NCT07089537

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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 Start

First participant enrolled

February 24, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

March 13, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Electroencephalography

    Analysis of changes in EEG band power excitability across the frontal, central, and occipital brain regions.

    20 min in total

Secondary Outcomes (3)

  • Muscle tension

    15 mins

  • heart rate variability

    20 mins in total

  • Self-Assessment Manikin

    1min

Study Arms (2)

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.

Other: progressive muscle relaxaitonOther: Rest

rest

PLACEBO COMPARATOR

rest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention.

Other: progressive muscle relaxaitonOther: Rest

Interventions

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.

progressive muscle relaxationrest
RestOTHER

Rest in a semi-recumbent position with eyes closed for 30 minutes, without any additional intervention.

progressive muscle relaxationrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807378, Taiwan

RECRUITING

MeSH Terms

Interventions

RE1-silencing transcription factor

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

March 13, 2025

First Posted

July 28, 2025

Study Start

February 24, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations