- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771297
Education's Impact on Involuntary Thoughts and Healing in Rhinoplasty Patients
The Effect of Education Given to Patients Undergoing Rhinoplasty Surgery on Involuntary Thoughts and Recovery Quality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rhinoplasty , nose shape And function disorders elimination for the purpose of often applied surgical One is the procedure . Higher ego respect , aesthetics your concerns elimination And life of the quality increasing for the purpose of today rhinoplasty And other aesthetic surgical of procedures APPLICATION in frequency increase surgery while being observed to the process connected aspect developing anxiety because of dissatisfaction And pain like negative seeing the experiences frequency increasing . Age , personal features , history experiences And to do to applications connected aspect individual Differences by showing together hospital lying down require , general anesthesia under implementation , specific One duration work vital And social from life far to stay like A lot factor rhinoplasty surgery before And after that individuals anxiety to live From where is happening . Moreover surgical of the procedure aesthetic for purposes being done to have surgery after that get will be conclusion with relating to obscurity sense of And external appearances given high importance patients anxiety levels affecting other factors aspect is shown . To do to transactions aimed at information lack of patients anxiety level affecting -most basis from factors someone is is stated . patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels reducing And patients improvement of the quality increasing is intended .
patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels can be reduced And service And improvement of the quality can be increased . In this context This research rhinoplasty surgery will be to patients operation pre- given your education request female thoughts And improvement to the quality effect to determine for the purpose of was the plan .
Approach and Methods to be Applied:
of research Place and Time of Making : This research was conducted by Iğdır Dr. It will be carried out at Nevruz Erez State Hospital, Plastic Surgery Clinic between January 2024 and December 2024.
Population and Sample of the Research: Population of the research, Iğdır Dr. Nevruz Erez State Hospital, Plastic Surgery Clinic Patients who underwent rhinoplasty surgery and applied between January 2024 and December 2024 will be created. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria.
Method of the research : It was planned as a randomized controlled experimental.
of research Variables : Dependant Variables : Prompt Female Thoughts Scale , Surgery Post Improvement index Independent Variables : surgery pre- education Control Variables : Patient's age , gender , marital status , education level , more before operation being situation , else One health problem being status Data Collection and Initiatives: Research for First of all , Ataturk University Medicine Faculty Ethic From the Board approval And of research will be carried out from hospitals written permissions will be taken . Necessary permissions after receiving After , January 2024- December 2024 between Iğdır Dr. Research at Nevruz Erez State Hospital, Plastic Surgery Clinic to join acceptance who makes And sample being elected to the criteria wake up patients to work including will be . Research of your data "Patient Introduction " in the meeting Form ", " Request Female Thoughts Scale " and " Surgery Post Improvement Index " will be used . Data collecting tools This way Will be implemented : Researcher by surveys face to the face meeting technique using to patients will be filled . Control in the group patients , surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied. Patients in the control group will receive routine nursing care.
the experimental group to patients from surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Later computer in the environment prepared slide with his offering rhinoplasty process pre- And may develop after complications And at home care process with relating to education will be given . Later prepared education booklet to patients will be given . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied.
Data Collection Tools:
Introductory Information Form: It consists of questions containing the demographic characteristics of the patient, prepared by the researchers in line with the literature for the purpose of collecting research data.
Operation Pre Request Female Thoughts scale Operation pre- in patients happened anxiety to research And operation pre- of anxiety fast One way evaluation to ensure For this purpose, Crockett et al. by has developed . of scale Turkish validity And reliability Cakir and by Karabulut has been made . Control loss concern size And process until later related anxiety size to be about into two subdimensions has . out of 20 items formed This each question of the scale for evaluation: (0) never , (1) sometimes , (2) often chic and (3) mostly shaped and 4-point Likert to type has . From scale 0-60 point can be obtained . 15 or more high One score , clinic aspect important to anxiety reaching patients Trustworthy One way detection it does .
Postoperative Recovery Index (PRI): The Postoperative Recovery Index was developed by Butler et al. in 2012 (26) and was validated in Turkish by Cengiz and Aygin (2019) (27). The index consists of 5 sub-dimensions and 25 items. The sub-dimensions include psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Sub-dimension scores are calculated by summing the relevant item scores and taking their arithmetic mean. The total score is determined by summing all item scores and calculating the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest easier recovery (27). In the study by Cengiz and Aygin, the Cronbach's alpha coefficient for the PRI was determined to be 0.96 (27).
Evaluation of Data: Statistical Package for the Social Science (SPSS) statistical package will be applied in the coding and statistical analysis of the data. Descriptive statistics, t-test for dependent and independent groups, and correlation tests will be used to evaluate the data.
