control group did not receive a relaxation intervention. After the relaxation or control, participants will learn a precise manual task with the non-dominant hand. The task will consist of going over a 127 mm circumference on a graphics tablet at a rate of 2 seconds per lap, which will be set by a metronome using a wireless pen that will leave no trace of ink but will store the data in the MATLAB program via the graphics tablet. Thus, data from the acquisition process and short-term retrieval of the task will be recorded. Afterward, there will be a 20-minute break during which participants will perform the MIQ-3 and the experimenter will record the execution and imagery times again.
In addition, during all experiments, electrodermal activity and heart rate variability will be recorded using the Empatica E4 physiological variable measurement wristband. This measurement of physiological variables will serve to confirm a significant relax effect has been generated in the relaxation group.
The analysis and processing of data from MATLAB version R2020b, and the Empatica E4 wristband will be performed using Rstudio statistical software and Kubios HRV software (for HRV analysis).
First, appropriate statistical analyses will be performed to see if the data are distributed according to a standard curve and to assess the influence of sex and age.
Subsequently, the descriptive analysis of the relative and absolute frequencies for the qualitative variables of gender and age will be carried out, and their homogeneity will be tested using the Chi-square test. The descriptive analysis of the quantitative variables of time, error, speed, accuracy, electrodermal activity, heart rate variability, motor imagery capacity and discrepancy times also be carried out. If the variable conforms to the normal, the mean, range, and standard deviation shall be calculated. If the variables do not conform to the normal, non-parametric tests will be performed.
Comparative analysis will be performed using mixed ANOVA to see the differences in the mean values respective to motor control (time, error, speed, and accuracy). A further ANOVA analysis will take place for imagery ability (motor imagery capacity and discrepancy times), comparing the results obtained at the two respective points during the experiment.
The effect of learning between laps will be analyzed by repeated-measures ANOVA comparing each motor control measurement parameter with respect to the lapping factor. Electrodermal activity, and heart rate variability during the relaxation intervention will also be studied by repeated-measures ANOVA.
For hypothesis testing, a significance level of 0.05 will be set.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- As participants complete the State-Trait Anxiety Inventory, and are found to be anxiety, they will be randomised in parallel to one of the two intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Relaxation group | Active comparator | Other: RelaxationThis group will perform the APMR |
| Control group | Active comparator | Other: ControlThis group will perform the control intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women between 18 and 35 years of age.
- Normal or corrected vision specifying the method of correction.
- Normal or corrected hearing specifying method of correction.
- Unfamiliar with the assessment and uses of motor imagery.
- Presence of State-Trait Anxiety Inventory scores corresponding to anxiety.
Key exclusion criteria (6 listed)
- Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months.
- Subjects with learning disabilities or problems in reading or writing.
- Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia.
- Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system.
- Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelaxationThis group will perform the APMR. This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting. | Other | Relaxation group |
| ControlNo intervention | Other | Control group |
Primary outcome
Trayectory error
Time frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.
Timing error
Time frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.
Timing accuracy
Time frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.
Task accuracy
Time frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval
It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.
Motor Imagery Capacity
Time frame: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress
This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.
Discrepancy time
Time frame: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress
It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.
2 secondary outcomes
Electrodermal Activity
Time frame: During the procedure
Heart Rate Variability
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 16376016Coombes SA, Cauraugh JH, Janelle CM. Emotion and movement: activation of defensive circuitry alters the magnitude of a sustained muscle contraction. Neurosci Lett. 2006 Apr 3;396(3):192-6. doi: 10.1016/j.neulet.2005.11.048. Epub 2005 Dec 20.
- Background: PubMed 26963369Moran TP. Anxiety and working memory capacity: A meta-analysis and narrative review. Psychol Bull. 2016 Aug;142(8):831-864. doi: 10.1037/bul0000051. Epub 2016 Mar 10.
- Background: PubMed 29138872Doumas M, Morsanyi K, Young WR. Cognitively and socially induced stress affects postural control. Exp Brain Res. 2018 Jan;236(1):305-314. doi: 10.1007/s00221-017-5128-8. Epub 2017 Nov 14.
- Background: PubMed 30390828MacIntyre TE, Madan CR, Moran AP, Collet C, Guillot A. Motor imagery, performance and motor rehabilitation. Prog Brain Res. 2018;240:141-159. doi: 10.1016/bs.pbr.2018.09.010. Epub 2018 Oct 24.
- Background: PubMed 21682867Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75.
- Background: PubMed 33310512Trapero-Asenjo S, Gallego-Izquierdo T, Pecos-Martin D, Nunez-Nagy S. Translation, cultural adaptation, and validation of the Spanish version of the Movement Imagery Questionnaire-3 (MIQ-3). Musculoskelet Sci Pract. 2021 Feb;51:102313. doi: 10.1016/j.msksp.2020.102313. Epub 2020 Dec 9.
- Background: PubMed 5146491Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.
- Derived from this study: PubMed 39792894Trapero-Asenjo S, Fernandez-Guinea S, Guillot A, Pecos-Martin D, Nunez-Nagy S. Muscle relaxation enhances motor imagery capacity in people with anxiety: A randomized clinical trial. PLoS One. 2025 Jan 10;20(1):e0316723. doi: 10.1371/journal.pone.0316723. eCollection 2025.
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Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara T Trapero Asenjo, Master principal investigator
University of Alcala
Susana N Núñez Nagy, PhD study director
University of Alcala
Sara F Fernández Guinea, PhD study director
Universidad Complutense de Madrid
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation in people with Anxiety, run by Susana Nunez Nagy at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trayectory error (time frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973956, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.