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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

Primary Purpose

Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training and Follow-up According to the Neuman Systems Model
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring nurse, oral Mucositis, education

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • Atatürk university nursing facultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Training and Follow-up According to the Neuman Systems Model

only procedure will be applied

Outcomes

Primary Outcome Measures

Comfort Perception Scale in Oral Mucositis
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.
Oral Mucositis Grading Index:
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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2023
Last Updated
August 12, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05991544
Brief Title
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
Official Title
The Effect of Training and Follow-up Given to Cancer Patients Receiving Chemotherapy According to the Neuman Systems Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
nurse, oral Mucositis, education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Training and Follow-up According to the Neuman Systems Model
Arm Title
Control
Arm Type
No Intervention
Arm Description
only procedure will be applied
Intervention Type
Behavioral
Intervention Name(s)
Training and Follow-up According to the Neuman Systems Model
Intervention Description
Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables
Primary Outcome Measure Information:
Title
Comfort Perception Scale in Oral Mucositis
Description
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.
Time Frame
12 week
Title
Oral Mucositis Grading Index:
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülcan B.TURAN
Phone
05065576086
Email
glcnbah@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin Erdem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan B.TURAN
Organizational Affiliation
Firat University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasemin Erdem
Organizational Affiliation
Erzurum Technical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seda Karaman
Organizational Affiliation
Atatatürk Üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk university nursing faculty
City
Erzurum
State/Province
Center
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin Erdem

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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