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

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03375931
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
28.5
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prayer
  • Behavioral: non-prayer
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective Randomized open studyProspective 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 :
Dec 15, 2017
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. QoR40 on POD1 [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

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT03375931
Other Study ID Numbers:
  • 4-2017-0251
First Posted:
Dec 18, 2017
Last Update Posted:
Jan 11, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Thyroid Neoplasms

Study Results

No Results Posted as of Jan 11, 2019