AnesthesiaNCT07077200
Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Preoperative Anxiety
An observational study of Anesthesia and Sedation, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to compare the effects of short video viewing and intranasal dexmedetomidine administration-both of which are part of routine clinical practices in the pediatric endoscopy unit-on preoperative anxiety levels and the need for intravenous sedation. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Anesthesia, Sedation, Anxiety
- What is being tested?
- Intranasal dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 10 Oct 2025
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The study included patients aged 2-12 years, classified as ASA I-II, who were scheduled to undergo endoscopy and/or colonoscopy by a pediatric gastroenterologist based on a clinical indication
Who may be able to join
- Patients aged 2-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II
Who cannot join
- Patients under 2, over 12, or with ASA score >2
- Epilepsy
- Cardiovascular diseases
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Management of Preoperative Anxiety and Sedation in Pediatric Endoscopy
This observational study aims to compare the effects of short video viewing and intranasal dexmedetomidine administration-both of which are part of routine clinical practices in the pediatric endoscopy unit-on preoperative anxiety levels and the need for intravenous sedation. Patients who are exposed to these interventions as part of routine clinical care will be included in the study.
Read the detailed description
Pediatric patients scheduled for upper or lower gastrointestinal endoscopy in the hospital's endoscopy unit and who receive either short video viewing or intranasal dexmedetomidine as part of standard clinical practice will be included in this study. The primary objective is to compare these two modalities in terms of preoperative anxiety, requirement for sedative agents, difficulty of intravenous access, and levels of satisfaction reported by parents and endoscopists.
This study will be conducted with a prospective and observational design. Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:
T1: Upon arrival in the preoperative holding area, T2: Prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction. The consumption of sedative agents (e.g., propofol) will be recorded in terms of total dosage (mg) and dosage per kilogram of body weight (mg/kg). The difficulty of intravenous access will be rated on a 5-point scale. Parental satisfaction will be assessed using the PedsQL Healthcare Satisfaction Scale, while endoscopist satisfaction will be evaluated using a 5-point Likert scale. Statistical analyses will be performed to compare the outcomes between the two study groups.
Short Video Viewing Group:
All patients will be brought to the preoperative preparation area. Anxiety assessments using the mYPAS will be conducted at the designated time points. Patients will be allowed to watch short videos (such as YouTube Shorts, TikTok, Instagram Shorts, or cartoons), selected based on their preferences and filtered for age-appropriateness. Patients who refuse to watch the videos or encounter technical difficulties will be excluded from the study.
Intranasal Dexmedetomidine Group:
Patients in this group will receive intranasal dexmedetomidine via a mucosal atomiser device at a dose of 3 mcg/kg upon arrival at the preoperative holding area. mYPAS assessments will be carried out at the same three time points.
- Conditions
- Anesthesia, Sedation, Anxiety
- Being tested
- Intranasal dexmedetomidine
- Keywords
- Intranasal dexmedetomidine, Non-operating room anesthesia, Preoperative anxiety, Pediatric endoscopy, Short video viewing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineOther
This intervention is distinguished by the use of intranasal dexmedetomidine at a standardized dose of 3 mcg/kg, administered non-invasively upon the child's arrival in the preoperative holding area. Unlike other pharmacological methods that often require intravenous access or oral administration, this approach minimizes procedural stress and discomfort, which is particularly advantageous in pediatric populations.
Dexmedetomidine is a selective alpha-2 adrenergic agonist known for its anxiolytic, sedative, and analgesic properties, without causing significant respiratory depression-a key concern with agents like benzodiazepines or opioids. Its intranasal delivery provides a rapid onset of action while maintaining hemodynamic stability, which is critical during the preoperative period.
This intervention is also notable for its comparison with a non-pharmacological strategy-short video viewing-making the study unique in evaluating the relative efficacy of a low-risk pharmacologic option
| Study group | Role | What they receive |
|---|---|---|
| İntranasal Dexmedetomidine | Patients will be admitted to the preoperative holding area prior to the procedure. Upon arrival, intranasal dexmedetomidine will be administered at a dose of 3 mcg/kg via a mucosal atomiser device. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at three time intervals: upon arrival in the procedure room, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia (induction). Receives: Other: Intranasal dexmedetomidine | |
| Short videos | Patients will be admitted to the preoperative holding area prior to the procedure. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at the following time points: upon arrival in the holding area, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia. In the waiting area, children will be allowed to watch short videos on a platform of their choice (e.g., YouTube Shorts, TikTok, Instagram Shorts, cartoons, etc.) using the phone or tablet they typically use at home with their families. All content will be filtered for child-appropriate material. Children who refuse to watch or encounter technical issues during the video session will be excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:
T1: upon arrival in the preoperative holding area, T2: prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction.
Measured: 1hour
Secondary outcomes (4)
Recovery Time
The duration of patient monitoring in the recovery unit continued until a Modified Aldrete Score of 9 or higher was achieved.
Measured: 1 hour
Sedation Scores
Sedation levels assessed using the Ramsay Sedation Scale (RSS) in the preoperative preparation unit, procedure room, and recovery unit constituted the secondary outcome of the study.
Measured: 2 hour
The difficulty level of intravenous (IV) access
"The difficulty level of intravenous (IV) access was assessed using a 5-point Likert scale.
Measured: 1 hour
Endoscopist satisfaction
Endoscopist satisfaction was evaluated with a 5-point Likert scale.
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jul 2025
- Primary completion3 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caner genc, Samsun University
- Investigators
- Caner Genc, M.D., Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077200
- Sponsor's protocol ID
- Intranasal Dex Vs Short Videos
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.
PubMed 40319232
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intranasal Dexmedetomidine and Short Video Viewing in the Management of Preoperative Anxiety and Sedation in Pediatric Endoscopy
- ClinicalTrials.gov ID
- NCT07077200
- Acronym / sponsor ID
- Intranasal Dex Vs Short Videos
- Conditions
- Anesthesia, Sedation, Anxiety
- Keywords
- Intranasal dexmedetomidine, Non-operating room anesthesia, Preoperative anxiety, Pediatric endoscopy, Short video viewing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This observational study aims to compare the effects of short video viewing and intranasal dexmedetomidine administration-both of which are part of routine clinical practices in the pediatric endoscopy unit-on preoperative anxiety levels and the need for intravenous sedation. Patients who are exposed to these interventions as part of routine clinical care will be included in the study.
Detailed description
Pediatric patients scheduled for upper or lower gastrointestinal endoscopy in the hospital's endoscopy unit and who receive either short video viewing or intranasal dexmedetomidine as part of standard clinical practice will be included in this study. The primary objective is to compare these two modalities in terms of preoperative anxiety, requirement for sedative agents, difficulty of intravenous access, and levels of satisfaction reported by parents and endoscopists.
This study will be conducted with a prospective and observational design. Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points:
T1: Upon arrival in the preoperative holding area, T2: Prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction. The consumption of sedative agents (e.g., propofol) will be recorded in terms of total dosage (mg) and dosage per kilogram of body weight (mg/kg). The difficulty of intravenous access will be rated on a 5-point scale. Parental satisfaction will be assessed using the PedsQL Healthcare Satisfaction Scale, while endoscopist satisfaction will be evaluated using a 5-point Likert scale. Statistical analyses will be performed to compare the outcomes between the two study groups.
Short Video Viewing Group:
All patients will be brought to the preoperative preparation area. Anxiety assessments using the mYPAS will be conducted at the designated time points. Patients will be allowed to watch short videos (such as YouTube Shorts, TikTok, Instagram Shorts, or cartoons), selected based on their preferences and filtered for age-appropriateness. Patients who refuse to watch the videos or encounter technical difficulties will be excluded from the study.
Intranasal Dexmedetomidine Group:
Patients in this group will receive intranasal dexmedetomidine via a mucosal atomiser device at a dose of 3 mcg/kg upon arrival at the preoperative holding area. mYPAS assessments will be carried out at the same three time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntranasal Dexmedetomidine | – | Other: Intranasal dexmedetomidinePatients will be admitted to the preoperative holding area prior to the procedure. Upon arrival, intranasal dexmedetomidine will be administered at a dose of 3 mcg/kg via a mucosal atomiser device. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at three time intervals: upon arrival in the procedure room, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia (induction). |
| Short videos | – | –Patients will be admitted to the preoperative holding area prior to the procedure. The Modified Yale Preoperative Anxiety Scale (mYPAS) will be used to assess anxiety levels at the following time points: upon arrival in the holding area, immediately before transfer to the procedure room, and at the initiation of sedoanalgesia. In the waiting area, children will be allowed to watch short videos on a platform of their choice (e.g., YouTube Shorts, TikTok, Instagram Shorts, cartoons, etc.) using the phone or tablet they typically use at home with their families. All content will be filtered for child-appropriate material. Children who refuse to watch or encounter technical issues during the video session will be excluded from the study. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study included patients aged 2-12 years, classified as ASA I-II, who were scheduled to undergo endoscopy and/or colonoscopy by a pediatric gastroenterologist based on a clinical indication
Key inclusion criteria (1 listed)
- Patients aged 2-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II
Key exclusion criteria (4 listed)
- Patients under 2, over 12, or with ASA score >2
- Epilepsy
- Cardiovascular diseases
- Refuse to participate
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 |
|---|---|---|
| Intranasal dexmedetomidineThis intervention is distinguished by the use of intranasal dexmedetomidine at a standardized dose of 3 mcg/kg, administered non-invasively upon the child's arrival in the preoperative holding area. Unlike other pharmacological methods that often require intravenous access or oral administration, this approach minimizes procedural stress and discomfort, which is particularly advantageous in pediatric populations. Dexmedetomidine is a selective alpha-2 adrenergic agonist known for its anxiolytic, sedative, and analgesic properties, without causing significant respiratory depression-a key concern with agents like benzodiazepines or opioids. Its intranasal delivery provides a rapid onset of action while maintaining hemodynamic stability, which is critical during the preoperative period. This intervention is also notable for its comparison with a non-pharmacological strategy-short video viewing-making the study unique in evaluating the relative efficacy of a low-risk pharmacologic option | Other | İntranasal Dexmedetomidine |
Primary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
Time frame: 1hour
Preoperative anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at three distinct time points: T1: upon arrival in the preoperative holding area, T2: prior to transfer to the endoscopy suite, T3: immediately before anesthesia induction.
4 secondary outcomes
Recovery Time
Time frame: 1 hour
Sedation Scores
Time frame: 2 hour
The difficulty level of intravenous (IV) access
Time frame: 1 hour
Endoscopist satisfaction
Time frame: 2 hour
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 24 Nov 2025.
- Background: PubMed 40319232Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.
- 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.
Caner Genc, M.D. principal investigator
Samsun University
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 Anesthesia and Sedation, run by Samsun 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 1 inclusion and 4 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 24 Nov 2025. 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?
Modified Yale Preoperative Anxiety Scale (mYPAS) scores (time frame: 1hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077200, which also lists 1 linked publication.
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 24 Nov 2025.