Clinical trial NCT06717217: Determinating the Effect of Nursing Education Given Before Tympanoplasty Surgery on Postoperative Pain and Complications
Official title: Determinating the Effect of Nursing Education Given Before Tympanoplasty Surgery on Postoperative Pain and Complications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Nursing Education
Postoperative Pain
Postoperative Complications
Tympanoplasty Surgery
ENT Surgery
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of complications
timeFrame: Postopreative 0.day-6.day
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Postopreative 0.day-6.day
Other outcomes:
Locations:
Study officials:
References:
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