AnesthesiaNCT06602791
The Effect of Watching Short Videos on Preoperative Anxiety
An observational study of Anesthesia and Anxiety, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Anesthesia, Anxiety
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2024to 4 Dec 2024
- How long will I take part?
- 1 Day
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II will be enrolled.
Who may be able to join
- Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II
Who cannot join
- Patients under 5, over 12, or with ASA score >2
- Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Watching Short Videos on Preoperative Anxiety in Pediatric Endoscopy Patients: A Prospective Randomized Study
Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on preoperative anxiety levels in pediatric endoscopy patients.
Read the detailed description
The study was designed as a prospective randomized trial. Patients aged 6-12 years undergoing endoscopy and/or colonoscopy in the pediatric endoscopy unit will be divided into the video and the control groups. Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone/tablet for 20 minutes under the supervision of their parents. The control group will receive standard preoperative preparation. Anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at six different time points: upon entry to the pre-procedural preparation room (T1), upon exiting the pre-procedural preparation room (T2), in the procedure room (T3), upon entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and upon exiting the recovery unit (T6). Additionally, the indication for the procedure (e.g., celiac disease, Crohn's disease, ulcerative colitis), history of prior endoscopy/colonoscopy, oxygen saturation (SPO2%), heart rate (HR), mean arterial pressure (MAP) during the procedure, and the duration of monitoring in the recovery unit will also be recorded.
- Conditions
- Anesthesia, Anxiety
- Keywords
- anesthesia, anxiety, short videos, pediatric endoscopy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Video Group | Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone or tablet for 20 minutes under the guidance of their parents. | |
| Control Group (Standard) | The control group will undergo standard preoperative preparation. Patients in this group will not watch any videos. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
Anxiety scores assessed and recorded at six distinct time points-namely, entry to the pre-procedural preparation room (T1), exit from the pre-procedural preparation room (T2), in the procedure room (T3), entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and exit from the recovery unit (T6)-constitute the primary outcome of the study.
Measured: 1 hour
Secondary outcomes (1)
Recovery Time
The duration of patient monitoring in the recovery unit post-procedure, as assessed by the Modified Aldrete Score, is designated as the secondary outcome.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion27 Nov 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
- Target duration
- 1 Day
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
- NCT06602791
- Sponsor's protocol ID
- Short videos in endoscopy
- Status last verified
- Dec 2024
- First submitted
- 17 Sep 2024
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watching Short Videos on Preoperative Anxiety in Pediatric Endoscopy Patients: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06602791
- Acronym / sponsor ID
- Short videos in endoscopy
- Conditions
- Anesthesia, Anxiety
- Keywords
- anesthesia, anxiety, short videos, pediatric endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on preoperative anxiety levels in pediatric endoscopy patients.
Detailed description
The study was designed as a prospective randomized trial. Patients aged 6-12 years undergoing endoscopy and/or colonoscopy in the pediatric endoscopy unit will be divided into the video and the control groups. Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone/tablet for 20 minutes under the supervision of their parents. The control group will receive standard preoperative preparation. Anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at six different time points: upon entry to the pre-procedural preparation room (T1), upon exiting the pre-procedural preparation room (T2), in the procedure room (T3), upon entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and upon exiting the recovery unit (T6). Additionally, the indication for the procedure (e.g., celiac disease, Crohn's disease, ulcerative colitis), history of prior endoscopy/colonoscopy, oxygen saturation (SPO2%), heart rate (HR), mean arterial pressure (MAP) during the procedure, and the duration of monitoring in the recovery unit will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Group | – | –Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone or tablet for 20 minutes under the guidance of their parents. |
| Control Group (Standard) | – | –The control group will undergo standard preoperative preparation. Patients in this group will not watch any videos. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II will be enrolled.
Key inclusion criteria (1 listed)
- Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II
Key exclusion criteria (2 listed)
- Patients under 5, over 12, or with ASA score >2
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) scores
Time frame: 1 hour
Anxiety scores assessed and recorded at six distinct time points-namely, entry to the pre-procedural preparation room (T1), exit from the pre-procedural preparation room (T2), in the procedure room (T3), entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and exit from the recovery unit (T6)-constitute the primary outcome of the study.
1 secondary outcome
Recovery Time
Time frame: 1 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 5 Dec 2024.
- 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 Anxiety, 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 2 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 5 Dec 2024. 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: 1 hour). 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 5 Dec 2024.