NCT04862104

Brief Summary

A randomized control trial was made to examine the effect of discharge training developed using Nursing Interventions Classification on surgical recovery in patient who underwent oncological surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

April 23, 2021

Last Update Submit

April 27, 2021

Conditions

Keywords

Surgical recoveryDischarge TrainingFollow-upNursing

Outcome Measures

Primary Outcomes (4)

  • The surgical recovery score averages in patients

    assessed using the Patient Evaluation Form, nine defining features of the diagnosis of "delayed surgical recovery" defined in NANDA-I (delaying starting activities at home / work, understanding that more time is required for recovery/ recovery, need for assistance in self-care practices, evidence indicating impaired surgical site presence (discharge, swelling, redness, pain, presence of one of the bleeding in the area mild; the presence of all will be marked as severe distress), loss of appetite with nausea, loss of appetite without nausea, difficulty in moving around, pain or discomfort, fatigue) It contains questions. The patient evaluation form was created using the Nursing Outcomes Classification of the five-point Likert-type scale measuring the severity of descriptive features. The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no

    before discharge in the postoperative days

  • The surgical recovery status after intervention

    assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the second week after discharge.

    In the second weeks after discharge

  • The surgical recovery status after intervention

    assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the fourth week after discharge.

    In the fourth weeks after discharge

  • The surgical recovery status after intervention

    assessed using the Patient Evaluation Form. The form is composed of nine items. The form is The expression "severely distressed" was "1 point"; The expression "significantly distressed" was evaluated as "2 points", "moderately distressed" as "3 points", "mildly distressed" as "4 points", and "no distress" as "5 points". The patient can get a minimum of nine and a maximum of 45 points. As the score for each evaluation question increased, the improvement was evaluated as positive. It was applied by telephone in the eighth week after discharge.

    In the eighth weeks after discharge

Study Arms (2)

Intervention group (Discharge Training)

EXPERIMENTAL

In addition to the general care provided by health professionals, the study group received discharge training created according to the Nursing Interventions Classification.

Behavioral: Intervention group

Control group (Usual Care)

NO INTERVENTION

The control group continued to receive the routine care

Interventions

In addition to the routine care they received, the patients in the intervention groups were given discharge training developed in the pre-discharge period. Discharge training consisted of a verbal and written information booklet containing instructions for the patient and the patient's caregiver on pain management, nutrition management, incision site care, strengthening self-care, returning to daily life activities, and colostomy care. Discharge training was given in the service after evaluating the surgical recovery status of the patient before discharge. The average duration of each training was 30-45 minutes. The patients were evaluated in terms of surgical recovery by calling by phone 2 weeks after discharge, 4 weeks and 8 weeks later. The developed education booklet was given to the patient and it was ensured that he could benefit from the information at home.

Intervention group (Discharge Training)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18 and 75
  • Stomach or colorectal surgery
  • Volunteering to participate in research
  • Understanding and speaking Turkish
  • Having a telephone that can be reached by him or his caregiver

You may not qualify if:

  • Responding to less than 75% of phone calls
  • Not having cognitive functions in place
  • Having a hearing problem
  • Not having a relative to answer in case he / she cannot answer the phone
  • Having complications during hospitalization (ileus, septic shock, herniation)
  • Having a history of chemotherapy / radiotherapy in the last two months
  • To receive chemotherapy / radiotherapy within two months after surgery
  • Complications developed during surgery
  • To be transferred to the intensive care unit after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • Arslan E, Gezer N. The effect of discharge training developed based on nursing interventions classification (NIC) on surgical recovery in oncology patients: Randomized controlled trial - A pilot study. Nurs Open. 2023 Feb;10(2):1151-1162. doi: 10.1002/nop2.1555. Epub 2022 Dec 25.

Study Officials

  • Ezgi Arslan, PhD Student

    Aydın Adnan Menderes University, Faculty of Nursing, Surgical Nursing Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Following recruitment, patient who underwent oncological surgery were divided into a study and a control group by randomization (1:1 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 27, 2021

Study Start

August 1, 2018

Primary Completion

July 31, 2019

Study Completion

December 27, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations