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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03861104
Other study ID # KA18/390
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2019
Est. completion date July 30, 2019

Study information

Verified date May 2019
Source Baskent University
Contact Pelin Kocdor, MD
Phone +905324722529
Email pelinkocdor@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- patients who will undergo septoplasty/septorhinoplasty procedures

- patients who will receive nasal packing at their septoplasty septorhinoplasty procedures

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
medical educational video
information based on visual and auditory communication

Locations

Country Name City State
Turkey Baskent University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03575689 - Nasal Splint and Endoscopic Nasal Septal Repair Surgery N/A