UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058343 |
|---|---|
| Receipt number | R000066685 |
| Scientific Title | Effects of Nurses' Eye Contact on Autonomic Nervous System Activity and Subjective Impressions in Participants |
| Date of disclosure of the study information | 2025/07/04 |
| Last modified on | 2025/07/02 12:02:50 |
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Basic information
Public title
Effects of Nurses' Eye Contact on Autonomic Nervous System Activity and Subjective Impressions in Participants
Acronym
Effects of Nurses' Eye Contact on Participants' Nervousness and Impressions
Scientific Title
Effects of Nurses' Eye Contact on Autonomic Nervous System Activity and Subjective Impressions in Participants
Scientific Title:Acronym
Effects of Nurses' Eye Contact on Autonomic Nervous System Activity and Subjective Impressions in Participants
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the impact of nurses' eye contact on recipients' autonomic nervous activity and subjective impressions, in order to evaluate the effectiveness of eye contact.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability (HRV) parameters, including RRI, HF, LF/HF, CVI, and CSI, were measured at three time points for each intervention: during the resting phase before the intervention, during the intervention itself, and during the resting phase after the intervention.
Subjective impression evaluations (using semantic differential scales and adjective pairs) are measured before and after the experiment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
| Maneuver |
Interventions/Control_1
Interact in communication settings with frequent use of eye contact.
Interventions/Control_2
Interact in communication settings with minimal use of eye contact.
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
Individuals who are not taking any medications and have no cardiovascular, psychiatric, or underlying chronic diseases.
Individuals who can refrain from consuming alcohol from the day before the experiment.
Individuals who can get sufficient sleep and rest from the day before the experiment.
Individuals who can refrain from eating for two hours prior to the experiment (drinking water is allowed).
Individuals who can avoid strenuous exercise immediately before the experiment.
Key exclusion criteria
Individuals who do not meet even one of the inclusion criteria.
Individuals who do not provide informed consent to participate in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Aoto |
| Middle name | |
| Last name | Nishiguchi |
Organization
Kitasato University Graduate School of Nursing
Division name
Practical and Educational Nursing Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
090-9006-0755
saotori@docomo.ne.jp
Public contact
Name of contact person
| 1st name | Aoto |
| Middle name | |
| Last name | Nishiguchi |
Organization
Kitasato University Graduate School of Nursing
Division name
Practical and Educational Nursing Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
09090060755
Homepage URL
saotori@docomo.ne.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
Research Ethics Review Committee, School of Nursing, Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
Tel
042-778-9243
hrp1@kitasato-u.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 | 07 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066685
