Septum DeviatedNCT03861104
Could Medical Educational Video Reduce Anxiety Before Nasal Packing Removal After Septoplasty/Septorhinoplasty?
A study testing medical educational video in people with Septum Deviated and Septoplasty/Septorhinoplasty, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Septoplasty/septorhinoplasty is one of the most common surgical procedures performed in ENT clinics. Intranasal packing is widely used post-operatively for nasal septum stabilization and bleeding control. Patients experience pain after septoplasty during the removal of nasal packing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Septum Deviated, Septoplasty/Septorhinoplasty
- What is being tested?
- medical educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2019to 30 Jul 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who will undergo septoplasty/septorhinoplasty procedures
- patients who will receive nasal packing at their septoplasty septorhinoplasty procedures
Who cannot join
- patients who will not want to participate to the study
- revision surgeries
- if the patient is taking antidepressants during the last 6 months
- if the patient has a history of a disease that can affect anxiety levels
- if patient wants to be excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Hospital
Istanbul, 34662
5324722529, pelinkocdor@gmail.com
About this study
Official title: Medikal eğitim Videosu, Septoplasti/Septorinoplasti sonrası Nazal Tampon çekiminde Anksiyetiyi Azaltabilir mi?
Septoplasty/septorhinoplasty is one of the most common surgical procedures performed in ENT clinics. Intranasal packing is widely used post-operatively for nasal septum stabilization and bleeding control. Patients experience pain after septoplasty during the removal of nasal packing. These patients may be concerned about pain before nasal packing removal, thus increasing anxiety levels. Various methods are currently employed to reduce this pain. Anxiety is a symptom when a person does not feel safe. Anxiety levels can be objectively measured using different tests including Spielberger state anxiety inventory.
In this digital era, there is a growing tendency to use the popular internet sites as YouTube, Google as a new electronic learning for medical information. The quality of information found on YouTube or other sources could be low and make people more anxious before a minor procedure.
Investigators aim to evaluate the effect of visual and auditory information prepared by the surgeon on anxiety level of patient at nasal packing removal after septoplasty/septorhinoplasty. For this purpose; patients who will undergo septo and septorhinoplasty at Istanbul Baskent University Hospital are recruited. A video of nasal packing removal performed by the surgeon will be watched by the patient and Spielberger state anxiety inventory will be filled out before nasal packing removal. The control group will fill out Spielberger State Anxiety Inventory without watching the video before nasal packing removal. The scores of the groups will be compared and the effect of the video based information on anxiety will be revealed.
- Conditions
- Septum Deviated, Septoplasty/Septorhinoplasty
- Being tested
- medical educational video
- Keywords
- septoplasty; nasal packing; anxiety; medical video
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical educational videoOther
information based on visual and auditory communication
| Study group | Role | What they receive |
|---|---|---|
| group watched video | Active comparator | patients will watch the medical video before filling out the spielberger state anxiety inventory at the time of nasal packing removal.
intervention is watching informative video. Receives: Other: medical educational video |
| group without video | No intervention | patients will fill out the spielberger state anxiety inventory without watching the video at the time of nasal packing removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of visual and auditory information on anxiety levels by using spielberg state anxiety inventory
The effect of visual and auditory information prepared by the surgeon on anxiety levels at nasal packing removal after septoplasty/septorhinoplasty procedures. Mean score of the inventory is 36-41. The minimum and maximum scores of the inventory are 20 and 80. High score means high anxiety level and low score means low anxiety level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start30 May 2019
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septum DeviatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group will watch informative video and the control group will not before nasal packing removal
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Koçdor, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861104
- Sponsor's protocol ID
- KA18/390
- Status last verified
- May 2019
- First submitted
- 24 Feb 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medikal eğitim Videosu, Septoplasti/Septorinoplasti sonrası Nazal Tampon çekiminde Anksiyetiyi Azaltabilir mi?
- ClinicalTrials.gov ID
- NCT03861104
- Acronym / sponsor ID
- KA18/390
- Conditions
- Septum Deviated, Septoplasty/Septorhinoplasty
- Keywords
- septoplasty; nasal packing; anxiety; medical video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 4 Mar 2019 (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.
Septoplasty/septorhinoplasty is one of the most common surgical procedures performed in ENT clinics. Intranasal packing is widely used post-operatively for nasal septum stabilization and bleeding control. Patients experience pain after septoplasty during the removal of nasal packing. These patients may be concerned about pain before nasal packing removal, thus increasing anxiety levels. Various methods are currently employed to reduce this pain. Anxiety is a symptom when a person does not feel safe. Anxiety levels can be objectively measured using different tests including Spielberger state anxiety inventory.
In this digital era, there is a growing tendency to use the popular internet sites as YouTube, Google as a new electronic learning for medical information. The quality of information found on YouTube or other sources could be low and make people more anxious before a minor procedure.
Investigators aim to evaluate the effect of visual and auditory information prepared by the surgeon on anxiety level of patient at nasal packing removal after septoplasty/septorhinoplasty. For this purpose; patients who will undergo septo and septorhinoplasty at Istanbul Baskent University Hospital are recruited. A video of nasal packing removal performed by the surgeon will be watched by the patient and Spielberger state anxiety inventory will be filled out before nasal packing removal. The control group will fill out Spielberger State Anxiety Inventory without watching the video before nasal packing removal. The scores of the groups will be compared and the effect of the video based information on anxiety will be revealed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group will watch informative video and the control group will not before nasal packing removal
| Arm | Type | Receives |
|---|---|---|
| group watched video | Active comparator | Other: medical educational videopatients will watch the medical video before filling out the spielberger state anxiety inventory at the time of nasal packing removal. intervention is watching informative video. |
| group without video | No intervention | –patients will fill out the spielberger state anxiety inventory without watching the video at the time of nasal packing removal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who will undergo septoplasty/septorhinoplasty procedures
- patients who will receive nasal packing at their septoplasty septorhinoplasty procedures
Key exclusion criteria (5 listed)
- patients who will not want to participate to the study
- revision surgeries
- if the patient is taking antidepressants during the last 6 months
- if the patient has a history of a disease that can affect anxiety levels
- if patient wants to be excluded from the study
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 |
|---|---|---|
| medical educational videoinformation based on visual and auditory communication | Other | group watched video |
Primary outcome
The effect of visual and auditory information on anxiety levels by using spielberg state anxiety inventory
Time frame: 1 year
The effect of visual and auditory information prepared by the surgeon on anxiety levels at nasal packing removal after septoplasty/septorhinoplasty procedures. Mean score of the inventory is 36-41. The minimum and maximum scores of the inventory are 20 and 80. High score means high anxiety level and low score means low anxiety level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical educational video in people with Septum Deviated and Septoplasty/Septorhinoplasty, run by Baskent 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 2 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pelin Kocdor, MD (+905324722529, pelinkocdor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of visual and auditory information on anxiety levels by using spielberg state anxiety inventory (time frame: 1 year). 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 30 May 2019.