Surgery--ComplicationsNCT04862104
The Effect of Discharge Training on Surgical Recovery in Oncology Patients
A study testing Intervention group in people with Surgery--Complications and Nursing Caries, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
A randomized control trial was made to examine the effect of discharge training developed using Nursing Interventions Classification on surgical recovery in patient who underwent oncological surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery--Complications, Nursing Caries
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 27 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 75
- Stomach or colorectal surgery
- Volunteering to participate in research
- Understanding and speaking Turkish
- Having a telephone that can be reached by him or his caregiver
Who cannot join
- Responding to less than 75% of phone calls
- Not having cognitive functions in place
- Having a hearing problem
- Not having a relative to answer in case he / she cannot answer the phone
- Having complications during hospitalization (ileus, septic shock, herniation)
- Having a history of chemotherapy / radiotherapy in the last two months
Show all 9Show fewer
- To receive chemotherapy / radiotherapy within two months after surgery
- Complications developed during surgery
- To be transferred to the intensive care unit after surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Efeler, 09100
About this study
Official title: The Effect of Discharge Training on Surgical Recovery in Oncology Patients: A Randomized Control Trial
A randomized control trial was made to examine the effect of discharge training developed using Nursing Interventions Classification on surgical recovery in patient who underwent oncological surgery.
Read the detailed description
The concept of surgical recovery is defined as "starting activities aimed at maintaining daily life, health and well-being after surgery" and delay in surgical recovery "increasing the number of days after surgery required to start activities aimed at maintaining daily life, health and well-being after surgery". Problems such as fatigue, pain, incisional surgical site infection, loss of appetite, which are common in patients in the postoperative period, are symptoms associated with delayed surgical recovery. In addition to these symptoms, the presence of conditions such as delayed return to home / work activities need for self-care, nausea, anorexia, pain, and difficulty in moving indicate that surgical recovery is interrupted. It has been reported that delay in surgical recovery is common after surgeries such as gastrostomy, colectomy, and exploratory laparotomy.
Patients who have undergone gastric or colorectal cancer surgery should receive discharge training before returning to social life and business life. Nurses should determine the problems they may experience at home in patients who have undergone surgeries such as gastrostomy, colectomy, and exploratory laparotomy, where delay in surgical recovery is frequently reported, plan and apply discharge training for these problems, and monitor patients in terms of surgical recovery processes at home. It has been reported that this way, the surgical recovery process can be supported and delays in surgical recovery can be prevented.
This study was conducted to determine the effect of a discharge training developed using the Nursing Interventions Classification on surgical recovery in patients undergoing oncologic surgery.
It was tested the hypotheses that there was no difference between the post-intervention intervention and control groups in terms of the surgical recovery score averages in patients who had undergone oncologic surgery were tested.
- Conditions
- Surgery--Complications, Nursing Caries
- Being tested
- Intervention group
- Keywords
- Surgical recovery, Discharge Training, Follow-up, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
In addition to the routine care they received, the patients in the intervention groups were given discharge training developed in the pre-discharge period. Discharge training consisted of a verbal and written information booklet containing instructions for the patient and the patient's caregiver on pain management, nutrition management, incision site care, strengthening self-care, returning to daily life activities, and colostomy care. Discharge training was given in the service after evaluating the surgical recovery status of the patient before discharge. The average duration of each training was 30-45 minutes. The patients were evaluated in terms of surgical recovery by calling by phone 2 weeks after discharge, 4 weeks and 8 weeks later. The developed education booklet was given to the patient and it was ensured that he could benefit from the information at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Discharge Training) | Experimental | In addition to the general care provided by health professionals, the study group received discharge training created according to the Nursing Interventions Classification. Receives: Behavioral: Intervention group |
| Control group (Usual Care) | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The surgical recovery score averages in patients
assessed using the Patient Evaluation Form, nine defining features of the diagnosis of "delayed surgical recovery" defined in NANDA-I (delaying starting activities at home / work, understanding that more time is required for recovery/ recovery, need for assistance in self-care practices, evidence indicating impaired surgical site presence (discharge, swelling, redness, pain, presence of one of the bleeding in the area mild; the presence of all will be marked as severe distress), loss of appetite with nausea, loss of appetite without nausea, difficulty in moving around, pain or discomfort, fatigue) It contains questions.
The patient evaluation form was created using the Nursing Outcomes Classification of the five-point Likert-type scale measuring the severity of descriptive features. The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no
Measured: before discharge in the postoperative days
The surgical recovery status after intervention
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the second week after discharge.
Measured: In the second weeks after discharge
The surgical recovery status after intervention
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the fourth week after discharge.
Measured: In the fourth weeks after discharge
The surgical recovery status after intervention
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the eighth week after discharge.
Measured: In the eighth weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Aug 2018
- Primary completion31 Jul 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Model description
- Following recruitment, patient who underwent oncological surgery were divided into a study and a control group by randomization (1:1 randomization)
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
- Investigators
- Ezgi Arslan, PhD Student, Principal investigator, Aydın Adnan Menderes University, Faculty of Nursing, Surgical Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862104
- Sponsor's protocol ID
- Surgical Recovery
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Arslan E, Gezer N. The effect of discharge training developed based on nursing interventions classification (NIC) on surgical recovery in oncology patients: Randomized controlled trial - A pilot study. Nurs Open. 2023 Feb;10(2):1151-1162. doi: 10.1002/nop2.1555. Epub 2022 Dec 25.
