Could Medical Educational Video Reduce Anxiety Before Nasal Packing Removal After Septoplasty/Septorhinoplasty?
Medikal eğitim Videosu, Septoplasti/Septorinoplasti sonrası Nazal Tampon çekiminde Anksiyetiyi Azaltabilir mi?
1 other identifier
interventional
52
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2019
CompletedMay 30, 2019
May 1, 2019
1 month
February 24, 2019
May 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (2)
group watched video
ACTIVE COMPARATORpatients 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 INTERVENTIONpatients will fill out the spielberger state anxiety inventory without watching the video at the time of nasal packing removal
Interventions
information based on visual and auditory communication
Eligibility Criteria
You may qualify if:
- patients who will undergo septoplasty/septorhinoplasty procedures
- patients who will receive nasal packing at their septoplasty septorhinoplasty procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baskent University Hospital
Istanbul, 34662, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2019
First Posted
March 4, 2019
Study Start
May 30, 2019
Primary Completion
June 30, 2019
Study Completion
July 30, 2019
Last Updated
May 30, 2019
Record last verified: 2019-05