Enteral NutritionNCT06234163
The Effect of Enteral and Parenteral Nutrition Training
A study testing Assigned intervention in people with Enteral Nutrition and Parenteral Nutrition, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
Malnutrition is considered as a deficiency of energy, protein or other nutrients. Malnutrition is a big problem for surgical patients. Various physiological problems may occur in patients with inadequate or malnutrition, such as prolonged wound healing time, decreased muscle strength and deterioration in immune system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition, Parenteral Nutrition, Nursing Care
- What is being tested?
- Assigned intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 29 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having the title of nurse
- Working in a surgical ward or surgical intensive care unit
- Volunteering to participate in the study
Who cannot join
- filling out forms incompletely
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elif ALTINKAYNAK SARAL
Sinop, Sinop University, 5700
About this study
Official title: The Effect of Enteral and Parenteral Nutrition Training Applied to Surgical Nurses on Their Knowledge Level and Care Behaviors Regarding Nutritional Care: Randomized Controlled Study
Malnutrition is considered as a deficiency of energy, protein or other nutrients. Malnutrition is a big problem for surgical patients. Various physiological problems may occur in patients with inadequate or malnutrition, such as prolonged wound healing time, decreased muscle strength and deterioration in immune system functions. It is recommended to start oral nutrition in the early postoperative period. In cases where the oral route is not preferred, enteral and parenteral nutritional support should be provided to the patient continuously or intermittently. Failure to identify individuals at risk of malnutrition means delaying the nutritional support the patient needs. Close observations and evaluations made by nurses during the day can ensure early diagnosis of the patient at risk of malnutrition and receive the necessary nutritional support. In order for nurses to fulfill their duties regarding nutritional care, they must have sufficient knowledge and skills on the subject and perceive the importance of nutritional care for patients. "Care" forms the basis of nursing. The interaction between patient and nurse affects the process and quality of care. Care behaviors include some basic skills such as listening carefully to the patient by making eye contact, empathy, demonsrating professional knowledge and skills, taking responsibility for the patient, and being accessible. In order to increase the quality of nursing care given to patients, it is necessary to provide evidence-based care and ensure that the care given is compatible with the values and expectations of the patients. For these reasons, this study aimed to examine the effect of enteral and parenteral nutrition (EPN) training on the knowledge level and care behaviors of surgical nurses regarding nutritional care.
Read the detailed description
Sample Size and Statistical Methods:
The population of the research will consist of 199 nurses working in the surgical services and surgical intensive care units of Samsun 19 Mayıs University Faculty of Medicine Hospital between February 2024 and May 2024. The sample will consist of a total of 70 nurses (experiment = 35, control = 35) who meet the inclusion criteria for the study between the same dates. For the intervention and control groups; sampling criteria; Working as a nurse in a surgical ward or surgical intensive care unit and volunteering to participate in the study were defined as being eligible. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. As a similar study in the relevant literature, in the research conducted by Düdener (2019), the effect size regarding the difference in care behaviors was calculated as 0.647. In order to exceed the 95% value in determining the power of the study; At the 5% significance level and 0.615 effect size, 56 people, 28 people in the groups, need to be reached (df=27; t=1.703). In the research, it was aimed to reach a total of 70 people, 35 people in the groups, considering the high power of the test and the losses.
Nutrition Education Group
"Enteral and Parenteral Nutrition Training", prepared based on the literature, has been given to the nurses in the experimental group. The content of the training guide has been sent to ten experts in the field and content validity will be made. Enteral and parenteral nutrition training has been given face to face, in 15-20 minutes, using verbal presentation and written materials (brochures). "Descriptive Survey Form" will be applied to the experimental group (n=35) at the beginning of the research. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" hasbeen applied three times: before the training, within one or two days after the training and three weeks after the training.
Control group:
No intervention has been made to the nurses in the control group (n = 35). In-service training is provided to nurses in this group in the clinic. After the study is completed, written material (brochure) has been given to the nurses in the control group."Descriptive Survey Form" will be applied at the beginning of the study. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" has been applied three times as pre-test, post-test and follow-up test (three weeks later).
Data Collection Tools
"Descriptive Survey Form", "Care Behavior Scale-24 (BDI-24)" and "Knowledge Test on Enteral and Parenteral Nutritional Care" developed by the researchers were used to collect data in the study. The Knowledge Test on Enteral and Parenteral Nutritional Care was sent to ten experts along with the training guide to ensure content validity.
