NCT05388799

Brief Summary

The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. The sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.The data of the study were collected by using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale, which were prepared in line with the literature.The data will be analyzed with the SPSS package program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 17, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

May 17, 2022

Last Update Submit

August 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The effect of preoperative care on surgical fear in patients scheduled for nasal surgery

    It will be evaluated with the 8-item Surgical Fear Scale, which was adapted into Turkish by Bağdigen and Karaman Özlü in 2016.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery.The score obtained from the items of the scale ranges from 0 to 10 (0 "I am not afraid at all", 10 "I am very afraid").The lowest score that can be obtained from the scale is 0, while the highest score is 80.The higher the score, the higher the patient's fear of surgery.

    six months

  • The effect of preoperative care on surgical anxiety in patients scheduled for nasal surgery

    It will be evaluated with the 17-item Surgical Anxiety Scale adapted into Turkish by Göl and Bölükbaş.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery. The scale is in a five-point Likert type, scored as "never-0", "very little-1", "moderately-2", "very-3" and "extremely-4". The lowest score that can be obtained from the scale is 0, and the highest score is 68, and the higher the score, the higher the level of surgical anxiety.

    six months

Study Arms (2)

application group

EXPERIMENTAL

Before the operation, training will be given in line with the training brochure prepared by the researcher in the outpatient clinic and the printed version of the training brochure will be given to the patient. The training will be repeated by calling the patients the day before the surgery.

Other: Educational intervention

control group

NO INTERVENTION

Standard care will be applied.

Interventions

In addition to standard care, brochure-supported education will be given to patients who are scheduled for nose surgery.

application group

Eligibility Criteria

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

You may qualify if:

  • years and over, 65 years and under,
  • Being literate,
  • To be able to understand and speak Turkish
  • First time nose surgery,
  • Agreeing to participate in the research.

You may not qualify if:

  • Having any psychiatric disorder that may reduce the ability to comprehend and understand
  • The surgery was canceled for some reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University Institute of Health Sciences

Hatay, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer Dr.

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 24, 2022

Study Start

August 1, 2022

Primary Completion

September 1, 2022

Study Completion

February 1, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations