UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057560 |
|---|---|
| Receipt number | R000065770 |
| Scientific Title | A Preliminary Randomized Controlled Trial Investigating the Psychophysiological Effects of Fire Observation in Healthy Individuals |
| Date of disclosure of the study information | 2025/04/09 |
| Last modified on | 2025/04/09 11:54:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effects of Watching Fire on the Brain and Mind
Acronym
Fire Observation and Its Effects on the Brain and Mind
Scientific Title
A Preliminary Randomized Controlled Trial Investigating the Psychophysiological Effects of Fire Observation in Healthy Individuals
Scientific Title:Acronym
Pilot Study on the Psychophysiological Effects of Fire Observation
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that engaging in campfire activities would help participants focus their attention on the flames, potentially reducing anxiety, restlessness, and tension. To test this hypothesis, we planned a preliminary study with healthy participants, where they would observe the actual flames of a lantern and evaluate its effects from various perspectives.
To assess the psychological effects of flame observation, we will use the Profile of Mood States 2nd Edition (POMS2) to evaluate mood, the State-Trait Anxiety Inventory (STAI) to measure anxiety, and a short-form self-report measure (S-MARE) to assess relaxation. POMS2 will evaluate mood states such as tension and depression, STAI will measure both state and trait anxiety, and S-MARE will assess physiological tension, psychological calmness, and cognitive anxiety.
For objective evaluation, we will measure neural and physiological indicators of attention and focus on the flame using neurophysiological measures. During the observation, we will assess brainwaves, including Frontal Midline Theta Rhythm (FmTheta), Frontal Alpha Asymmetry (FAA), and Temporal Gamma (TG). FmTheta reflects concentration, FAA reflects motivation, and TG indicates anxiety. Additionally, we will measure salivary alpha-amylase activity (SAA) as a stress indicator, and heart rate (HR) to assess changes in autonomic nervous system activity during the flame observation.
Basic objectives2
Others
Basic objectives -Others
Our primary objective is to comprehensively evaluate the effects of fire observation on individuals using psychological, neurophysiological, and physiological indicators, and to clarify these effects. Additionally, based on the results, we will explore the potential applicability of real fire in clinical and other practical settings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure will be a short form self-report measure to assess the relaxation effects (S-MARE). In the intervention group, participants will gaze at a lantern flame for 30 minutes, while in the non-intervention group, participants will gaze at the direction of a lantern without a flame for 30 minutes. The subscale and total scores will be assessed before and after gazing at the lantern, and the mean values will be compared and analyzed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In this study, "fire observation" is defined as watching the flame of an alcohol lantern for 30 minutes.
Subjective evaluations, including POMS 2, S-MARE, and STAI, will be conducted before and after the fire observation.
As a physiological measure, salivary alpha-amylase (SAA) will be collected.
During the fire observation, EEG indices such as frontal alpha asymmetry (FAA), frontal midline theta (FM theta), and temporal gamma activity will be recorded, along with heart rate and a visual analog scale (VAS) measured every 10 minutes.
Interventions/Control_2
Participants will observe the direction of a lantern without a flame for 30 minutes.
Subjective evaluations, including POMS 2, S-MARE, and STAI, will be conducted before and after the observation.
Salivary alpha-amylase (SAA) will be measured as a physiological assessment.
Regardless of whether the flame is observed or not, EEG indices such as frontal alpha asymmetry (FAA), frontal midline theta (FM theta), and temporal gamma activity will be recorded, along with heart rate and a visual analog scale (VAS) measured every 10 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older at the time of consent acquisition.
Individuals who have agreed to participate in this study.
Key exclusion criteria
Individuals with brain organic diseases due to trauma or a diagnosis of epilepsy.
Individuals taking medications that affect brain function, including antipsychotic drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | miura |
| Middle name | |
| Last name | itaru |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima
TEL
024-547-1331
itaru@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takahashi |
| Middle name | |
| Last name | Yuichi |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima
TEL
024-547-1331
Homepage URL
c0000980@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department for the Promotion of Medical Research
Address
1 Hikarigaoka, Fukushima City, Fukushima
Tel
024-547-1825
fmurec@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065770
