- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342479
Discharge Training for Patients With Intertrochanteric Fracture
The Effect of Discharge Training Given to Patients Having Intertrochanteric Fracture Surgery on Discharge Readiness and Surgical Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose of the study: This study will be conducted to determine whether the discharge training given to patients who underwent intertrochanteric femur fracture surgery has an effect on surgical recovery and readiness for discharge. The research is prospective and aimed to be a case-control group. The universe of the research; It will consist of patients hospitalized in the orthopedics service of Elazığ Fethi Sekin City Hospital and Fırat University Faculty of Medicine Research Hospital. The sample is; With the power analysis, 60 patients will constitute the population with a 0.05 error, 0.95 confidence interval, 0.6 effect size, and a representative power of 0.80. (n=60) Patients will be divided into 30 intervention groups and 30 control groups. Sociodemographic form, Toronto Wound Symptom Evaluation System Discharge readiness scale and patient evaluation form The data of the research will be collected using. Since the scales are publicly available, no permission will be sought from the authors. The research will be conducted with 60 patients who were hospitalized in the orthopedic clinic and underwent intertrochanteric femur fracture surgery. Groups will be divided into 30 intervention and 30 control groups. In order to prevent patients from interacting with each other during repeated measurements within the institution, 30 people were first admitted to the hospital. Control group; The next 30 people will constitute the intervention group patients.
- Type of research: The research is prospective and aimed to be a case-control group.
Research questions/hypotheses:
- What are the socio-demographic characteristics of the participants?
- Does the discharge training given to participants have an effect on surgical recovery?
- Is there any difference in surgical recovery according to the socio-demographic characteristics of the participants?
- Population-sample: The universe of the research; It will consist of patients hospitalized in the orthopedics service of Elazığ Fethi Sekin City Hospital and Fırat University Faculty of Medicine Research Hospital. The sample is; With the power analysis, 60 patients will constitute the population with a 0.05 error, 0.95 confidence interval, 0.6 effect size, and a representative power of 0.80. (n=60) Patients will be divided into 30 intervention groups and 30 control groups.
It is aimed to collect data face to face after obtaining ethics committee permission and institutional permission, and obtaining the necessary permissions from Elazığ Fethi Sekin City Hospital and Fırat University Faculty of Medicine Research Hospital. Before filling out the survey form, you will be informed about the research and a voluntary consent form will be read. All patients who agree will be included in the study. The research is aimed to be conducted between April 1 and December 1, 2023. All this operation will be carried out in accordance with the Declaration of Helsinki.
- Data collection tools: Sociodemographic form, Toronto Wound Symptom Evaluation System Discharge readiness scale and patient evaluation form The data of the research will be collected using. Since the scales are publicly available, no permission will be sought from the authors.
- How data will be collected: The research will be conducted with 60 patients who were hospitalized in the orthopedic clinic and underwent intertrochanteric femur fracture surgery. Groups will be divided into 30 intervention and 30 control groups. In order to prevent patients from interacting with each other during repeated measurements within the institution, 30 people were first admitted to the hospital. Control group; The next 30 people will constitute the intervention group patients.
After the patients included in the intervention group were evaluated in terms of the study participation criteria, they were informed by the researcher about the purpose, expected benefits and method of the study; Verbal and written informed consent forms will be obtained. The patient, for whom an informed consent form is obtained before discharge, will be evaluated for surgical recovery before discharge training is given. After the first evaluation, the standard clinical monitoring applied in the clinic in a quiet and calm environment in the patient's room, outside the doctor's visit, meal time, visiting and treatment hours, and approximately two hours after the painkiller application, in addition to the standard clinical monitoring, which takes approximately 30 minutes (with the topics in the developed booklet). Patients will be given discharge training (such as nutrition, surgical recovery, movement, excretion, self-care skills, pain, exercise). The patient will be asked to demonstrate the trainings (movements, exercises, etc.) that are explained to the patient by doing them at least three times. At the end of the training, a booklet prepared in accordance with the surgery the patient underwent will be given to the patient. Before the face-to-face interview with the patient is terminated, a telephone number will be obtained from the patient so that the evaluations can be made in the second, fourth and eighth weeks. In the second week after discharge, the researcher will call the patient from the phone number given by the patient and the questions in the section of the patient follow-up form created for the second week will be asked to the patient. The patient evaluation form will continue to be applied in the fourth and eighth weeks, as in the second week. When ending each phone call with the patient, information will be given about the time of the next phone call. Phone calls are planned to last approximately 10 minutes. In the second, fourth and eighth weeks after discharge, the application will continue as in the intervention group. After the study is completed, the developed discharge training booklets will be delivered to the control group patients.
