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

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ClinicalTrials.gov Identifier: NCT03375931
Recruitment Status : Unknown
Verified January 2019 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : December 18, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Thyroid Cancer Behavioral: Prayer Behavioral: non-prayer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized open study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: prayer group Behavioral: Prayer
If the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia.
Active Comparator: non-prayer group Behavioral: non-prayer
If the patient does not want to pray, the anesthesiologist does anesthesia without praying.


Outcome Measures
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Primary Outcome Measures :
  1. QoR40 on POD1 [ Time Frame: within the first 1 day after surgery ]
    On the first day after surgery, visit the patient and give the QoR 40 to the patient to fill out a questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375931


Contacts
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Contact: Sun Joon Bai, MD 82-2-2228-4438 sjbae@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sun Joon Bai, MD    82-2-2228-4438    sjbae@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03375931    
Other Study ID Numbers: 4-2017-0251
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Quality of Recovery 40 Questionaries
Additional relevant MeSH terms:
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Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases