- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06453655
The Effect of Nurse Process on Bowel Cleansing
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Hacettepe Uviversity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- They had suspected or diagnosed colorectal cancer
- Previous colon surgery,
- Emergency colonoscopy
- Pregnancy
- Breastfeeding
- Diagnosed mental illness
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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
|
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.
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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
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3 days after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NOC-1 Knowledge: Prescribed Diet (1802)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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
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7 days before and on the day of the colonoscopy procedure
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NOC-2 Knowledge: Medication (1808)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-3 Compliance Behavior-Prescribed Diet (1622)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-4 Compliance Behavior-Prescribed Medication (1623)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-5 Anxiety Level (1211)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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
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7 days before and on the day of the colonoscopy procedure
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NOC-6 Communication (0902)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-7 Skin Integrity: Skin Mucous Membranes (1101)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-8 Comfort Status Physical (2010)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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NOC-9 Sleep (0004)
Time Frame: 7 days before and on the day of the colonoscopy procedure
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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.
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7 days before and on the day of the colonoscopy procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Humeyra Zengin, RN, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUNP170977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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