Circadian RhythmNCT05379192
The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery
An observational study of Circadian Rhythm and Postoperative Pain, run by Faruk Cicekci at 2 sites in Turkey (Türkiye).
Trial summary
These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm, Postoperative Pain
- What is being tested?
- Group 1, Group 2, Group 3, Group 4
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patient population of both sexes aged 6-18 years
Who may be able to join
- American Society of Anesthesiologists (ASA) physical condition I-II,
- Undergoing acute appendicitis,
- Patients aged 6-18 years
Who cannot join
- ASA ≥ III,
- Uncontrolled chronic, metabolic disease,
- Opioid or analgesic use in the last 10 days,
- Acute peritonitis or sepsis
- History of abnormal operation or recovery from anesthesia,
- Patients with parents who are unwilling to give informed consent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University, School of Medicine
Konya, 42080
Selcuk University, School of Medicine
Konya, 42250
About this study
Official title: How Does Circadian Rhythm Affect Postoperative Pain After Pediatric Acute Appendicit Operation?
These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Altered circadian pain rhythms manifest inconsistently in various disease states. circadian differences exist in tolerability of administration as well as in effectiveness of analgesia during surgical, obstetric, and dental procedures, with the majority of studies demonstrating highest pain sensitivity during the overnight or early morning hours. Although the relationship between pain states and circadian rhythm has been studied in various surgical procedures and chronic pain syndromes, there is little literature examining the relationship between postoperative pain and circadian rhythm in pediatric surgical procedures. Therefore, it was aimed to evaluate the relationship between postoperative pain and circadian rhythm after pediatric acute appendicitis surgery.
Read the detailed description
This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 200 patients aged 6-18 years, after the approval of the Faculty Local Ethics Committee in the Department of Anesthesiology, Faculty of Medicine, Selcuk University. According to the time the patients were taken into the operation, Group 1; 01:01-07:00, Group 2; 07:01-13:00, Group 3; 13:01-20:00 and Group 4; 20:01-01:00, It will be divided into four groups between. The files of the patients will be examined and demographic data such as age (year), body weight (kg), height (cm), gender, ASA scores (I-III), anesthesia and surgery time, anesthesia and surgery time will be recorded. Intraoperative vital signs; systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) oxygen saturation (SpO2) Endtidal CO2 and temperature before operation (control) and 5, 10, 15, 20, 25 and 30 minutes (min) and at the end of the process (end) data will also be saved. Perioperative side effects such as nausea-vomiting, hypotension, bradycardia, tremor, respiratory distress, sore throat, headache, and dizziness symptoms will be noted if they occur. The routinely applied analgesic protocol and vital signs in the postoperative pediatric surgery service, the total amount of analgesic administered, the time to first analgesia requirement and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. There will be no interference with the routinely applied analgesic protocol.
- Conditions
- Circadian Rhythm, Postoperative Pain
- Being tested
- Group 1, Group 2, Group 3, Group 4
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1, Group 2, Group 3, Group 4Other
The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sociodemographic and clinical data of the patients who will be operated between 01:01-07:00 AM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. Receives: Other: Group 1, Group 2, Group 3, Group 4 | |
| Group 2 | Patients who were operated between 07:01-13:00. Sociodemographic and clinical data of the patients who will be operated between 07:00 AM- 01:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. Receives: Other: Group 1, Group 2, Group 3, Group 4 | |
| Group 3 | Sociodemographic and clinical data of the patients who will be operated between 01:00 - 08:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. Receives: Other: Group 1, Group 2, Group 3, Group 4 | |
| Group 4 | Sociodemographic and clinical data of the patients who will be operated between 08:00 PM -01:00 AM will be recorded. The total amount of antiemetic,the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. Receives: Other: Group 1, Group 2, Group 3, Group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative VAS pain scores
The VAS scores at 1st will be recorded.
Measured: 1st hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 2nd will be recorded.
Measured: 2nd hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 3th will be recorded.
Measured: 3th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 6th will be recorded.
Measured: 6th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 9th will be recorded.
Measured: 9th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 12th will be recorded.
Measured: 12th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 15th will be recorded.
Measured: 15th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 18th will be recorded.
Measured: 18th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 21th will be recorded.
Measured: 21th hours , postoperatively
The postoperative VAS pain scores
The VAS scores at 24th will be recorded.
Measured: 24th hours , postoperatively
Secondary outcomes (2)
The total amount of analgesic
The total amount of analgesic will be recorded postoperativly .
Measured: 24 hours, postoperatively
the time to first analgesia requirement
the time to first analgesia requirement will be recorded postoperativly .
Measured: 24 hours, postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Faruk Cicekci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Faruk Cicekci, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379192
- Sponsor's protocol ID
- farukcicekci5
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Circadian Rhythm Affect Postoperative Pain After Pediatric Acute Appendicit Operation?
- ClinicalTrials.gov ID
- NCT05379192
- Acronym / sponsor ID
- farukcicekci5
- Conditions
- Circadian Rhythm, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Faruk CicekciUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 May 2022 (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.
