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The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy

Primary Purpose

Thyroid Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prayer
non-prayer
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Cancer focused on measuring Quality of Recovery 40 Questionaries

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prayer group

non-prayer group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2017
Last Updated
January 10, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03375931
Brief Title
The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy
Official Title
The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Quality of Recovery 40 Questionaries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized open study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prayer group
Arm Type
Experimental
Arm Title
non-prayer group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Prayer
Intervention Description
If the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia.
Intervention Type
Behavioral
Intervention Name(s)
non-prayer
Intervention Description
If the patient does not want to pray, the anesthesiologist does anesthesia without praying.
Primary Outcome Measure Information:
Title
QoR40 on POD1
Description
On the first day after surgery, visit the patient and give the QoR 40 to the patient to fill out a questionnaire.
Time Frame
within the first 1 day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Joon Bai, MD
Phone
82-2-2228-4438
Email
sjbae@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Joon Bai, MD
Phone
82-2-2228-4438
Email
sjbae@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy

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