UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Title of the study (Brief title)	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
Name of lead principal investigator	Masaaki Ishikawa
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
Address	Hyogo prefecture amagasaki city higashinannbacho 2 17-77
TEL	06-6480-7000
Email	m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Masaaki Ishikawa
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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