These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Altered circadian pain rhythms manifest inconsistently in various disease states. circadian differences exist in tolerability of administration as well as in effectiveness of analgesia during surgical, obstetric, and dental procedures, with the majority of studies demonstrating highest pain sensitivity during the overnight or early morning hours. Although the relationship between pain states and circadian rhythm has been studied in various surgical procedures and chronic pain syndromes, there is little literature examining the relationship between postoperative pain and circadian rhythm in pediatric surgical procedures. Therefore, it was aimed to evaluate the relationship between postoperative pain and circadian rhythm after pediatric acute appendicitis surgery.
Detailed description
This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 200 patients aged 6-18 years, after the approval of the Faculty Local Ethics Committee in the Department of Anesthesiology, Faculty of Medicine, Selcuk University. According to the time the patients were taken into the operation, Group 1; 01:01-07:00, Group 2; 07:01-13:00, Group 3; 13:01-20:00 and Group 4; 20:01-01:00, It will be divided into four groups between. The files of the patients will be examined and demographic data such as age (year), body weight (kg), height (cm), gender, ASA scores (I-III), anesthesia and surgery time, anesthesia and surgery time will be recorded. Intraoperative vital signs; systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) oxygen saturation (SpO2) Endtidal CO2 and temperature before operation (control) and 5, 10, 15, 20, 25 and 30 minutes (min) and at the end of the process (end) data will also be saved. Perioperative side effects such as nausea-vomiting, hypotension, bradycardia, tremor, respiratory distress, sore throat, headache, and dizziness symptoms will be noted if they occur. The routinely applied analgesic protocol and vital signs in the postoperative pediatric surgery service, the total amount of analgesic administered, the time to first analgesia requirement and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. There will be no interference with the routinely applied analgesic protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Group 1, Group 2, Group 3, Group 4Sociodemographic and clinical data of the patients who will be operated between 01:01-07:00 AM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. |
| Group 2 | – | Other: Group 1, Group 2, Group 3, Group 4Patients who were operated between 07:01-13:00. Sociodemographic and clinical data of the patients who will be operated between 07:00 AM- 01:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. |
| Group 3 | – | Other: Group 1, Group 2, Group 3, Group 4Sociodemographic and clinical data of the patients who will be operated between 01:00 - 08:00 PM will be recorded. The total amount of antiemetic, the time of first antiemetic use and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. |
| Group 4 | – | Other: Group 1, Group 2, Group 3, Group 4Sociodemographic and clinical data of the patients who will be operated between 08:00 PM -01:00 AM will be recorded. The total amount of antiemetic,the time of first antiemetic use, and the VAS scores at the postoperative 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patient population of both sexes aged 6-18 years
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical condition I-II,
- Undergoing acute appendicitis,
- Patients aged 6-18 years
Key exclusion criteria (6 listed)
- ASA ≥ III,
- Uncontrolled chronic, metabolic disease,
- Opioid or analgesic use in the last 10 days,
- Acute peritonitis or sepsis
- History of abnormal operation or recovery from anesthesia,
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 |
|---|---|---|
| Group 1, Group 2, Group 3, Group 4The total amount of antiemetic,the time of first antiemetic use and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours postoperatively will also be recorded according to circadian rhythm | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
The postoperative VAS pain scores
Time frame: 1st hours , postoperatively
The VAS scores at 1st will be recorded.
The postoperative VAS pain scores
Time frame: 2nd hours , postoperatively
The VAS scores at 2nd will be recorded.
The postoperative VAS pain scores
Time frame: 3th hours , postoperatively
The VAS scores at 3th will be recorded.
The postoperative VAS pain scores
Time frame: 6th hours , postoperatively
The VAS scores at 6th will be recorded.
The postoperative VAS pain scores
Time frame: 9th hours , postoperatively
The VAS scores at 9th will be recorded.
The postoperative VAS pain scores
Time frame: 12th hours , postoperatively
The VAS scores at 12th will be recorded.
The postoperative VAS pain scores
Time frame: 15th hours , postoperatively
The VAS scores at 15th will be recorded.
The postoperative VAS pain scores
Time frame: 18th hours , postoperatively
The VAS scores at 18th will be recorded.
The postoperative VAS pain scores
Time frame: 21th hours , postoperatively
The VAS scores at 21th will be recorded.
The postoperative VAS pain scores
Time frame: 24th hours , postoperatively
The VAS scores at 24th will be recorded.
2 secondary outcomes
The total amount of analgesic
Time frame: 24 hours, postoperatively
the time to first analgesia requirement
Time frame: 24 hours, postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No. I do not have a plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm and Postoperative Pain, run by Faruk Cicekci at 2 sites in Turkey (Türkiye).
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 6 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative VAS pain scores (time frame: 1st hours , postoperatively). The study lists 10 primary outcomes in all. 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 18 May 2022.