- Evaluation of data: Data will be recorded and analyzed using the SPSS statistical package program.
- Difficulties and limitations of the research: The person may want to leave the study at a later time without stating any reason. Since the study is planned prospectively, the person may leave the study due to death or change of province.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasemin Erden
- Phone Number: 05303461516
- Email: yasemin.erden@erzurum.edu.tr
Study Locations
-
-
-
Erzurum, Turkey, 25000
- Recruiting
- Erzurum Technical University Faculty of Health Sciences
-
Contact:
- Yasemin Erden
- Phone Number: 05303461516
- Email: yasemin.erden@erzurum.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak and understand Turkish,
- At least primary school graduate,
- Patients who underwent intertrochanteric femur fracture surgery,
- Patients aged 18 and over will be included in the study.
Exclusion Criteria:
- Those who have a physical disability (such as vision, hearing, mobility) that prevents them from taking care of themselves,
- Those who have been diagnosed with a psychiatric disease (Dementia, Alzheimer, etc.)
- Those who have previously received discharge training
- Patients who are illiterate will be excluded from discharge training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Discharge training given
In addition to the standard clinical monitoring applied in the clinic in a quiet and calm environment in the patient's room, outside of the doctor's visit, meal time, visiting and treatment hours and approximately two hours after the painkiller application, approximately 30 minutes (related to the subjects included in the developed booklet, nutrition, Discharge training (such as surgical recovery, movement, excretion, self-care skills, pain, exercise) will be given to patients.
The patient will be asked to demonstrate the trainings (movements, exercises, etc.) that are explained to the patient by doing them at least three times.
At the end of the training, a booklet prepared in accordance with the surgery the patient underwent will be given to the patient.
|
Discharge education will be provided.
|
|
No Intervention: No discharge training provided
Patients included in the control group will receive routine discharge training and clinical follow-up at the Orthopedics Clinic.
During standard clinical follow-up, service nurses provide verbal information to patients hospitalized in the Orthopedic Clinic about wound care, signs of infection at the wound site, medication use and post-discharge control times before discharge, but no written training materials are used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toronto Wound Symptom Assessment System
Time Frame: 6months
|
The Toronto Wound Symptom Assessment System-TYSDS was developed to evaluate the symptoms of patients with chronic wounds in 2009.
Toronto Wound Symptom Assessment System - TYSDS is a tool consisting of 10 questions and each question gives a total of 11 points between 0-10.
0 in each question means that the symptom is not observed, and 10 means that the symptom is seen very intensely.
A minimum score of 0 and a maximum of 100 points are obtained from the scale, and increasing scores indicate that the wound symptoms are more intense.
|
6months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge readiness scale
Time Frame: 6months
|
The scale is a 10-point Likert type scale, and if the average score from the scale is between 9-10, you are very ready to be discharged; if it is 8-8.9, you are very ready; if it is between 7-7.9, you are moderately ready; if it is below 7, you are very ready to be discharged.
It is considered low readiness.
Cronbach's alpha value of the discharge readiness scale was found to be .75.
|
6months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yasemin Erden, 54 / 5.000 Çeviri sonuçları Çeviri sonucu Erzurum Technical University Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- NM: 04.20.ND:30.03.2023
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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