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

Sponsor
Baskent University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03861104
Collaborator
(none)
52
1
2
2
25.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: medical educational video
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one group will watch informative video and the control group will not before nasal packing removalone group will watch informative video and the control group will not before nasal packing removal
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Medikal eğitim Videosu, Septoplasti/Septorinoplasti sonrası Nazal Tampon çekiminde Anksiyetiyi Azaltabilir mi?
Actual Study Start Date :
May 30, 2019
Anticipated Primary Completion Date :
Jun 30, 2019
Anticipated Study Completion Date :
Jul 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The effect of visual and auditory information on anxiety levels by using spielberg state anxiety inventory [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baskent University Hospital Istanbul Turkey 34662

Sponsors and Collaborators

  • Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pelin Koçdor, Principal Investigator, Baskent University
ClinicalTrials.gov Identifier:
NCT03861104
Other Study ID Numbers:
  • KA18/390
First Posted:
Mar 4, 2019
Last Update Posted:
May 30, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pelin Koçdor, Principal Investigator, Baskent University

Study Results

No Results Posted as of May 30, 2019