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 |
Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Exploratory research to investigate parameters reflecting stressor-induced autonomic alteration.
Japan |
Diseases in otolaryngology and head and neck
Oto-rhino-laryngology |
Others
NO
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.
Efficacy
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
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
Observational
18 | years-old | <= |
90 | years-old | > |
Male and Female
Patients underwent otolaryngology Head and Neck surgery
genetic disorder, severe respiratory disease, 100 percent pacemaker dependency, central nervous system disease, analgesic common use for chronic pain, malignant tumors in otolaryngology field
800
1st name | |
Middle name | |
Last name | Masaaki Ishikawa |
Hyogo Prefectural Amagasaki General Medical Center
Department of otolaryngology and head and neck
Hyogo prefecture amagasaki city higashinannbacho 2 17-77
06-6480-7000
m_ishikawa@ent.kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Masaaki Ishikawa |
Hyogo Prefectural Amagasaki General Medical Center
Department of otolaryngology and head and neck
Hyogo prefecture amagasaki city higashinannbacho 2 17-77
06-6480-7000
m_ishikawa@ent.kuhp.kyoto-u.ac.jp
Hyogo Prefectural Amagasaki General Medical Center
Nothing
Other
NO
2019 | Year | 01 | Month | 05 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 01 | Month | 05 | Day |
2019 | Year | 01 | Month | 06 | Day |
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
2019 | Year | 01 | Month | 05 | Day |
2019 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040392