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

NCT05991544 | Unknown

• 1 other identifier: B.30.2.ATA
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

nurse; oral Mucositis; education

Outcome Measures

Primary Outcomes (2)

• 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.

  12 week

• 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.

  12 week

Study Arms (2)

Experimental

EXPERIMENTAL

Training and Follow-up According to the Neuman Systems Model

Behavioral: Training and Follow-up According to the Neuman Systems Model

Control

NO INTERVENTION

only procedure will be applied

Interventions

Training and Follow-up According to the Neuman Systems Model BEHAVIORAL

Neuman Systems Model (NSM) it presents a holistic approach to patients by including physiological, spiritual, sociocultural and five major developmental variables

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• lack of internet illiteracy

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk university nursing faculty

Erzurum, Center, 25240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gülcan B.TURAN

  Firat University

  PRINCIPAL INVESTIGATOR

• Yasemin Erdem

  Erzurum Technical University

  PRINCIPAL INVESTIGATOR

• Seda Karaman

  Atatatürk Üniversitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülcan B.TURAN

CONTACT

05065576086; glcnbah@hotmail.com

Yasemin Erdem

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)