Total Knee ReplacementNCT04916717
Effect Of Counselıng
A study testing Counseling in people with Total Knee Replacement and Quality of Life, run by Uşak University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement, Quality of Life, Nursing Caries
- What is being tested?
- Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University Education and Research Hospital
Uşak, Merkez, 64000
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Replacement, Quality of Life, Nursing Caries
- Being tested
- Counseling
- Keywords
- total knee replacement, nursing counseling, counseling, quality of life, self care agency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Patient education
Face-to-face and telephone counseling were applied to individuals in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Other | Quasi-experimental design. Face-to-face and telephone counseling were applied to individuals in the intervention group. Receives: Other: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SF-36)
in quality of life change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period)
Measured: up to 16 weeks
Self Care Agency
in self care agency change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period)
Measured: up to16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Apr 2018
- Primary completion1 Jul 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a quantitative study and has a quasi-experimental design with a control group.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, çiğdem kaya, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916717
- Sponsor's protocol ID
- ckaya
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Counselıng on Qualıty of Lıfe and Self-Care Agency for Patıents Who Are Scheduled for Total Knee Replacement
- ClinicalTrials.gov ID
- NCT04916717
- Acronym / sponsor ID
- ckaya
- Conditions
- Total Knee Replacement, Quality of Life, Nursing Caries
- Keywords
- total knee replacement, nursing counseling, counseling, quality of life, self care agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of counseling on quality of life and self-care agency for patients who are scheduled for TKR.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quantitative study and has a quasi-experimental design with a control group.
| Arm | Type | Receives |
|---|---|---|
| Counseling | Other | Other: CounselingQuasi-experimental design. Face-to-face and telephone counseling were applied to individuals in the intervention group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Patient educationFace-to-face and telephone counseling were applied to individuals in the intervention group. | Other | Counseling |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Total Knee Replacement and Quality of Life, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (SF-36) (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.