Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Outpatients Defibrillators, Implantable

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Care Model Based Nursing Interventions

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.

Primary outcomes

Increasing the patient's psychosocial adjustment with ICD

Time frame: 10 week later

Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR) scale was used. This scale is a multidimensional scale that evaluates psychosocial adjustment to the disease. There are 7 different subscales of the scale that enable the determination of psychosocial adjustment, and the scale consists of a total of 46 items. These subscales are as follows; Orientation to Healthcare, Vocational Environment, Domestic Environment, Sexual Relationships, Extended family Relationships, Social Environment and Psychological distress. The minimum and maximum scores obtained from the scale are between 0-138. The higher the score, the worse the fit. Scores below 35 from the scale indicate good psychosocial adjustment, scores between 35-51 indicate moderately good psychosocial adjustment, and scores above 51 indicate poor adjustment.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Human Care Model-Based Nursing Interventions on Psychosocial Adjustment in Patients With Cardioverter Defibrillator

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Jul 25, 2023
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed