Colorectal CancerNCT06453655
The Effect of Nurse Process on Bowel Cleansing
A study testing Nursing Process in people with Colorectal Cancer and Colonoscopy Preparation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is still the gold standard method for the diagnosis and treatment of colon cancers. Preparation for colonoscopy is a complex processa (eg. restricted diet three days before the procedure and to drink large volumes of drog ) involving many steps. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colonoscopy Preparation, Boston Bowel Preparation Scale
- What is being tested?
- Nursing Process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2018to 31 May 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 to 70 years,
- Outpatients admitted to the Gastroenterology Department and Endoscopy Unit of Hacettepe University Adult Hospital
- First-time colonoscopy screening patients,
- Patients who agreed to participate in the study by signing informed consent one week before the appointment
Who cannot join
- They had suspected or diagnosed colorectal cancer
- Previous colon surgery,
- Emergency colonoscopy
- Pregnancy
- Breastfeeding
- Diagnosed mental illness
Show all 14Show fewer
- Class 3-4 heart failure,
- Patients with hearing problems
- Chronic renal failure requiring dialysis
- A family member undergoing colonoscopy at the same time
- Muscle weakness due to cerebrovascular disease, or hemiplegia/plegia
- People who wanted to leave the study during the research
- Those who are simultaneously included in the working groups due to family affinity
- Those who cannot complete the colonoscopy procedure for various reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nursing Process Using Standard Nursing Terminologies in Colonoscopy Preparation of Outpatients on Bowel Cleansing
Colonoscopy is still the gold standard method for the diagnosis and treatment of colon cancers. Preparation for colonoscopy is a complex processa (eg. restricted diet three days before the procedure and to drink large volumes of drog ) involving many steps. It has been shown that the symptoms experienced by patients during colonoscopy preparation have an impact on the quality of the colonoscopy procedure. Adequate bowel preparation is essential for successful colonoscopy imaging and to detect and remove existing polyps. aim of this study was to examine the effect of the nursing process applied by using standard nursing terminologies on colonoscopy preparation of outpatients on bowel cleansing.
This study was designed as a prospective, single-blind, randomized controlled trial. This study tested the hypothesis that the nursing process using thestandard nursing terminologies NANDA-I, NIC and NOC for colonoscopy preparation has an effect on adequate bowel cleansing.
Read the detailed description
Nurses use standardized nursing language (SNL) to address complex relationships between presenting problems and individuals from a holistic perspective. The most widely used nursing diagnosis classification worldwide is NANDA-I, which includes nursing outcomes and interventions, respectively. In this study, after determining the nursing diagnosis specific to the colonoscopy procedure (NANDA-I), we evaluated which nursing outcomes (NOC) were appropriate for the patient's condition and then selected the nursing interventions (NIC) with the highest probability of achieving the desired outcome and implemented a nursing process. The study was conducted as a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized into two groups. Both groups received verbal and written instructions according to standard care, while the intervention group received a nursing process. After the interview, NANDA-I diagnoses were determined according to the needs of the individuals, and NOC scales appropriate to these diagnoses were selected and NOCs were first evaluated. According to the prepared nursing care plan, the nursing interventions selected in accordance with the diagnoses were reminded to the patients by phone and their compliance with the colonoscopy preparation instructions was monitored. When the patient came to the hospital for colonoscopy, face-to-face interviews were conducted, and final evaluations of NOC scales were performed. Primary outcomes included bowel preparation scores graded using the Boston Bowel Preparation Score (BBPS) and secondary outcomes included scores on NOCs selected according to the process of preparation for the colonoscopy procedure.
