Defibrillators, Implantable Clinical Trial
Official title:
The Effect of Human Care Model-Based Nursing Interventions on Psychosocial Adjustment in Patients With Cardioverter Defibrillator
NCT number | NCT05959993 |
Other study ID # | ODGayretli |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | July 7, 2022 |
Verified date | July 2023 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | July 7, 2022 |
Est. primary completion date | January 23, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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