Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

NCT ID: NCT05959993

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-07-07

Brief Summary

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The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.

Detailed Description

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Aim: The aim of this research was to investigate the impact of nursing interventions that were Watson's Human Care Model- based nursing interventions on the psychosocial adjustment of patients who have undergone implantable cardioverter defibrillator (ICD) implantation.

Design: The present study employs a randomized controlled design with a pretest-posttest control group, conducted over a period spanning from March 2020 to July 2022.

Methods: The research was carried out utilizing an implantable cardioverter on individuals who met the inclusion criteria and provided consent to participate in the study at an adult cardiology outpatient unit located within a university hospital. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. The data were gathered utilizing an introductory information form and the Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR). The statistical methods employed in the data analysis included the chi-square test, t test for independent groups, Mann-Whitney U test, t test for dependent groups, and Wilcoxon signed-rank test.

Conditions

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Outpatients Defibrillators, Implantable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.

Group Type EXPERIMENTAL

Human Care Model Based Nursing Interventions

Intervention Type BEHAVIORAL

The interviews scheduled for the intervention group were organized in accordance with the sub-dimensions of the PAIS-SR scale, and the content of each interview was informed by the 10 improvement processes of HCT.

Control group

Control group participants were not subjected to a structured nursing intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Human Care Model Based Nursing Interventions

The interviews scheduled for the intervention group were organized in accordance with the sub-dimensions of the PAIS-SR scale, and the content of each interview was informed by the 10 improvement processes of HCT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* the patient must be of legal age
* the patient must have undergone ICD implantation at least one month prior
* the patient must possess the ability to comprehend and communicate in Turkish
* the patient must not exhibit any hearing or speech impairments
* the patient must not have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
* the patient must possess the capability to operate a computer, telephone, and internet

Exclusion Criteria

* the patient is less than 18 years old
* the patient has hearing and speech problems
* the patient must have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
* the patient must not possess the capability to operate a computer, telephone, and internet
* the patient's refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ozgur Demir Gayretli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serap Yıldırım, Associate Professor

Role: STUDY_DIRECTOR

Ege University

Locations

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Ege University

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ODGayretli

Identifier Type: -

Identifier Source: org_study_id

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