Progressive Muscle RelaxationNCT07089537
Acute Effects of Progressive Muscle Relaxation on Brain Waves
A study testing progressive muscle relaxaiton and Rest in people with Progressive Muscle Relaxation, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
In modern environments, stress is present regardless of age or social role. Stress does not always have negative effects; in fact, it is a necessary response for survival, known as the stress response. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Muscle Relaxation
- What is being tested?
- progressive muscle relaxaiton and Rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Age: 18 years and above
- Body Mass Index (BMI) between 18 and 24
- Able to remain in a semi-recumbent position for 2 hours
Who cannot join
- Individuals with communication impairments or difficulty understanding instructions
- Color vision deficiency
- Open wounds or injuries on the scalp
- Currently taking medications that affect cardiovascular or autonomic nervous system regulation
- Muscle strain or pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City, 807378
Prof. Hsu, 886+73121101 ext. 2673, mjhsu@kmu.edu.tw
Hsinyu Sun, 886+989663315, bearcat97203@gmail.com
About this study
Official title: Acute Effects of Progressive Muscle Relaxation on Brain Waves, Heart Rate Variability, Muscle Tone, and Mental Stress
In modern environments, stress is present regardless of age or social role. Stress does not always have negative effects; in fact, it is a necessary response for survival, known as the stress response. This response includes increased heart rate, blood pressure, blood glucose levels, and decreased alpha brainwave activity. These physiological changes are primarily regulated by the sympathetic and parasympathetic branches of the autonomic nervous system, enabling us to cope with environmental threats. However, when the stress response system becomes overwhelmed or imbalanced-whether due to accumulated chronic stress or acute stress-it may result in adverse effects on both physical and mental health.
Relaxation techniques are non-pharmacological methods that promote parasympathetic nervous system activity. The goal is to reduce excessive arousal, alleviate anxiety, slow down thought processes, and relieve stress, thereby achieving relaxation in a natural way. These methods help lower blood pressure, improve circulation, relax muscles, and enhance concentration. Previous studies have demonstrated a correlation between relaxation and attention, suggesting that relaxation can improve attentional efficiency. Moreover, it is well-documented that executive function tends to decline under stress. Relaxation techniques are commonly incorporated into psychological therapies, yet they are more accessible, easier to practice, and can be conveniently performed at home.
Therefore, the aim of this study is to investigate whether PMR can produce immediate relaxation effects as measured by EEG (cortical excitability), heart rate variability, and muscle tone, and whether it can improve performance under psychological stress. The goal is to further explore the potential application of PMR in healthy populations facing acute stress conditions.
- Conditions
- Progressive Muscle Relaxation
- Being tested
- progressive muscle relaxaiton, Rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxaitonOther
Participants will undergo approximately 30 minutes of Progressive Muscle Relaxation (PMR). Prior to the session, a brief introduction to the basic concepts of PMR will be provided. Participants will be instructed to close their eyes and focus on the sensations in their muscles. Following verbal instructions, they will sequentially contract and relax 14 major muscle groups from top to bottom. For each muscle group, participants will be asked to contract the muscles as strongly as possible for 7 seconds, followed by a 45-second relaxation period. This process will be repeated twice for each muscle group.
RestOther
Rest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| progressive muscle relaxation | Experimental | Participants will undergo approximately 30 minutes of Progressive Muscle Relaxation (PMR). Prior to the session, a brief introduction to the basic concepts of PMR will be provided. Participants will be instructed to close their eyes and focus on the sensations in their muscles. Following verbal instructions, they will sequentially contract and relax 14 major muscle groups from top to bottom. For each muscle group, participants will be asked to contract the muscles as strongly as possible for 7 seconds, followed by a 45-second relaxation period. This process will be repeated twice for each muscle group. Receives: Other: progressive muscle relaxaiton; Other: Rest |
| rest | Placebo comparator | rest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention. Receives: Other: progressive muscle relaxaiton; Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography
Analysis of changes in EEG band power excitability across the frontal, central, and occipital brain regions.
Measured: 20 min in total
Secondary outcomes (3)
Muscle tension
Changes in muscle tension
Measured: 15 mins
heart rate variability
changes in frequency domain heart rate variability
Measured: 20 mins in total
Self-Assessment Manikin
Whether the subjective emotion is calm or excited
Measured: 1min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start24 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle RelaxationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsinyu Sun, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089537
- Sponsor's protocol ID
- KMUHIRB-E(I)-20240388
- Status last verified
- Jul 2025
- First submitted
- 13 Mar 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Progressive Muscle Relaxation on Brain Waves, Heart Rate Variability, Muscle Tone, and Mental Stress
- ClinicalTrials.gov ID
- NCT07089537
- Acronym / sponsor ID
- KMUHIRB-E(I)-20240388
- Conditions
- Progressive Muscle Relaxation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (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 modern environments, stress is present regardless of age or social role. Stress does not always have negative effects; in fact, it is a necessary response for survival, known as the stress response. This response includes increased heart rate, blood pressure, blood glucose levels, and decreased alpha brainwave activity. These physiological changes are primarily regulated by the sympathetic and parasympathetic branches of the autonomic nervous system, enabling us to cope with environmental threats. However, when the stress response system becomes overwhelmed or imbalanced-whether due to accumulated chronic stress or acute stress-it may result in adverse effects on both physical and mental health.
Relaxation techniques are non-pharmacological methods that promote parasympathetic nervous system activity. The goal is to reduce excessive arousal, alleviate anxiety, slow down thought processes, and relieve stress, thereby achieving relaxation in a natural way. These methods help lower blood pressure, improve circulation, relax muscles, and enhance concentration. Previous studies have demonstrated a correlation between relaxation and attention, suggesting that relaxation can improve attentional efficiency. Moreover, it is well-documented that executive function tends to decline under stress. Relaxation techniques are commonly incorporated into psychological therapies, yet they are more accessible, easier to practice, and can be conveniently performed at home.
Therefore, the aim of this study is to investigate whether PMR can produce immediate relaxation effects as measured by EEG (cortical excitability), heart rate variability, and muscle tone, and whether it can improve performance under psychological stress. The goal is to further explore the potential application of PMR in healthy populations facing acute stress conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive muscle relaxation | Experimental | Other: progressive muscle relaxaiton, Other: RestParticipants will undergo approximately 30 minutes of Progressive Muscle Relaxation (PMR). Prior to the session, a brief introduction to the basic concepts of PMR will be provided. Participants will be instructed to close their eyes and focus on the sensations in their muscles. Following verbal instructions, they will sequentially contract and relax 14 major muscle groups from top to bottom. For each muscle group, participants will be asked to contract the muscles as strongly as possible for 7 seconds, followed by a 45-second relaxation period. This process will be repeated twice for each muscle group. |
| rest | Placebo comparator | Other: progressive muscle relaxaiton, Other: Restrest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults
- Age: 18 years and above
- Body Mass Index (BMI) between 18 and 24
- Able to remain in a semi-recumbent position for 2 hours
Key exclusion criteria (5 listed)
- Individuals with communication impairments or difficulty understanding instructions
- Color vision deficiency
- Open wounds or injuries on the scalp
- Currently taking medications that affect cardiovascular or autonomic nervous system regulation
- Muscle strain or pain
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 |
|---|---|---|
| progressive muscle relaxaitonParticipants will undergo approximately 30 minutes of Progressive Muscle Relaxation (PMR). Prior to the session, a brief introduction to the basic concepts of PMR will be provided. Participants will be instructed to close their eyes and focus on the sensations in their muscles. Following verbal instructions, they will sequentially contract and relax 14 major muscle groups from top to bottom. For each muscle group, participants will be asked to contract the muscles as strongly as possible for 7 seconds, followed by a 45-second relaxation period. This process will be repeated twice for each muscle group. | Other | progressive muscle relaxation, rest |
| RestRest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention. | Other | progressive muscle relaxation, rest |
Primary outcome
Electroencephalography
Time frame: 20 min in total
Analysis of changes in EEG band power excitability across the frontal, central, and occipital brain regions.
3 secondary outcomes
Muscle tension
Time frame: 15 mins
heart rate variability
Time frame: 20 mins in total
Self-Assessment Manikin
Time frame: 1min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxaiton and Rest in people with Progressive Muscle Relaxation, run by Kaohsiung Medical University at 1 site in Taiwan.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miaoju Hsu (886+73121101 ext. 2673, mjhsu@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (time frame: 20 min in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.