Preoperative AnxietyNCT05802082
Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
An observational study of Preoperative Anxiety and Postoperative Delirium, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Preoperative Anxiety, Postoperative Delirium
- What is being tested?
- The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Oct 2020
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 64
Who may be able to join
- 2-10 years old,
- ASA I-II risk group
- Those who will be operated under general anesthesia under elective conditions.
- Will undergo surgery for adenoidectomy and/or tonsillectomy
- Patients whose informed consent form was read to their parents and their consent was obtained
Who cannot join
- Those whose families do not want to participate in the study,
- ASA III -IV-V patients
- Having a history of drug allergy and drug interaction,
- Having a history of systemic disease such as heart, kidney, liver failure,
- Having a history of bleeding diathesis,
- Difficult intubation expected,
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- Obese,
- Emergency patients,
- Mental-motor retarded,
- Having psychiatric and neurological diseases,
- Those with chronic drug use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: The Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.
Read the detailed description
It is known that the frequency of postoperative delirium increases in children with preoperative anxiety.
The Modified Yale Preoperative Anxiety Inventory (m-YPAS) was developed as a tool to assess children's preoperative anxiety, and m-YPAS≥30 was considered 'anxious'.
Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.
There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Being tested
- The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Modified Yale Preoperative Anxiety Scale (m-YPAS) of childrenOther
Also called Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes., The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.
Postoperative 0,5,10,15,30,45,60.and 120 minutes , PAED and WBYAS values
| Study group | Role | What they receive |
|---|---|---|
| Group P: n: 32patients | Group P: Patients administered iv 10mg/kg paracetamol 30 minutes before surgery Receives: Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children | |
| Group K:n:32 patients | Group K: Patients administered iv 10mg/kg paracetamol 15 minutes before the end of surgery Receives: Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values
Measured: During the first 2 hours postoperatively
Preemptive analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values
Measured: During the first 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Küçükosman, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802082
- Sponsor's protocol ID
- 2019/10
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
- ClinicalTrials.gov ID
- NCT05802082
- Acronym / sponsor ID
- 2019/10
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 Apr 2023 (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.
The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.
Detailed description
It is known that the frequency of postoperative delirium increases in children with preoperative anxiety.
The Modified Yale Preoperative Anxiety Inventory (m-YPAS) was developed as a tool to assess children's preoperative anxiety, and m-YPAS≥30 was considered 'anxious'.
Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes.
There are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P: n: 32patients | – | Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of childrenGroup P: Patients administered iv 10mg/kg paracetamol 30 minutes before surgery |
| Group K:n:32 patients | – | Other: The Modified Yale Preoperative Anxiety Scale (m-YPAS) of childrenGroup K: Patients administered iv 10mg/kg paracetamol 15 minutes before the end of surgery |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 64
Key inclusion criteria (5 listed)
- 2-10 years old,
- ASA I-II risk group
- Those who will be operated under general anesthesia under elective conditions.
- Will undergo surgery for adenoidectomy and/or tonsillectomy
- Patients whose informed consent form was read to their parents and their consent was obtained
Key exclusion criteria (11 listed)
- Those whose families do not want to participate in the study,
- ASA III -IV-V patients
- Having a history of drug allergy and drug interaction,
- Having a history of systemic disease such as heart, kidney, liver failure,
- Having a history of bleeding diathesis,
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 |
|---|---|---|
| The Modified Yale Preoperative Anxiety Scale (m-YPAS) of childrenAlso: Post-Anesthesia Recovery Agitation (PAED) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes., The Wong Baker Facial Pain Scale (WBYAS) is used to evaluate postoperative pain in children.Postoperative 0,5,10,15,30,45,60.and 120 minutes , PAED and WBYAS values | Other | Group K:n:32 patients, Group P: n: 32patients |
Primary outcome
Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery
Time frame: During the first 2 hours postoperatively
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values
Preemptive analgesia on Postoperative Delirium in Adenotonsillectomy Surgery
Time frame: During the first 2 hours postoperatively
The relationship between the mYPAS values of the groups and the PAED scores and Wong Baker Facial Pain Scale values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Postoperative Delirium, run by Zonguldak Bulent Ecevit University at 1 site 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 6 Apr 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preoperative Anxiety on Postoperative Delirium in Adenotonsillectomy Surgery (time frame: During the first 2 hours postoperatively). The study lists 2 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 6 Apr 2023.