AnxietyNCT04923490
Anxiety Levels in Adolescents Undergoing Endoscopy
An observational study of Anxiety, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to evaluate the pre-procedure state and trait anxiety levels of adolescents patients hospitalized for the purpose of gastrointestinal endoscopy performed under sedation. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- state and trait anxiety scale levels
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Jul 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 180 pediatric patients
Who may be able to join
- Children aged 11-18 years
- ASA I-II
- cooperative
- literate
- undergoing elective endoscopic procedures
Who cannot join
- under 11 years of age
- uncooperative
- illiterate
- had known psychiatric disorders or were using psychiatric drugs
- emergency endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of State and Trait Anxiety Levels in Adolescents Undergoing Endoscopy Under Anesthesia
The aim of our study was to evaluate the pre-procedure state and trait anxiety levels of adolescents patients hospitalized for the purpose of gastrointestinal endoscopy performed under sedation.
Read the detailed description
Although anxiety is known to be a disorder that is much more relevant for adults, it is seen at a frequency of approximately 6.5% in the childhood and adolescence. Anxiety is usually examined in two different forms, state anxiety and trait anxiety. A total of 180 pediatric patients who underwent GIS endoscopy in our hospital were included in our study. Demographic data (age, gender, height, weight, educational status, school and grade), additional diseases and diagnoses were recorded. Our aim was to evaluate the anxiety and trait anxiety levels of adolescents scheduled for gastrointestinal system (GIS) endoscopy under sedation, after being admitted as a single-day inpatient and before the procedure. A form evaluating state and trait anxiety levels (Spielberger's state and trait anxiety scale) and another form consisting of demographic data were given to the patients. We requested that the forms be filled by the children themselves. After monitoring in the endoscopy unit, sedation was applied with IV anesthetic drugs routinely.Oxygenation was provided with nasal O2 in all patients. Heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2) were monitored. Also complications (bradycardia, tachycardia, arrhythmia, hypotension, hypertension, bronchospasm, decrease in SpO2, apnea) were recorded.
- Conditions
- Anxiety
- Being tested
- state and trait anxiety scale levels
- Keywords
- Adolescent, anxiety, endoscopy, anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
state and trait anxiety scale levelsBehavioural
While the STAI-I anxiety level is scored as "(1) never, (2) somewhat, (3) frequently, and (4) almost always", the scoring options in STAI-II are "(1) almost never, (2) sometimes, (3) most of the time, and (4) almost always".
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level
Score between 0-19: No anxiety Score between 20-39: Mild anxiety Score between 40-59: Moderate anxiety Score between 60-79: Severe anxiety 80 and above score: Panic level anxiety
Measured: before anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2019
- Primary completion1 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ümran Ü Karaca, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalDerya D Karasu, Assoc Prof, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalŞermin Ş Eminoğlu, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalŞeyda Efsun ŞE Özgünay, Assoc Prof, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalTuğba T Onur, MD, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923490
- Sponsor's protocol ID
- bursa hospital
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Abstract of record
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of State and Trait Anxiety Levels in Adolescents Undergoing Endoscopy Under Anesthesia
- ClinicalTrials.gov ID
- NCT04923490
- Acronym / sponsor ID
- bursa hospital
- Conditions
- Anxiety
- Keywords
- Adolescent, anxiety, endoscopy, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Jun 2021 (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 aim of our study was to evaluate the pre-procedure state and trait anxiety levels of adolescents patients hospitalized for the purpose of gastrointestinal endoscopy performed under sedation.
Detailed description
Although anxiety is known to be a disorder that is much more relevant for adults, it is seen at a frequency of approximately 6.5% in the childhood and adolescence. Anxiety is usually examined in two different forms, state anxiety and trait anxiety. A total of 180 pediatric patients who underwent GIS endoscopy in our hospital were included in our study. Demographic data (age, gender, height, weight, educational status, school and grade), additional diseases and diagnoses were recorded. Our aim was to evaluate the anxiety and trait anxiety levels of adolescents scheduled for gastrointestinal system (GIS) endoscopy under sedation, after being admitted as a single-day inpatient and before the procedure. A form evaluating state and trait anxiety levels (Spielberger's state and trait anxiety scale) and another form consisting of demographic data were given to the patients. We requested that the forms be filled by the children themselves. After monitoring in the endoscopy unit, sedation was applied with IV anesthetic drugs routinely.Oxygenation was provided with nasal O2 in all patients. Heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2) were monitored. Also complications (bradycardia, tachycardia, arrhythmia, hypotension, hypertension, bronchospasm, decrease in SpO2, apnea) were recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 180 pediatric patients
Key inclusion criteria (5 listed)
- Children aged 11-18 years
- ASA I-II
- cooperative
- literate
- undergoing elective endoscopic procedures
Key exclusion criteria (5 listed)
- under 11 years of age
- uncooperative
- illiterate
- had known psychiatric disorders or were using psychiatric drugs
- emergency endoscopy
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 |
|---|---|---|
| state and trait anxiety scale levelsWhile the STAI-I anxiety level is scored as "(1) never, (2) somewhat, (3) frequently, and (4) almost always", the scoring options in STAI-II are "(1) almost never, (2) sometimes, (3) most of the time, and (4) almost always". | Behavioural | – |
Primary outcome
anxiety level
Time frame: before anesthesia induction
Score between 0-19: No anxiety Score between 20-39: Mild anxiety Score between 40-59: Moderate anxiety Score between 60-79: Severe anxiety 80 and above score: Panic level anxiety
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 11 Jun 2021.
- Individual participant dataSharing planned: No. Abstract of record
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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.
Ümran Ü Karaca, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Derya D Karasu, Assoc Prof study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Şermin Ş Eminoğlu, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
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 Anxiety, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 5 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 11 Jun 2021. 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?
anxiety level (time frame: before anesthesia induction). 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 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.