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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035452
Receipt No. R000040392
Scientific Title Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/05

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Basic information
Public title Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Acronym Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Scientific Title Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Scientific Title:Acronym Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Region
Japan

Condition
Condition Diseases in otolaryngology and head and neck
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the autonomic alteration due to surgical invasiveness-induced physiological and psychological burden on pupil light reflex and heart rate variability, and explore the parameters reflecting the extent of burden and confounding factors affecting the parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Parameter alteration obtained from pupil light reflex and heart rate variability among 3 terms.
1. 1 day before surgery
2. Just before surgery
3. 1 day after surgery
Key secondary outcomes Alteration of parameter correlation between pupil light reflex and heart rate variability among 3 terms.
1. 1 day before surgery
2. Just before surgery
3. 1 day after surgery

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients underwent otolaryngology Head and Neck surgery
Key exclusion criteria genetic disorder, severe respiratory disease, 100 percent pacemaker dependency, central nervous system disease, analgesic common use for chronic pain, malignant tumors in otolaryngology field
Target sample size 800

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masaaki Ishikawa
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of otolaryngology and head and neck
Zip code
Address Hyogo prefecture amagasaki city higashinannbacho 2 17-77
TEL 06-6480-7000
Email m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masaaki Ishikawa
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of otolaryngology and head and neck
Zip code
Address Hyogo prefecture amagasaki city higashinannbacho 2 17-77
TEL 06-6480-7000
Homepage URL
Email m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Nothing
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
Address
Tel
Email

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
2019 Year 01 Month 05 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study(Prospective cohort study)
To explore the parameters obtained from pupil light reflex and heart rate variability for reflecting the extent of the phycological and psychological burden due to surgical invasiveness by evaluating the burden subjectively and objectively.
Subjective evaluation: Numerical rating scale for pain intensity, POMS and STAI for mood alteration
Objective evaluation: Heart rate variability and pupil light reflex(4 different stimulus intensities)
3 assessment points: 1 day before surgery, just before surgery, and 1 day after surgery

Included criteria: Patients underwent in 5 representative otolaryngology head and neck surgery in the followings: tympanoplasty, endoscopic nasal and sinus surgery, endoscopic transoral surgery, tonsillectomy, laryngomicrosurgery, neck benign tumor surgery

Confounding factors: age, sex, BMI, social life such as smoking and drinking, menstrual status, surgical procedure type, stimulus intensities of pupil light reflex

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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