Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

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

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.

Study Overview

• Status: Completed
• Conditions: Outpatients; Defibrillators, Implantable
• Intervention / Treatment: Behavioral: Human Care Model Based Nursing Interventions

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35040
      • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.	Behavioral: 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.
No Intervention: Control group; Control group participants were not subjected to a structured nursing intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increasing the patient's psychosocial adjustment with ICD	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.	10 week later

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Director: Serap Yıldırım, Associate Professor, Ege University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): January 23, 2021
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Defibrillator; Psychosocial Adjustment; Human Care Model
• Other Study ID Numbers: ODGayretli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No