NCT03375931

Brief Summary

physiological end-point, incidence of adverse events, and changes in psychological status. In the past, physiological goals, major morbidity and mortality were used as indicators of recovery after surgery. However, major morbidity and mortality rates were extremely low due to the development of surgery and anesthesia techniques, and measurements of these indicators do not adequately reflect postoperative recovery. On the other hand, the measurement of the patient's health status or quality of life has become an important metric in many clinical studies. The Quality of Recovery 40 Questionnaire (QoR-40) is a multidimensional tool that specifically assesses and develops anesthetic and postoperative health conditions. Severance Hospital is conducting an anesthesiologist-led prayer for the patient only for the desired patient before anesthesia. Although it may be expected that this preoperative airway may improve the quality of recovery after anesthesia / surgery by reducing patient anxiety, there is no objective study on this. The aim of this study was to investigate the effect of preoperative preoperative airway on the quality of postoperative recovery in patients who underwent thyroidectomy for thyroid cancer. I want to see. In addition, we will investigate whether preoperative airway affects sympathetic nervous system during surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

December 5, 2017

Last Update Submit

January 10, 2019

Conditions

Keywords

Quality of Recovery 40 Questionaries

Outcome Measures

Primary Outcomes (1)

  • QoR40 on POD1

    On the first day after surgery, visit the patient and give the QoR 40 to the patient to fill out a questionnaire.

    within the first 1 day after surgery

Study Arms (2)

prayer group

EXPERIMENTAL
Behavioral: Prayer

non-prayer group

ACTIVE COMPARATOR
Behavioral: non-prayer

Interventions

PrayerBEHAVIORAL

If the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia.

prayer group
non-prayerBEHAVIORAL

If the patient does not want to pray, the anesthesiologist does anesthesia without praying.

non-prayer group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients between 20 and 70 years old under ASA 3.
  • obtaining written informed consent from the patients who were undergoing thyroidectomy.
  • weights under 90 kg and BMI under 30

You may not qualify if:

  • emergency operation
  • re-operation
  • combined surgery over 4 departments
  • cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
  • Ventricular conduction abnormality
  • prior pacemaker insertion
  • uncontrolled hypertension (diastolic blood pressure \> 110mmHg)
  • bradycardia (HR \< 40 Bpm)
  • cerebral vascular disease (cerebral hemorrhage, cerebral ischemia)
  • hepatic or renal failure
  • patients who take antiarrythmic agent
  • neurological or psychiatric illnesses
  • foreigner and patient who can not read the letter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Faith Healing

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Sun Joon Bai, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective Randomized open study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 18, 2017

Study Start

December 15, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations