- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323160
Determining the Effect of Education Given to Patients Undergoing Outpatient Anal Fistula Surgery (anal fistula)
Determining the Effect of Discharge Education Provided Using the Teaching-back Method on Readmission Rates and Patient Satisfaction in Patients Undergoing Same-day Anal Fistula Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Day surgery refers to surgical procedures in which the patient is admitted to the clinic on the same day, undergoes surgery, and is discharged within 24 hours. This approach is increasingly being implemented due to its cost-effectiveness, reduced risk of infection, minimally invasive nature, faster recovery, lower risk, and shorter hospital stay. One type of surgery currently performed on a day case basis is anorectal surgery, including anal fistula surgery.
An anal fistula is characterized by a chronic infection between the anorectal canal and the perianal skin. It often develops after a perianal abscess and carries a high risk of recurrence. Complex anal fistulas, due to their anatomical complexity, pose significant complications and risks not only from a surgical perspective but also from a nursing care perspective. These patients require careful management due to high recurrence rates, post-treatment complications, and decreased quality of life. Studies on the subject indicate that anal fistula patients experience chronic complaints such as pain, discharge, recurrence, and a decrease in quality of life. These complaints can lead to social isolation, depression, and sleep disturbances. The disrupted sleep patterns and limitations in daily activities caused by pain and drainage significantly impact these patients' quality of life. Therefore, the importance of providing individualized education, such as supporting patients with educational brochures and providing emergency contact information, is emphasized to ensure active participation in their own care after anal fistula surgery, adherence to the recommended treatment plan, and maintenance of surgical success. Furthermore, while outpatient surgeries reduce hospital costs and increase patient satisfaction, they also reduce the time healthcare professionals spend with the patient. This limits patient interaction with healthcare professionals and leads to increased caregiving responsibilities being assigned to the patient and their families. During this period, patients' lack of knowledge and inadequate education regarding the post-discharge period leads to postoperative pain, bleeding, wound care, medication management, anal hygiene, and difficulty recognizing signs of complications, leading to re-admissions to the hospital, increased risk of complications, and prolonged recovery. Patient education, a crucial aspect of clinical practice and patient care, is crucial for ensuring continuity of care for these patients, supporting their recovery at home, and preventing the risk of recurrence, complications, and hospital readmissions. This highlights the importance of nurses involved in the care of these patients to take an active role not only in physical care practices but also in patient education, psychosocial support, and postoperative follow-up. Despite education on care and complications after anal fistula surgery, patients are reported to experience anxiety regarding issues such as bleeding, pain, and wound care and tend to forget 40-80% of the information provided. Furthermore, existing studies indicate that education generally focuses on surgical technique and anatomical factors, while factors directly related to nursing care and education, such as patient education and health literacy, are not adequately addressed. Health education is an intervention that empowers individuals to actively participate in decision-making processes regarding their own health and is a fundamental element of nursing care. Discharge education, a key component of health education, increases patient awareness of potential postoperative complications and their early symptoms, supports self-care at home, and accelerates the recovery process. It also contributes to improving health outcomes, including hospital readmissions, and enhancing patient satisfaction. To achieve this, it is emphasized that discharge education should shift from traditional healthcare provider-centered, one-way education to patient-centered education based on patient-caregiver interaction. Therefore, the Agency for Healthcare Research and Quality recommends using an effective education method, such as the teach-back method, to teach patients complex health information in clinical settings and facilitate their understanding of discharge education. Teach-back is a patient-centered education strategy used to teach patients complex health information. This method allows healthcare providers to confirm whether they are educating the patient correctly and how accurately the patient understands the health information. Furthermore, consistently re-educating patients about misunderstood information helps them better remember information. Education using this method has been associated with positive health outcomes, including self-care and the use of healthcare resources. However, for patient education to be effective, the level of health literacy, which defines an individual's capacity to understand, interpret, evaluate, and apply health information and directly impacts their adherence to treatment, should also be considered. Studies indicate that individuals with inadequate health literacy levels struggle to understand and implement recommendations for post-discharge care. They struggle to perform tasks such as understanding physician instructions, reading patient information leaflets, and following post-operative care procedures. This leads to complications, re-admissions, and increased costs. While studies evaluating the impact of health literacy after general surgery exist, no studies specifically evaluating health literacy and discharge education for anal fistula surgery are available. Furthermore, further research is needed to improve the quality of postoperative care after anal fistula surgery and to better understand the factors contributing to unplanned hospital returns. This randomized controlled study, designed to address this need, aimed to determine the impact of discharge education provided through the teach-back method on hospital re-admissions and patient satisfaction in outpatient anal fistula surgery patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cemile Yaşar, Nurse
- Phone Number: +905530954397
- Email: cemileyasar720@gmail.com
Study Contact Backup
- Name: Gülşah Köse, Associate professor
- Phone Number: +905333829280
- Email: gulsahkose@mu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a day surgery planned, Being admitted to the Proctology Unit for anal fistula surgery, Being undergoing elective anal fistula surgery for the first time, Being planned to have a surgical procedure performed with local anesthesia, Being over 18 years of age, Being able to read and understand Turkish, Being able to read and understand the research instructions, Being literate, Agreeing to participate in the research.
Exclusion Criteria:
- Having surgery planned with general anesthesia, Requiring general anesthesia during the surgical procedure, Being hospitalized for more than 24 hours, Having a recurrent anal fistula, Having another anorectal disease besides the anal fistula, such as advanced Crohn's disease or colorectal cancer, Having complications within 24 hours of surgery and rescheduling surgery, Having visual, auditory, or cognitive problems, Having agreed to participate in the study but wishing to withdraw during follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teach-back discharge education
Participants receive discharge education using the teach-back method.
|
For the Experimental Group: Intervention Name: Teach-back discharge education Intervention Type: Behavioral Description: Discharge education provided using the teach-back method. For the Control Group: Intervention Name: Routine discharge education Intervention Type: Behavioral Description: Standard discharge education provided without teach-back. |
|
No Intervention: Routine discharge education
Participants receive routine discharge education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of teach-back discharge education on postoperative readmission and patient satisfaction
Time Frame: Within 30 days after surgery
|
The rate of hospital readmissions within the follow-up period and the mean patient satisfaction scores will be compared between the teach-back discharge education group and the routine discharge education group to evaluate the effect of the intervention.
|
Within 30 days after surgery
|
|
Discharge Education Satisfaction Scale
Time Frame: within 30 days after surgery
|
Discharge Education Satisfaction Scale (TEMÖ): It was developed by Meşe and Köşgeroğlu in 2018 to determine the satisfaction of patients or their relatives who underwent surgical intervention with discharge education.
The scale items include 21 items related to the discharge process, home care, medication, pain, infection, exercise, and postoperative follow-up.
The minimum score that can be obtained from the scale is 21, and the maximum score is 105.
TEMÖ is a 5-point Likert-type scale, and the scale items are scored as "completely satisfied" (5), "satisfied" (4), "partially satisfied" (3), "not satisfied" (2), and "not satisfied at all" (1).
The scale has no cut-off point, and higher scores indicate higher satisfaction with discharge education.
The Cronbach's alpha coefficient was 0.91 in the original scale, and total item correlation scores were found to range between 0.42 and 0.64 (Meşe, 2018).
Permission was obtained from Sevinç Meşe for the use of the scale in the study.
|
within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Rectal Diseases
- Digestive System Fistula
- Fistula
- Intestinal Fistula
- Pathological Conditions, Signs and Symptoms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Rectal Fistula
- Patient Satisfaction
Other Study ID Numbers
- MSKU Ethics Committe No:250098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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