- Conditions
- Enteral Nutrition, Parenteral Nutrition, Nursing Care
- Being tested
- Assigned intervention
- Keywords
- EPN, Nutritional Care, Surgery, Care Behaviors
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned interventionBehavioural
Also called Enteral and Parenteral Nutrition Training
Enteral and parenteral nutrition training was given face to face, within 15-20 minutes, using oral presentation and written materials (brochures). The content of the "Enteral and Parenteral Nutrition Training Guide" prepared based on the literature was sent to ten experts in the field. and content validity was done. The training guide includes up-to-date information on topics such as enteral and parenteral nutrition indications and contraindications, evaluation of gastric residual volume, and nursing care in patients receiving enteral and parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention was made to the nurses in the control group (n = 35). In-service training is provided to nurses in this group in the clinic. After the study is completed, written material (brochure) was given to the nurses in the control group."Descriptive Survey Form" was applied at the beginning of the study. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" were applied three times as pre-test, post-test and follow-up test (three weeks later). |
| Nutrition education group | Experimental | It was planned to give "Enteral and Parenteral Nutrition Training" to the nurses in the experimental group, based on the literature. The content of the training guide was sent to ten experts in the field and content validity was made. Enteral and parenteral nutrition training was given face to face, in 15-20 minutes, using verbal presentation and written materials (brochures). "Descriptive Survey Form" was applied to the experimental group (n=35) at the beginning of the research. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" were administered three times: before the training, within one or two days of the training and three weeks after the training. Receives: Behavioral: Assigned intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Test on Enteral and Parenteral Nutritional Care
The "Knowledge Test on Enteral and Parenteral Nutritional Care (EPNB)" developed by the researchers consists of 45 items with "True" and "False" options. The content validity of the knowledge test will be carried out by ten experts in the field. In the EPNB Knowledge Test, 1 point is given for each correctly answered statement in the data set, and 0 point is given for each incorrectly answered statement. A minimum of 0 points and a maximum of 45 points in total can be obtained from the "EPNB Information Form".
Measured: one day
Secondary outcomes (1)
Care Behavior Scale-24
Caring Behaviors Scale-24 (BDI-24) was created by Wu et al. (2006). The validity and reliability study of the scale was conducted by Kurşun and Kanan (2012) in our country. The scale was designed to evaluate the nursing care process. The scale is a six-point Likert type and consists of 24 items. The minimum total score obtained from the scale is 24 and the maximum is 144. Calculation of scale scores: Obtaining the total scale score: After adding the scores of 24 items, dividing by 24, a scale score between 1 and 6 is obtained. Obtaining sub-dimensions: For each sub-dimension, sub-dimension scores between 1-6 points are obtained by adding up the scores of the items in the sub-dimensions and dividing the resulting score by the number of items.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonay GÖKTAŞ, PhD, Study director, Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234163
- Sponsor's protocol ID
- SINOPU-elif 1
- Status last verified
- May 2024
- First submitted
- 22 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enteral and Parenteral Nutrition Training Applied to Surgical Nurses on Their Knowledge Level and Care Behaviors Regarding Nutritional Care: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06234163
- Acronym / sponsor ID
- SINOPU-elif 1
- Conditions
- Enteral Nutrition, Parenteral Nutrition, Nursing Care
- Keywords
- EPN, Nutritional Care, Surgery, Care Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 31 Jan 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.
Malnutrition is considered as a deficiency of energy, protein or other nutrients. Malnutrition is a big problem for surgical patients. Various physiological problems may occur in patients with inadequate or malnutrition, such as prolonged wound healing time, decreased muscle strength and deterioration in immune system functions. It is recommended to start oral nutrition in the early postoperative period. In cases where the oral route is not preferred, enteral and parenteral nutritional support should be provided to the patient continuously or intermittently. Failure to identify individuals at risk of malnutrition means delaying the nutritional support the patient needs. Close observations and evaluations made by nurses during the day can ensure early diagnosis of the patient at risk of malnutrition and receive the necessary nutritional support. In order for nurses to fulfill their duties regarding nutritional care, they must have sufficient knowledge and skills on the subject and perceive the importance of nutritional care for patients. "Care" forms the basis of nursing. The interaction between patient and nurse affects the process and quality of care. Care behaviors include some basic skills such as listening carefully to the patient by making eye contact, empathy, demonsrating professional knowledge and skills, taking responsibility for the patient, and being accessible. In order to increase the quality of nursing care given to patients, it is necessary to provide evidence-based care and ensure that the care given is compatible with the values and expectations of the patients. For these reasons, this study aimed to examine the effect of enteral and parenteral nutrition (EPN) training on the knowledge level and care behaviors of surgical nurses regarding nutritional care.