Ethical Aspect of the Research: In order to conduct the research, Ethics Committee approval will be obtained from Atatürk University Faculty of Medicine Ethics Committee Presidency. In addition, Iğdır Dr. where the research will be carried out . Legal permissions will be obtained from Nevruz Erez State Hospital . Since answers must be given voluntarily in all research that obtains information, importance will be given to the voluntary participation of individuals to be included in the research. In addition, their approval (principle of informed consent) will be obtained verbally after the purpose of the research and the purposes for which the results will be used are explained. The "Respect for Autonomy" principle will be fulfilled by stating that they are free to participate in the research or not, and the "Confidentiality and Protection of Confidentiality" principle will be fulfilled by informing the patients participating in the research that their information will be kept confidential. Since individual rights must be protected in research, the Declaration of Helsinki on human rights will be adhered to during the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25100
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Experienced planned nose surgery for the first time,
- Volunteer to participate in the research,
- 18 years and above,
- Mental status is healthy,
- Having no vision, hearing or speech problems,
- Patients who speak Turkish will be included in the study.
Exclusion Criteria
- Having had nose surgery before,
- Communication is a problem,
- Patients who do not want to participate in the study voluntarily will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: standard care and nursing education
Nursing training will be provided the day before the surgery.
|
Nursing training will be given before rhinoplasty surgery.
As a result, patients' involuntary thoughts and quality of recovery will be questioned.
|
|
Other: standard care
Nursing training will not be provided and will only receive standard care in the hospital.
|
Nursing training will be given before rhinoplasty surgery.
As a result, patients' involuntary thoughts and quality of recovery will be questioned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative Intrusive Thoughts Inventory (PITI)
Time Frame: surgery day morning (1 day)
|
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety.
It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes.
The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly.
Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety.
|
surgery day morning (1 day)
|
|
Preoperative Intrusive Thoughts Inventory (PITI)
Time Frame: Day before surgery (1 day)
|
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety. It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes. The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly. Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety. Time Frame: 1 day |
Day before surgery (1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Recovery Index (PRI)
Time Frame: 1st day after surgery
|
The index consists of five sub-dimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms.
Scores range from 25 to 125.
The total score for the PRI general survey is calculated by summing all 25 items and taking the arithmetic mean.
Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest an easier recovery process.
|
1st day after surgery
|
|
Postoperative Recovery Index (PRI)
Time Frame: 1st week after surgery
|
The index consists of five sub-dimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Scores range from 25 to 125. The total score for the PRI general survey is calculated by summing all 25 items and taking the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest an easier recovery process. Time Frame: 1 day and 1 week |
1st week after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: Neziha Karabulut, Prof.Dr., Researcher
- Study Chair: Turgut Şöhret, Lecturer, Researcher
- Study Chair: Yasemin Ay Karadaş, Lecturer, Researcher
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AtaturkUniNursing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Nursing Education
-
Baskent UniversityCompletedNursing Education | Nursing Education ResearchTurkey (Türkiye)
-
China Medical University HospitalChina Medical University, TaiwanNot yet recruitingNursing Students | Breastfeeding Education | Nursing Education Research
-
China Medical University HospitalActive, not recruitingNursing Students | Breastfeeding Education | Nursing Education ResearchTaiwan
-
University of Modena and Reggio EmiliaCompletedNursing Education | Education, Competency-Based | Education, Nursing Students | Active Learning Methods and Life-skills Education | Evidence Based Practice | Evidence Based Programs in Schools | Education Advancement | Evidence Based Nursing | Nursing Education in Evidence-Based PracticeItaly
-
Marmara UniversityNot yet recruitingNursing Education | Nursing Students | Nursing ModelTurkey
-
Ataturk UniversityNot yet recruiting
-
Bilecik Seyh Edebali UniversitesiCompletedEducation, Nursing | Students, NursingTurkey
-
Gazi UniversityNot yet recruitingNursing Education | Ostomy | Stoma Care Education in Nursing Students
-
Baskent UniversityCompletedNursing Education | Virtual Reality | Nursing Education Research | Virtual GogglesTurkey (Türkiye)
-
Duzce UniversityCompletedNursing Students | Nursing Education ResearchTurkey
Clinical Trials on nursing education
-
Jen-Ai Hospital Institutional Review BoardEnrolling by invitation
-
University of Eastern FinlandCompleted
-
Chinese University of Hong KongCompletedType 2 DiabetesHong Kong
-
Bilecik Seyh Edebali UniversitesiCompleted
-
Merve GÃnbaAYThe Scientific and Technological Research Council of TurkeyActive, not recruitingDiabetes Mellitus | Diabetic Foot | Diabetic Foot UlcerTurkey
-
Dicle UniversityAtaturk UniversityNot yet recruitingForensic Nursing Education in Pediatric Nurses | Forensic Competency Training
-
Bilecik Seyh Edebali UniversitesiCompleted
-
Universidad de AntioquiaNot yet recruitingSpirituality | Nursing | Intensive Care (ICU)Colombia
-
Cukurova UniversityEnrolling by invitationCaesarean Section;Stillbirth | Postpartum ComplicationTurkey
-
Izmir Democracy UniversityCompleted