Thyroid CancerNCT03375931
The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy
A study testing Prayer and non-prayer in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Prayer and non-prayer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2017to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
Sun Joon Bai, MD, 82-2-2228-4438, sjbae@yuhs.ac
About this study
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.
- Conditions
- Thyroid Cancer
- Being tested
- Prayer, non-prayer
- Keywords
- Quality of Recovery 40 Questionaries
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrayerBehavioural
If the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia.
non-prayerBehavioural
If the patient does not want to pray, the anesthesiologist does anesthesia without praying.
| Study group | Role | What they receive |
|---|---|---|
| prayer group | Experimental | Not described Receives: Behavioral: Prayer |
| non-prayer group | Active comparator | Not described Receives: Behavioral: non-prayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start15 Dec 2017
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized open study
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375931
- Sponsor's protocol ID
- 4-2017-0251
- Status last verified
- Jan 2019
- First submitted
- 5 Dec 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Prayer on Postoperative Quality of Recovery in Patients Undergoing Thyroidectomy
- ClinicalTrials.gov ID
- NCT03375931
- Acronym / sponsor ID
- 4-2017-0251
- Conditions
- Thyroid Cancer
- Keywords
- Quality of Recovery 40 Questionaries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized open study
| Arm | Type | Receives |
|---|---|---|
| prayer group | Experimental | Behavioral: Prayer |
| non-prayer group | Active comparator | Behavioral: non-prayer |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- emergency operation
- re-operation
- combined surgery over 4 departments
- cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- Ventricular conduction abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrayerIf the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia. | Behavioural | prayer group |
| non-prayerIf the patient does not want to pray, the anesthesiologist does anesthesia without praying. | Behavioural | non-prayer group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prayer and non-prayer in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Joon Bai, MD (82-2-2228-4438, sjbae@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR40 on POD1 (time frame: within the first 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.