Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT05959993

Collaborator

(none)

Enrollment

Location

Arms

28.2

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Outpatients Defibrillators, Implantable	Behavioral: Human Care Model Based Nursing Interventions	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Jan 23, 2021

Actual Study Completion Date :

Jul 7, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Increasing the patient's psychosocial adjustment with ICD [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University	İzmir	Bornova	Turkey	35040

Sponsors and Collaborators

Ege University

Investigators

Study Director: Serap Yıldırım, Associate Professor, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ozgur Demir Gayretli, Principal Investigator, Ege University

ClinicalTrials.gov Identifier:

NCT05959993

Other Study ID Numbers:

ODGayretli

First Posted:

Jul 25, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ozgur Demir Gayretli, Principal Investigator, Ege University

Defibrillator

Human Care Model

Psychosocial Adjustment

Study Results

No Results Posted as of Aug 1, 2023