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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04916717
Other study ID # ckaya
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 31, 2019

Study information

Verified date June 2021
Source Usak University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the effect of counseling on quality of life and self-care agency for patients who are scheduled for TKR.


Description:

This is a quantitative study and has a quasi-experimental design with a control group. The sample of the study consisted of 79 patients including intervention (n=39) and control (n=40). The data are collected by the face-to-face interview method using Patient Identification Form, Quality of Life Scale, and Self-Care Agency Scale before surgery, and 6-8th weeks after discharge. Face-to-face and telephone counseling were applied to individuals in the intervention group. The x2, t-test, one-factor variance analysis, and two-factor variance analysis were used in the analysis of the data.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 31, 2019
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - undergoing TKA for the first time, being scheduled to have unilateral TKA, having surgery for osteoarthritis, having no postoperative complications, fulfilment of discharge criteria after surgery, being aged 18 years or older, being conscious, orientation to place and time, having no hearing or speech problems, ability to understand and speak Turkish, being at least literate, not being diagnosed with any psychiatric diseases and not having a history of cancer. Exclusion Criteria: - diagnoses of neurological (e.g. Alzheimer's disease) and psychiatric disorders (e.g. schizophrenia) likely to affect cognitive functions, first accepting to participate in the study and then dropping out of the study, development of complications during follow-up (e.g. infection), unavailability when called and lost to follow-up.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Counseling
Face-to-face and telephone counseling were applied to individuals in the intervention group.

Locations

Country Name City State
Turkey Usak University Education and Research Hospital Usak Merkez

Sponsors (1)

Lead Sponsor Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life (SF-36) in quality of life change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period) up to 16 weeks
Primary Self Care Agency in self care agency change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period) up to16 weeks
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