Surgical WoundNCT06342479
Discharge Training for Patients With Intertrochanteric Fracture
A study testing Discharge Education in people with Surgical Wound, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Discharge Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jul 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzurum Technical University Faculty of Health Sciences
Erzurum, 25000
Yasemin Erden, 05303461516, yasemin.erden@erzurum.edu.tr
About this study
Official title: The Effect of Discharge Training Given to Patients Having Intertrochanteric Fracture Surgery on Discharge Readiness and Surgical Recovery
This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically.
Read the 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.
- Conditions
- Surgical Wound
- Being tested
- Discharge Education
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge EducationBehavioural
Discharge education will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Discharge training given | Experimental | 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. Receives: Behavioral: Discharge Education |
| No discharge training provided | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Toronto Wound Symptom Assessment System
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.
Measured: 6months
Secondary outcomes (1)
Discharge readiness scale
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.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Sep 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Erden, Erzurum Technical University
- Investigators
- Yasemin Erden, Study director, 54 / 5.000 Çeviri sonuçları Çeviri sonucu Erzurum Technical University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342479
- Sponsor's protocol ID
- NM: 04.20.ND:30.03.2023
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discharge Training Given to Patients Having Intertrochanteric Fracture Surgery on Discharge Readiness and Surgical Recovery
- ClinicalTrials.gov ID
- NCT06342479
- Acronym / sponsor ID
- NM: 04.20.ND:30.03.2023
- Conditions
- Surgical Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 2 Apr 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.
This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discharge training given | Experimental | Behavioral: Discharge EducationIn 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. |
| No discharge training provided | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Discharge EducationDischarge education will be provided. | Behavioural | Discharge training given |
Primary outcome
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.
1 secondary outcome
Discharge readiness scale
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Yasemin Erden study director
54 / 5.000 Çeviri sonuçları Çeviri sonucu Erzurum Technical University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge Education in people with Surgical Wound, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Yasemin Erden (05303461516, yasemin.erden@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Wound Symptom Assessment System (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.