The Effect of the Tidal Model in Diabetes Patients

NCT ID: NCT05994651

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2023-09-10

Brief Summary

Aim:

In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.

Detailed Description

Population of the Research: The population of the research will be individuals who applied to Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of the research: The sample of the research is; In calculating the number of samples, the study of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was taken as reference.At the end of the Tidal Model application, the effect size was calculated as 0.652 based on the difference between the self-esteem scores. In this context; A power of 0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to take a total of 60 individuals, with a sample size of 30 individuals in the intervention and control groups. Sample size is based on independent t-test. It was decided to include more than 20% of the sample number calculated in terms of losses during the implementation of the study and statistical analysis. Accordingly, 36 intervention and 36 control groups will beResearch data

Literature-based Personal Information Form will be collected using Diabetes Distress Scale Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written permission from the institution and written permission from the participants were obtained.In the study, in which the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10 individual interviews will be held with the individuals in the experimental group in addition to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The control group will continue to receive routine treatment and follow-up. In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the objectives of the research. Considering the basic processes of the Tidal Model, stages of care, basic approach and Tidal competencies, an interview plan including the details of the interviews with diabetes patients will be created and a meeting plan will be made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews, depending on the situation of the individuals. tried to be formed. The number of samples was calculated in the G*Power 3.1 program.

Conditions

Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tidal Model improvement model

In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives.

Group Type: EXPERIMENTAL

Tidal Model improvement model

Intervention Type: BEHAVIORAL

1. st interview Pre-assessment Application of measurement tools

2. nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions

4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process

Tidal Model Control Group

Individuals in the control group will continue their lives.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tidal Model improvement model

1. st interview Pre-assessment Application of measurement tools

2. nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions

4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.

Exclusion Criteria

Patients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Osmaniye Korkut Ata University

OTHER

Sponsor Role: lead

Responsible Party

Ejdane Coskun

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ejdane Coşkun

Role: PRINCIPAL_INVESTIGATOR

Korkut Ata University Osmaniye, Center, Türkiye, 80000

Ayşe İNEL MANAV

Role: PRINCIPAL_INVESTIGATOR

Korkut Ata University Osmaniye, Center, Türkiye, 80000

Derya Atik

Role: PRINCIPAL_INVESTIGATOR

Korkut Ata University Osmaniye, Center, Türkiye, 80000

Locations

Türkiye

Osmaniye, Korkut Ata University, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Tidal Model

Identifier Type: -

Identifier Source: org_study_id