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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06453655
Other study ID # HUNP170977
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2018
Est. completion date May 31, 2019

Study information

Verified date June 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Intervention

Behavioral:
Nursing Process
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.

Locations

Country Name City State
Turkey Hacettepe Uviversity Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 days after the procedure
Secondary 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 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
Secondary 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. 7 days before and on the day of the colonoscopy procedure
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