The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model on the Development of Oral Mucositis and Perceptions of Comfort in Patients

January 30, 2024 updated by: Gülcan Bahçecioğlu Turan, Ataturk University

The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model

It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral mucositis is a health problem that is commonly seen in patients receiving chemotherapy and radiotherapy, which seriously affects the quality of life and comfort of patients. In the literature, the importance of nursing education in supporting patients has been emphasized, as well as controlling the side effects in patients receiving chemotherapy and systematically evaluating the side effects. The training program to be planned in this context will increase the self-efficacy of patients and their ability to cope with the disease. Studies have shown that planned health education effectively supports knowledge, increases participation in treatment processes, and reduces anxiety. Nurses use various nursing interventions such as coaching, face-to-face education programs, telephone monitoring and home care while providing training in symptom management.

Theories and models in nursing include a set of ideas about people, health-illness, and society that will guide the care of patients.

Nurses can be successful in providing holistic care only through the use of nursing models. By using these models, nursing activities are shifting from service-oriented to patient-oriented service. In addition, the basic concepts and relations between the concepts are determined, problems are defined and solutions can be developed. Neuman Systems Model (NSM), one of these models, adopts the open system approach and the concept of holistic maintenance. The model, whose reliability and scientific aspect has been tried since the day it emerged, has contributed to nursing practices and systematized the nursing care plan. NSM offers a holistic approach to patients by including psychological, physiological, spiritual, sociocultural and five major developmental variables of the individual.

Therefore, it is a suitable model to be used for nursing practices. In this study, NSM will be used in order to evaluate patients holistically and to meet their needs during the treatment process. With the planned training and follow-up to be given to cancer patients receiving chemotherapy, the patients were followed closely for 3 months, and it will provide significant benefits both for the patient and the country's economy by monitoring the development of oral mucositis or providing the management of developing oral mucositis. By preventing the development of oral mucositis, patients will have a more comfortable process and will contribute to the country's economy by preventing hospitalizations. Because oral mucositis causes pain enough to require the use of narcotic drugs and increases the need for total parenteral nutrition. This situation increases the hospital costs and harms the country's economy. The fact that oral mucositis does not develop during the chemotherapy process will allow the treatment process to be comfortable and more effective for the patient.In the light of all this information; It is aimed to prevent the development of oral mucositis or to reduce the severity of developing oral mucositis with the training to be given to patients receiving chemotherapy according to the Neuman systems model. In this direction, it is thought that the study will make a serious contribution to the literature.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yasemin Erdem

Study Locations

  • Turkey
    • Center
      • Erzurum, Center, Turkey, 25240
        • Recruiting
        • Atatürk university nursing faculty
        • Contact:
          • Yasemin Erdem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Receiving chemotherapy treatment No mental or communication problems, Volunteering to participate in research. having internet, Having at least primary education level, Being able to use smart phone and internet. Being on treatment that causes methotrexate, Cispilatin, Cyclophoshamide, 5-fluorouracil group oral mucositis.

-

Exclusion Criteria:

lack of internet illiteracy

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
only procedure will be applied
Experimental: Experimental
Training and Follow-up According to the Neuman Systems Model
Behavioral: Training and Follow-up According to the Neuman Systems Model
Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort Perception Scale in Oral Mucositis
Time Frame: 12 week
The scale was developed in 2019 by Erden and İpek Çoban to evaluate the perception of comfort in patients with oral mucositis. The scale consists of 31 items and 2 sub-dimensions.
12 week
Oral Mucositis Grading Index:
Time Frame: 12 week

Developed by the World Health Organization and

It is a staging scale. Grade 0: No symptoms. Grade 1: Pain or erythema. Grade 2: Painful, erythema, edema or ulcer present, but the patient can take solid foods. Grade 3:

There is pain, erythema, edema or ulcer, the patient can only take liquid foods. Grade 4: No feeding.
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Gülcan B.TURAN, Firat University
  • Principal Investigator: Yasemin Erdem, Erzurum Technical University
  • Principal Investigator: Seda Karaman, Atatatürk Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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