PubMed 36567264
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discharge Training on Surgical Recovery in Oncology Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04862104
- Acronym / sponsor ID
- Surgical Recovery
- Conditions
- Surgery--Complications, Nursing Caries
- Keywords
- Surgical recovery, Discharge Training, Follow-up, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 27 Apr 2021 (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.
A randomized control trial was made to examine the effect of discharge training developed using Nursing Interventions Classification on surgical recovery in patient who underwent oncological surgery.
Detailed description
The concept of surgical recovery is defined as "starting activities aimed at maintaining daily life, health and well-being after surgery" and delay in surgical recovery "increasing the number of days after surgery required to start activities aimed at maintaining daily life, health and well-being after surgery". Problems such as fatigue, pain, incisional surgical site infection, loss of appetite, which are common in patients in the postoperative period, are symptoms associated with delayed surgical recovery. In addition to these symptoms, the presence of conditions such as delayed return to home / work activities need for self-care, nausea, anorexia, pain, and difficulty in moving indicate that surgical recovery is interrupted. It has been reported that delay in surgical recovery is common after surgeries such as gastrostomy, colectomy, and exploratory laparotomy.
Patients who have undergone gastric or colorectal cancer surgery should receive discharge training before returning to social life and business life. Nurses should determine the problems they may experience at home in patients who have undergone surgeries such as gastrostomy, colectomy, and exploratory laparotomy, where delay in surgical recovery is frequently reported, plan and apply discharge training for these problems, and monitor patients in terms of surgical recovery processes at home. It has been reported that this way, the surgical recovery process can be supported and delays in surgical recovery can be prevented.
This study was conducted to determine the effect of a discharge training developed using the Nursing Interventions Classification on surgical recovery in patients undergoing oncologic surgery.
It was tested the hypotheses that there was no difference between the post-intervention intervention and control groups in terms of the surgical recovery score averages in patients who had undergone oncologic surgery were tested.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, patient who underwent oncological surgery were divided into a study and a control group by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Discharge Training) | Experimental | Behavioral: Intervention groupIn addition to the general care provided by health professionals, the study group received discharge training created according to the Nursing Interventions Classification. |
| Control group (Usual Care) | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages between 18 and 75
- Stomach or colorectal surgery
- Volunteering to participate in research
- Understanding and speaking Turkish
- Having a telephone that can be reached by him or his caregiver
Key exclusion criteria (9 listed)
- Responding to less than 75% of phone calls
- Not having cognitive functions in place
- Having a hearing problem
- Not having a relative to answer in case he / she cannot answer the phone
- Having complications during hospitalization (ileus, septic shock, herniation)
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 |
|---|---|---|
| Intervention groupIn addition to the routine care they received, the patients in the intervention groups were given discharge training developed in the pre-discharge period. Discharge training consisted of a verbal and written information booklet containing instructions for the patient and the patient's caregiver on pain management, nutrition management, incision site care, strengthening self-care, returning to daily life activities, and colostomy care. Discharge training was given in the service after evaluating the surgical recovery status of the patient before discharge. The average duration of each training was 30-45 minutes. The patients were evaluated in terms of surgical recovery by calling by phone 2 weeks after discharge, 4 weeks and 8 weeks later. The developed education booklet was given to the patient and it was ensured that he could benefit from the information at home. | Behavioural | Intervention group (Discharge Training) |
Primary outcome
The surgical recovery score averages in patients
Time frame: before discharge in the postoperative days
assessed using the Patient Evaluation Form, nine defining features of the diagnosis of "delayed surgical recovery" defined in NANDA-I (delaying starting activities at home / work, understanding that more time is required for recovery/ recovery, need for assistance in self-care practices, evidence indicating impaired surgical site presence (discharge, swelling, redness, pain, presence of one of the bleeding in the area mild; the presence of all will be marked as severe distress), loss of appetite with nausea, loss of appetite without nausea, difficulty in moving around, pain or discomfort, fatigue) It contains questions. The patient evaluation form was created using the Nursing Outcomes Classification of the five-point Likert-type scale measuring the severity of descriptive features. The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no
The surgical recovery status after intervention
Time frame: In the second weeks after discharge
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the second week after discharge.
The surgical recovery status after intervention
Time frame: In the fourth weeks after discharge
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the fourth week after discharge.
The surgical recovery status after intervention
Time frame: In the eighth weeks after discharge
assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the eighth week after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 36567264Arslan E, Gezer N. The effect of discharge training developed based on nursing interventions classification (NIC) on surgical recovery in oncology patients: Randomized controlled trial - A pilot study. Nurs Open. 2023 Feb;10(2):1151-1162. doi: 10.1002/nop2.1555. Epub 2022 Dec 25.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Ezgi Arslan, PhD Student principal investigator
Aydın Adnan Menderes University, Faculty of Nursing, Surgical Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Surgery--Complications and Nursing Caries, run by Aydin Adnan Menderes 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 29 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The surgical recovery score averages in patients (time frame: before discharge in the postoperative days). The study lists 4 primary outcomes in all. 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 NCT04862104, which also lists 1 linked publication.
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 29 Apr 2021.