Nursing EducationPhase 4NCT06717217
Determinating the Effect of Nursing Education Given Before Tympanoplasty Surgery on Postoperative Pain and Complications
A Phase 4 study testing NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY in people with Nursing Education and Postoperative Pain, run by Muğla Sıtkı Koçman University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nursing Education, Postoperative Pain, Postoperative Complications
- What is being tested?
- NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Nursing Education, Postoperative Pain, Postoperative Complications, Tympanoplasty Surgery, ENT Surgery
- Being tested
- NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERYProcedure or surgery
EAR CARE TRAINING
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | Not described |
| WORKING GROUP | Experimental | Not described Receives: Procedure: NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postopreative 0.day-6.day
Secondary outcomes (1)
Visual Analog Scale
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).
Measured: Postopreative 0.day-6.day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start5 Dec 2024 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda KORKMAZ, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717217
- Sponsor's protocol ID
- MSKU-ENT-KORKMAZ-001
- Status last verified
- Mar 2024
- First submitted
- 1 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Millward, K. (2017). Ear care: an update for nurses (part 2). Practice Nursing, 28(8), 332-337
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.
PubMed 31509311Jerofke 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.
PubMed 24847530Miller 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.
PubMed 21921865Ronco 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.
PubMed 23173656Gürhan, N., Yaman Sözbir, Ş., & Polat, Ü. (2020). Hemşirelik Alanında Kullanılan Kavram Beceri ve Modeller
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.
PubMed 35362186Cohen 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.
PubMed 7454388Korkmaz S, Seki Z. Determination of the effect of nursing education given before tympanoplasty surgery on the development of postoperative pain and complications. Pain Manag. 2026 Mar;16(3):201-213. doi: 10.1080/17581869.2025.2604476. Epub 2025 Dec 17.
PubMed 41404828
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinating the Effect of Nursing Education Given Before Tympanoplasty Surgery on Postoperative Pain and Complications
- ClinicalTrials.gov ID
- NCT06717217
- Acronym / sponsor ID
- MSKU-ENT-KORKMAZ-001
- Conditions
- Nursing Education, Postoperative Pain, Postoperative Complications, Tympanoplasty Surgery, ENT Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | – |
| WORKING GROUP | Experimental | Procedure: NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERYEAR CARE TRAINING | Procedure or surgery | WORKING GROUP |
Primary outcome
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).
1 secondary outcome
Visual Analog Scale
Time frame: Postopreative 0.day-6.day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- BackgroundAhmed 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
- BackgroundMillward, K. (2017). Ear care: an update for nurses (part 2). Practice Nursing, 28(8), 332-337
- Background: PubMed 31509311Kang 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.
- Background: PubMed 24847530Jerofke 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.
- Background: PubMed 21921865Miller 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.
- Background: PubMed 23173656Ronco 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.
- BackgroundGürhan, N., Yaman Sözbir, Ş., & Polat, Ü. (2020). Hemşirelik Alanında Kullanılan Kavram Beceri ve Modeller
- Background: PubMed 35362186Kostekli 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.
- Background: PubMed 7454388Cohen 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.
- Derived from this study: PubMed 41404828Korkmaz S, Seki Z. Determination of the effect of nursing education given before tympanoplasty surgery on the development of postoperative pain and complications. Pain Manag. 2026 Mar;16(3):201-213. doi: 10.1080/17581869.2025.2604476. Epub 2025 Dec 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NURSING EDUCATION GIVEN BEFORE TYMPANOPLASTY SURGERY in people with Nursing Education and Postoperative Pain, run by Muğla Sıtkı Koçman University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şeyda Korkmaz, Master Degree Student (+90 533 793 01 37, sseydakorkmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of complications (time frame: Postopreative 0.day-6.day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06717217, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.