Detailed description
Sample Size and Statistical Methods:
The population of the research will consist of 199 nurses working in the surgical services and surgical intensive care units of Samsun 19 Mayıs University Faculty of Medicine Hospital between February 2024 and May 2024. The sample will consist of a total of 70 nurses (experiment = 35, control = 35) who meet the inclusion criteria for the study between the same dates. For the intervention and control groups; sampling criteria; Working as a nurse in a surgical ward or surgical intensive care unit and volunteering to participate in the study were defined as being eligible. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. As a similar study in the relevant literature, in the research conducted by Düdener (2019), the effect size regarding the difference in care behaviors was calculated as 0.647. In order to exceed the 95% value in determining the power of the study; At the 5% significance level and 0.615 effect size, 56 people, 28 people in the groups, need to be reached (df=27; t=1.703). In the research, it was aimed to reach a total of 70 people, 35 people in the groups, considering the high power of the test and the losses.
Nutrition Education Group
"Enteral and Parenteral Nutrition Training", prepared based on the literature, has been given to the nurses in the experimental group. The content of the training guide has been sent to ten experts in the field and content validity will be made. Enteral and parenteral nutrition training has been given face to face, in 15-20 minutes, using verbal presentation and written materials (brochures). "Descriptive Survey Form" will be applied to the experimental group (n=35) at the beginning of the research. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" hasbeen applied three times: before the training, within one or two days after the training and three weeks after the training.
Control group:
No intervention has been made to the nurses in the control group (n = 35). In-service training is provided to nurses in this group in the clinic. After the study is completed, written material (brochure) has been given to the nurses in the control group."Descriptive Survey Form" will be applied at the beginning of the study. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" has been applied three times as pre-test, post-test and follow-up test (three weeks later).
Data Collection Tools
"Descriptive Survey Form", "Care Behavior Scale-24 (BDI-24)" and "Knowledge Test on Enteral and Parenteral Nutritional Care" developed by the researchers were used to collect data in the study. The Knowledge Test on Enteral and Parenteral Nutritional Care was sent to ten experts along with the training guide to ensure content validity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention was made to the nurses in the control group (n = 35). In-service training is provided to nurses in this group in the clinic. After the study is completed, written material (brochure) was given to the nurses in the control group."Descriptive Survey Form" was applied at the beginning of the study. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" were applied three times as pre-test, post-test and follow-up test (three weeks later). |
| Nutrition education group | Experimental | Behavioral: Assigned interventionIt was planned to give "Enteral and Parenteral Nutrition Training" to the nurses in the experimental group, based on the literature. The content of the training guide was sent to ten experts in the field and content validity was made. Enteral and parenteral nutrition training was given face to face, in 15-20 minutes, using verbal presentation and written materials (brochures). "Descriptive Survey Form" was applied to the experimental group (n=35) at the beginning of the research. Other measurement tools, "Enteral and Parenteral Nutrition Care Knowledge Test" and "Care Behavior Scale-24 (BDI-24)" were administered three times: before the training, within one or two days of the training and three weeks after the training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having the title of nurse
- Working in a surgical ward or surgical intensive care unit
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- filling out forms incompletely
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 |
|---|---|---|
| Assigned interventionAlso: Enteral and Parenteral Nutrition TrainingEnteral and parenteral nutrition training was given face to face, within 15-20 minutes, using oral presentation and written materials (brochures). The content of the "Enteral and Parenteral Nutrition Training Guide" prepared based on the literature was sent to ten experts in the field. and content validity was done. The training guide includes up-to-date information on topics such as enteral and parenteral nutrition indications and contraindications, evaluation of gastric residual volume, and nursing care in patients receiving enteral and parenteral nutrition. | Behavioural | Nutrition education group |
Primary outcome
Knowledge Test on Enteral and Parenteral Nutritional Care
Time frame: one day
The "Knowledge Test on Enteral and Parenteral Nutritional Care (EPNB)" developed by the researchers consists of 45 items with "True" and "False" options. The content validity of the knowledge test will be carried out by ten experts in the field. In the EPNB Knowledge Test, 1 point is given for each correctly answered statement in the data set, and 0 point is given for each incorrectly answered statement. A minimum of 0 points and a maximum of 45 points in total can be obtained from the "EPNB Information Form".
1 secondary outcome
Care Behavior Scale-24
Time frame: one day
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 16 May 2024.
- 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.
Sonay GÖKTAŞ, PhD study director
Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned intervention in people with Enteral Nutrition and Parenteral Nutrition, run by Sinop 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 3 inclusion and 1 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 16 May 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?
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?
Knowledge Test on Enteral and Parenteral Nutritional Care (time frame: one day). 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 16 May 2024.