Determinating the Effect of Nursing Education Given Before Tympanoplasty Surgery on Postoperative Pain and Complications

December 4, 2024 updated by: Şeyda KORKMAZ, Muğla Sıtkı Koçman University

Health and illness are complex, universal ideas addressed from a holistic approach. Advancements in healthcare have led to an increase in life expectancy, a rise in the prevalence of chronic diseases, and an escalation in the number of surgical procedures conducted . Surgical techniques influence individuals' health and illness progression. Patients having surgical operations require the attention of nurses and other healthcare workers to address the ramifications of the procedure .

Nurses have performed numerous responsibilities in patient care. These tasks pertain to expediting recovery post-illness and maintaining health continuity. Discharge training is also incorporated into the processes implemented to meet these responsibilities. Discharge training seeks to expedite recovery and mitigate the onset of problems. Discharge training is essential for equipping surgical patients with the requisite information and abilities for post-discharge care.

Ear, Nose, and Throat (ENT) surgeries significantly influence persons' quality of life, as they impact hearing and balance, distinguishing them from other surgical interventions. Consequently, patient care and discharge education following ear surgery play a crucial role in recovery and health enhancement.

The ears serve as the organs of auditory perception and equilibrium. Tympanoplasty is performed on individuals with tympanic membrane perforations or ossicular chain injury that impairs hearing and balance. Tympanoplasty is a surgical intervention that entails the restoration of the ossicular chain (malleus, incus, stapes) and/or the installation of a fascia graft to restore auditory function.

This study aims to assess the impact of preoperative nurse education on postoperative pain and complication rates following tympanoplasty.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This research will take place at the Otorhinolaryngology department of Hacettepe University Adult Hospital. The objective is to track pain progression and problems during the postoperative period through ear care instruction provided to patients prior to tympanoplasty surgery, leading to the establishment of a quasi-experimental research design. The study seeks to assess pain and complications during the early surgical phase (first 24 hours) and at the first post-discharge follow-up (subsequent interval).

Based on the calculations conducted with the G Power 3.1 program, it was determined to include 56 patients in the trial, with 28 assigned to the experimental group and 28 to the control group. The experimental group is scheduled to receive ear care instruction alongside standard preoperative treatment. The control group will receive only standard treatment without any further interventions. The postoperative period will involve an assessment of pain and complication development in both groups during the early (first 24 hours) and late (first follow-up after discharge) phases.

The postoperative pain levels of the patients will be assessed using the Visual Analog Scale (VAS). The assessment will include pain within the first 24 hours postoperatively and early complications such as hemorrhage, hematoma, hypothermia, hyperthermia, tachycardia, nausea, vomiting, hypotension, hypertension, and alveolar collapse. Subsequent complications, including pain, delayed wound healing, wound infection characterized by erythema, localized hyperthermia, edema, wound dehiscence, abscess formation, necrosis at the wound site due to insufficient nutrition and improper closure, and cellulitis, will be assessed during the initial post-discharge evaluations.

Study Hypotheses H01: Nursing education provided before to tympanoplasty surgery does not influence postoperative pain levels.

H11:Nursing education administered before to tympanoplasty surgery influences postoperative pain levels.

H02:Nursing education provided before to tympanoplasty surgery does not influence postoperative complications.

H03:Nursing education provided prior to tympanoplasty surgery influences the occurrence of postoperative problems.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Criteria for Inclusion

  • Patients who consented to participate in the study
  • Patients with literacy skills
  • Individuals aged 18 to 65 years
  • Individuals who have received tympanoplasty surgery
  • Patients were monitored preoperatively and postoperatively at Hacettepe University Adult Hospital.

Criteria for Exclusion:

  • Patients who declined to participate in the study
  • Patients receiving tympanoplasty for cholesteatoma. Assessing the progression of issues in individuals diagnosed with cholesteatoma (abnormal skin epithelial growth in the middle ear cavity) is inappropriate due to the presence of repeated perforations and aberrant tissue proliferation.
  • Individuals with psychological disorders
  • Patients who are foreign nationals.
  • Individuals with speech impairments and irreversible hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
Experimental: WORKING GROUP
Procedure: NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY
EAR CARE TRAINING

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of complications
Time Frame: Postopreative 0.day-6.day

These issues typically arise within the initial 24 hours post-surgery. These encompass hemorrhage/hematoma, hypothermia/hyperthermia, arrhythmia, nausea/emesis, hypotension/hypertension, and pulmonary collapse/atelectasis.

Late complications refer to those that may arise after the third postoperative day. The complications encompass delayed wound healing, wound infection (characterized by localized temperature elevation, edema, and erythema), wound dehiscence, wound abscess, cellulitis, and psychological issues (Manekk et al., 2022).
Postopreative 0.day-6.day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Postopreative 0.day-6.day

The Visual Analog Scale (VAS) is a self-administered instrument including a horizontal or vertical line, typically 10 cm in length (100 mm), with two spoken descriptors indicating pain levels at either end. A modification in the visual analog scale score signifies a relative alteration in the intensity of the pain feeling. The patient is requested to denote their perceived pain intensity on a 100 mm horizontal line, with the measurement taken from the left edge to determine the VAS score. The VAS score exhibits a strong correlation with acute pain levels (Chiarotto et al., 2019).

The patient is requested to evaluate their pain using a scale from 0 to 10, where 0 signifies no pain and 10 represents the most severe pain conceivable (Shafshak & Elnemr, 2021).
Postopreative 0.day-6.day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 5, 2024

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSKU-ENT-KORKMAZ-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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