Clinical trial NCT05959993: Human Care Model-Based Nursing Interventions on Psychosocial Adjustment
Official title: The Effect of Human Care Model-Based Nursing Interventions on Psychosocial Adjustment in Patients With Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatients
Defibrillators, Implantable
Keywords: Defibrillator
Human Care Model
Psychosocial Adjustment
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 64
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: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increasing the patient's psychosocial adjustment with ICD
timeFrame: 10 week later
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University
name: Serap Yıldırım, Associate Professor
role: STUDY_DIRECTOR
References: