NCT06771297

Brief Summary

With planned trainings prepared by taking into account the needs of patients and given by nurses, levels of anxiety and involuntary thoughts can be reduced and the quality of service and recovery can be increased. In this context, this research was planned to determine the effect of preoperative education given to patients undergoing rhinoplasty surgery on involuntary thoughts and recovery quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

June 26, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

rhinoplastynursinginvoluntary thoughtquality of recoveryeducation

Outcome Measures

Primary Outcomes (2)

  • Preoperative Intrusive Thoughts Inventory (PITI)

    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)

    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 Outcomes (2)

  • Postoperative Recovery Index (PRI)

    1st day after surgery

  • Postoperative Recovery Index (PRI)

    1st week after surgery

Study Arms (2)

standard care and nursing education

EXPERIMENTAL

Nursing training will be provided the day before the surgery.

Other: nursing education

standard care

OTHER

Nursing training will not be provided and will only receive standard care in the hospital.

Other: nursing education

Interventions

Nursing training will be given before rhinoplasty surgery. As a result, patients' involuntary thoughts and quality of recovery will be questioned.

standard carestandard care and nursing education

Eligibility Criteria

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

You may qualify if:

  • Experienced planned nose surgery for the first time,
  • Volunteer to participate in the research,
  • years and above,
  • Mental status is healthy,
  • Having no vision, hearing or speech problems,
  • Patients who speak Turkish will be included in the study.

You may not qualify if:

  • Having had nose surgery before,
  • Communication is a problem,
  • Patients who do not want to participate in the study voluntarily will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Nursing Education Research

Intervention Hierarchy (Ancestors)

Nursing ResearchNursing ProcessComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Neziha Karabulut, Prof.Dr.

    Researcher

    STUDY CHAIR
  • Turgut Şöhret, Lecturer

    Researcher

    STUDY CHAIR
  • Yasemin Ay Karadaş, Lecturer

    Researcher

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were not told which group they were in. In this way, single blinding was achieved.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The population of the research is Iğdır, Dr. Patients who underwent rhinoplasty surgery and applied to Nevruz Erez State Hospital Plastic Surgery Clinic and Ear, Nose and Throat Clinic between January 2024 and December 2024 were included. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria. The sample was determined by G-Power.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 26, 2024

First Posted

January 13, 2025

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
January 2024- December 2024

Locations