Effect Of Counselıng

June 4, 2021 updated by: çiğdem kaya, Uşak University

Effect Of Counselıng on Qualıty of Lıfe and Self-Care Agency for Patıents Who Are Scheduled for Total Knee Replacement

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Uşak, Merkez, Turkey, 64000
        • Usak University Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Counseling
Quasi-experimental design. Face-to-face and telephone counseling were applied to individuals in the intervention group.
Other: Counseling
Face-to-face and telephone counseling were applied to individuals in the intervention group.
Other Names:
  • Patient education

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ckaya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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