UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035452 |
|---|---|
| Receipt number | 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 12:56:25 |
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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
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
m_ishikawa@ent.kuhp.kyoto-u.ac.jp
Public contact
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
m_ishikawa@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040392
