NCT03861104

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

February 24, 2019

Last Update Submit

May 29, 2019

Conditions

Keywords

septoplasty; nasal packing; anxiety; medical video

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 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.

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

Interventions

information based on visual and auditory communication

group watched video

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Pelin Kocdor, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: one group will watch informative video and the control group will not before nasal packing removal
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

Locations