- Being tested
- Nursing Process
- Keywords
- Nursing Process, Standard Nursing Terminologies, NANDA-I Diagnoses, Nursing Intervention, Nursing Outcome
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing ProcessBehavioural
In the first step of the nursing process, nursing diagnoses NANDA-I and nursing outcomes (NOC) appropriate to the needs of the individual were selected. Immediately afterwards, the baseline measurements of NOCs were made. In the second stage, nursing interventions were determined in line with the selected diagnoses and started to be implemented. Instructions for the implementation of the selected NICs were reminded by phone 3 days before the procedure appointment and compliance with colonoscopy preparation instructions was monitored. In the third stage, after measurement of the NOCs were performed on the day of the procedure. In addition, the BBPS scores calculated by the endoscopist during the procedure were taken from the patient file and recorded in the data collection form and the stages of the nursing process were completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group was interviewed face to face one week before the day of the procedure and the nursing process was started to be applied. In the 3-day period before the procedure, the nursing process was continued with daily telephone follow-up. In the first face-to-face interview, nursing diagnoses and nursing outcome scales appropriate to the needs of the individual were determined and NOCs baseline measurements were made. NICs selected according to the nursing process were applied for 7 days. The last measurement of NOCs was made on the day of the procedure. In addition, BBPS scores calculated by the endoscopist during the procedure were taken from the patient file and recorded in the data collection form Receives: Behavioral: Nursing Process |
| Control Group | No intervention | This grup nursing diagnoses and expected nursing outcomes (NOC) appropriate to the needs of the individual were selected in a face-to-face interview 1 week before the procedure. The baseline measurements of NOCs were made. On the trading day, the after measurement of NOCs was made. But nursing process was not applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS) score for adequacy of bowel cleansing in all segments (0-2 points for each segment), mean and percentage of total (0-9) scores
The BBPS scale was used in this study to visually evaluate all parts of the bowel (right, transverse, and left colon). On this scale, 9 points indicate excellent cleaning, and 0 points indicate inadequate bowel cleaning. According to BBPS, bowel cleansing is adequate if the score value for each segment is ≥ 2 points and above and the total score for all segments is ≥ 6 points and above. BBPS score <6 indicates inadequate bowel preparation. This scale has been used in the center where the study was conducted, and endoscopists indicate the results of the scale in writing in the colonoscopy procedure reports.BBPS scores calculated by the endoscopist during the procedure were recorded in the digital patient file. After the digital reports were approved by the relevant physician within 3 days after the procedure, the BBPS score in the patient file was included in the data collection form
Measured: 3 days after the procedure
Secondary outcomes (9)
NOC-1 Knowledge: Prescribed Diet (1802)
The level of understanding of information about the diet recommended by a health professional for a specific health condition (14 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-2 Knowledge: Medication (1808)
The level of understanding of the information conveyed about a particular treatment regimen (13 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-3 Compliance Behavior-Prescribed Diet (1622)
Personal actions to follow the food and fluid intake recommended by a health professional for a specific health condition (11 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-4 Compliance Behavior-Prescribed Medication (1623)
Personal actions to safely administer a medicinal product as recommended by healthcare professionals to take full advantage of the therapeutic effects specific to a particular condition (13 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-5 Anxiety Level (1211)
Level of severity of anxiety, stress or uneasiness caused by an unidentified cause (13 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-6 Communication (0902)
Express, receive and interpret verbal, written and non-verbal messages (11 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-7 Skin Integrity: Skin Mucous Membranes (1101)
Unpleasant sensory and emotional experience arising from actual or potential or described tissue injury, with sudden or slow onset of mild to severe intensity, constant or recurrent, without an anticipated or predictable termination (5 items were evaluated). Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-8 Comfort Status Physical (2010)
Physical comfort with body sensations and homeostatic mechanisms (13 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
NOC-9 Sleep (0004)
Returning to the natural periodic pattern of the body's regeneration ( 11 items were evaluated) Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 7 days before and on the day of the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start30 Dec 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humeyra Zengin, RN,PhD, Hacettepe University
- Investigators
- Humeyra Zengin, RN, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453655
- Sponsor's protocol ID
- HUNP170977
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Process Using Standard Nursing Terminologies in Colonoscopy Preparation of Outpatients on Bowel Cleansing
- ClinicalTrials.gov ID
- NCT06453655
- Acronym / sponsor ID
- HUNP170977
- Keywords
- Nursing Process, Standard Nursing Terminologies, NANDA-I Diagnoses, Nursing Intervention, Nursing Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 11 Jun 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.
Colonoscopy is still the gold standard method for the diagnosis and treatment of colon cancers. Preparation for colonoscopy is a complex processa (eg. restricted diet three days before the procedure and to drink large volumes of drog ) involving many steps. It has been shown that the symptoms experienced by patients during colonoscopy preparation have an impact on the quality of the colonoscopy procedure. Adequate bowel preparation is essential for successful colonoscopy imaging and to detect and remove existing polyps. aim of this study was to examine the effect of the nursing process applied by using standard nursing terminologies on colonoscopy preparation of outpatients on bowel cleansing.
This study was designed as a prospective, single-blind, randomized controlled trial. This study tested the hypothesis that the nursing process using thestandard nursing terminologies NANDA-I, NIC and NOC for colonoscopy preparation has an effect on adequate bowel cleansing.
Detailed description
Nurses use standardized nursing language (SNL) to address complex relationships between presenting problems and individuals from a holistic perspective. The most widely used nursing diagnosis classification worldwide is NANDA-I, which includes nursing outcomes and interventions, respectively. In this study, after determining the nursing diagnosis specific to the colonoscopy procedure (NANDA-I), we evaluated which nursing outcomes (NOC) were appropriate for the patient's condition and then selected the nursing interventions (NIC) with the highest probability of achieving the desired outcome and implemented a nursing process. The study was conducted as a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized into two groups. Both groups received verbal and written instructions according to standard care, while the intervention group received a nursing process. After the interview, NANDA-I diagnoses were determined according to the needs of the individuals, and NOC scales appropriate to these diagnoses were selected and NOCs were first evaluated. According to the prepared nursing care plan, the nursing interventions selected in accordance with the diagnoses were reminded to the patients by phone and their compliance with the colonoscopy preparation instructions was monitored. When the patient came to the hospital for colonoscopy, face-to-face interviews were conducted, and final evaluations of NOC scales were performed. Primary outcomes included bowel preparation scores graded using the Boston Bowel Preparation Score (BBPS) and secondary outcomes included scores on NOCs selected according to the process of preparation for the colonoscopy procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nursing ProcessThis group was interviewed face to face one week before the day of the procedure and the nursing process was started to be applied. In the 3-day period before the procedure, the nursing process was continued with daily telephone follow-up. In the first face-to-face interview, nursing diagnoses and nursing outcome scales appropriate to the needs of the individual were determined and NOCs baseline measurements were made. NICs selected according to the nursing process were applied for 7 days. The last measurement of NOCs was made on the day of the procedure. In addition, BBPS scores calculated by the endoscopist during the procedure were taken from the patient file and recorded in the data collection form |
| Control Group | No intervention | –This grup nursing diagnoses and expected nursing outcomes (NOC) appropriate to the needs of the individual were selected in a face-to-face interview 1 week before the procedure. The baseline measurements of NOCs were made. On the trading day, the after measurement of NOCs was made. But nursing process was not applied to this group. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50 to 70 years,
- Outpatients admitted to the Gastroenterology Department and Endoscopy Unit of Hacettepe University Adult Hospital
- First-time colonoscopy screening patients,
- Patients who agreed to participate in the study by signing informed consent one week before the appointment
Key exclusion criteria (14 listed)
- They had suspected or diagnosed colorectal cancer
- Previous colon surgery,
- Emergency colonoscopy
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| Nursing ProcessIn the first step of the nursing process, nursing diagnoses NANDA-I and nursing outcomes (NOC) appropriate to the needs of the individual were selected. Immediately afterwards, the baseline measurements of NOCs were made. In the second stage, nursing interventions were determined in line with the selected diagnoses and started to be implemented. Instructions for the implementation of the selected NICs were reminded by phone 3 days before the procedure appointment and compliance with colonoscopy preparation instructions was monitored. In the third stage, after measurement of the NOCs were performed on the day of the procedure. In addition, the BBPS scores calculated by the endoscopist during the procedure were taken from the patient file and recorded in the data collection form and the stages of the nursing process were completed. | Behavioural | Intervention |
Primary outcome
Boston Bowel Preparation Scale (BBPS) score for adequacy of bowel cleansing in all segments (0-2 points for each segment), mean and percentage of total (0-9) scores
Time frame: 3 days after the procedure
The BBPS scale was used in this study to visually evaluate all parts of the bowel (right, transverse, and left colon). On this scale, 9 points indicate excellent cleaning, and 0 points indicate inadequate bowel cleaning. According to BBPS, bowel cleansing is adequate if the score value for each segment is ≥ 2 points and above and the total score for all segments is ≥ 6 points and above. BBPS score <6 indicates inadequate bowel preparation. This scale has been used in the center where the study was conducted, and endoscopists indicate the results of the scale in writing in the colonoscopy procedure reports.BBPS scores calculated by the endoscopist during the procedure were recorded in the digital patient file. After the digital reports were approved by the relevant physician within 3 days after the procedure, the BBPS score in the patient file was included in the data collection form
9 secondary outcomes
NOC-1 Knowledge: Prescribed Diet (1802)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-2 Knowledge: Medication (1808)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-3 Compliance Behavior-Prescribed Diet (1622)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-4 Compliance Behavior-Prescribed Medication (1623)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-5 Anxiety Level (1211)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-6 Communication (0902)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-7 Skin Integrity: Skin Mucous Membranes (1101)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-8 Comfort Status Physical (2010)
Time frame: 7 days before and on the day of the colonoscopy procedure
NOC-9 Sleep (0004)
Time frame: 7 days before and on the day of the colonoscopy procedure
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 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 2
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Ras-mutated Metastatic Colorectal Cancer, mCRC
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.
Humeyra Zengin, RN, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Process in people with Colorectal Cancer and Colonoscopy Preparation, run by Hacettepe 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 14 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 11 Jun 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?
Boston Bowel Preparation Scale (BBPS) score for adequacy of bowel cleansing in all segments (0-2 points for each segment), mean and percentage of total (0-9) scores (time frame: 3 days after the procedure). 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 11 Jun 2024.