NCT06717217

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_4

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

March 1, 2024

Enrollment Period

20 days

First QC Date

December 1, 2024

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Development of complications

    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 Outcomes (1)

  • Visual Analog Scale

    Postopreative 0.day-6.day

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

WORKING GROUP

EXPERIMENTAL
Procedure: NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY

Interventions

EAR CARE TRAINING

WORKING GROUP

Eligibility Criteria

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ahmed Mohamed Eldesoky, H., & Mahmoud Mahmoud, H. (2019). Effect of Implementing a Nursing Management Protocol on Postoperative Health Outcomes for Patients undergoing Tympanoplasty. Egyptian Journal of Health Care, 10(4), 471-491

    BACKGROUND
  • Millward, K. (2017). Ear care: an update for nurses (part 2). Practice Nursing, 28(8), 332-337

    BACKGROUND
  • Kang E, Gillespie BM, Tobiano G, Chaboyer W. General surgical patients' experience of hospital discharge education: A qualitative study. J Clin Nurs. 2020 Jan;29(1-2):e1-e10. doi: 10.1111/jocn.15057. Epub 2019 Oct 17.

    PMID: 31509311BACKGROUND
  • Jerofke T, Weiss M, Yakusheva O. Patient perceptions of patient-empowering nurse behaviours, patient activation and functional health status in postsurgical patients with life-threatening long-term illnesses. J Adv Nurs. 2014 Jun;70(6):1310-22. doi: 10.1111/jan.12286.

    PMID: 24847530BACKGROUND
  • Miller MJ, Abrams MA, Earles B, Phillips K, McCleeary EM. Improving patient-provider communication for patients having surgery: patient perceptions of a revised health literacy-based consent process. J Patient Saf. 2011 Mar;7(1):30-8. doi: 10.1097/PTS.0b013e31820cd632.

    PMID: 21921865BACKGROUND
  • Ronco M, Iona L, Fabbro C, Bulfone G, Palese A. Patient education outcomes in surgery: a systematic review from 2004 to 2010. Int J Evid Based Healthc. 2012 Dec;10(4):309-23. doi: 10.1111/j.1744-1609.2012.00286.x.

    PMID: 23173656BACKGROUND
  • Gürhan, N., Yaman Sözbir, Ş., & Polat, Ü. (2020). Hemşirelik Alanında Kullanılan Kavram Beceri ve Modeller

    BACKGROUND
  • Kostekli S, Celik S, Keskin E. Evaluation of the effect of endotracheal aspiration at different head heights on oxygenation of the brain by non-invasive method in intensive care patients. J Clin Nurs. 2022 Jun;31(11-12):1709-1720. doi: 10.1111/jocn.16314. Epub 2022 Mar 31.

    PMID: 35362186BACKGROUND
  • Cohen FL. Postsurgical pain relief: patients' status and nurses' medication choices. Pain. 1980 Oct;9(2):265-274. doi: 10.1016/0304-3959(80)90013-5.

    PMID: 7454388BACKGROUND
  • Korkmaz S, Seki Z. Determination of the effect of nursing education given before tympanoplasty surgery on the development of postoperative pain and complications. Pain Manag. 2025 Dec 17:1-13. doi: 10.1080/17581869.2025.2604476. Online ahead of print.

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Şeyda Korkmaz, Master Degree Student

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 4, 2024

Study Start

December 5, 2024

Primary Completion

December 25, 2024

Study Completion

January 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share