Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

NCT05959993 | Completed DMC

• 1 other identifier: ODGayretli
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Outpatients; Defibrillators, Implantable

Keywords

Defibrillator; Human Care Model; Psychosocial Adjustment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Study Officials

• Serap Yıldırım, Associate Professor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 25, 2023
• Study Start: March 1, 2020
• Primary Completion: January 23, 2021
• Study Completion: July 7, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)