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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06076746
Other study ID # 2022-1081
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date October 2024

Study information

Verified date February 2024
Source Ankara Yildirim Beyazit University
Contact Tugba Askan, PhD Student
Phone 0312 552 60 00
Email tgbskn14@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis ineffective coping. For this purpose, validity and reliability studies of the assessment tools will be carried out initially, and then a randomized controlled study will be conducted.


Description:

This study aims to evaluate the efficacy of the psychotherapeutic intervention model in nursing on patients with nursing diagnosis of ineffective coping (International Classification of Nursing Practices (ICNP)/North American Nursing Diagnostic Association (NANDA)). For this purpose, first of all, validity and reliability studies of "Coping" and "Self-Esteem", which are the results of NOC (Nursing Outcomes Classification), will be conducted, and then a randomized controlled study will be conducted (Turkish version). 200 patients will be included in the validity and reliability phase of the study, which was conducted in a hospital outpatient psychiatric setting in Turkey. The randomized controlled second phase will be carried out, single-blind, nurse-led, with approximately 26 patients with anxiety randomized to intervention (n=13) or control groups (n=13). The usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - 18-64 years old, - Literacy, - Having applied to the psychiatry outpatient clinic, - Being regularly treated in a psychiatry outpatient clinic, - Having a medical diagnosis of generalized anxiety disorder, - Having at least one of the defining characteristics of the nursing diagnosis of ineffective coping according to the nursing process. Exclusion Criteria: - Medical diagnosis of dementia or psychotic spectrum disorder, - Cognitive disorder, - Confused state of consciousness - Psychomotor agitation, - Moderate or severe intellectual disability - Expressing suicidal thoughts - Suicide attempt in the last month - Continuing psychological counseling at the moment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
NIC Psychotherapeutic Intervention(s) for Ineffective Coping
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
psychotherapeutic intervention
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University Ankara Çubuk

Sponsors (1)

Lead Sponsor Collaborator
Tugba Askan

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coping Nursing Outcomes Classification (Coping (1302)) The scale consists of 19 items. A minimum of 19 and a maximum of 95 points can be obtained from the scale. Increasing scale scores indicate good results. Baseline and through study completion, an average of 9 weeks
Primary Self esteem Nursing Outcomes Classification (Self-Esteem (1205)) The scale consists of 20 items. A minimum of 20 and a maximum of 100 points can be obtained from the scale. An increase in scale scores indicates good results. Baseline and through study completion, an average of 9 weeks
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