NCT06453655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

May 30, 2024

Last Update Submit

June 5, 2024

Conditions

Keywords

Nursing ProcessStandard Nursing TerminologiesNANDA-I DiagnosesNursing InterventionNursing Outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • NOC-1 Knowledge: Prescribed Diet (1802)

    7 days before and on the day of the colonoscopy procedure

  • NOC-2 Knowledge: Medication (1808)

    7 days before and on the day of the colonoscopy procedure

  • NOC-3 Compliance Behavior-Prescribed Diet (1622)

    7 days before and on the day of the colonoscopy procedure

  • NOC-4 Compliance Behavior-Prescribed Medication (1623)

    7 days before and on the day of the colonoscopy procedure

  • NOC-5 Anxiety Level (1211)

    7 days before and on the day of the colonoscopy procedure

  • +4 more secondary outcomes

Study Arms (2)

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

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.

Interventions

Nursing ProcessBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Uviversity

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nursing Process

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Humeyra Zengin, RN, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Experienced endoscopists, who were unaware of the instructions given to the subjects, performed the colonoscopies. The endoscopist who performed the procedure added the visual assessment score to the patient's colonoscopy report, regardless of their participation in the study.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nursing Services

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 11, 2024

Study Start

December 30, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations