Clinical trial NCT05994651: The Effect of the Tidal Model in Diabetes Patients
Official title: Evaluation of the Effect of Tidal Model on Distress, Self-Management and Psychological Well-Being in Individuals With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic
Keywords: Diabetes disease
Psychiatric Nursing
Tidal Model
Psychological well-being
Distress
Self-Management
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.
timeFrame: up to 6-10 weeks
measure: The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.
timeFrame: up to 6-10 weeks
measure: The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.
timeFrame: up to 6-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Türkiye
state: Korkut Ata University
Study officials:
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Ejdane Coşkun
role: PRINCIPAL_INVESTIGATOR
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Ayşe İNEL MANAV
role: PRINCIPAL_INVESTIGATOR
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Derya Atik
role: PRINCIPAL_INVESTIGATOR
References: