Could Medical Educational Video Reduce Anxiety Before Nasal Packing Removal After Septoplasty/Septorhinoplasty?

May 29, 2019 updated by: Pelin Koçdor, Baskent University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group watched video

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.
Other: medical educational video
information based on visual and auditory communication
No Intervention: group without video
patients will fill out the spielberger state anxiety inventory without watching the video at the time of nasal packing removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2019

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

July 30, 2019

Study Registration Dates

First Submitted

February 24, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA18/390

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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