Arthroplasty, Knee ReplacementNCT06393075
The Effectiveness of Combined Care for Knee Replacement Patients
A study testing combined care guidance and general care guidance in people with Arthroplasty, Knee Replacement, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to compare the effectiveness of combined care guidance and general care guidance on pain scores, anxiety levels and joint mobility in patients undergoing total artificial knee replacement. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthroplasty, Knee Replacement
- What is being tested?
- combined care guidance and general care guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to 30 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are 20 years old or above (inclusive), have undergone unilateral total knee replacement for the first time, have clear consciousness, can speak Mandarin and Taiwanese, have elementary school-level reading ability, and are willing to participate in the study
Who cannot join
- Patients with bilateral total knee replacement, osteoarthritis tumors, rheumatoid arthritis, who are unable to cooperate with interventional measures, patients with dementia or cognitive dysfunction who are unable to cooperate; those who are participating in other pain control studies
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Veterans General Hospital
Taipei, 112
LI YING-HUNG, 32, 0911887897, yhlee12@vghtpe.gov.tw
About this study
Official title: Effect of Preoperative Combined Care Guidance on Pain, Anxiety and Joint Range of Motion in Patients Undergoing Total Knee Arthroplasty
The goal of this clinical trial is to compare the effectiveness of combined care guidance and general care guidance on pain scores, anxiety levels and joint mobility in patients undergoing total artificial knee replacement. The main questions it aims to answer are:
- Does combined care coaching reduce patient pain scores and anxiety levels after surgery?
- Does combined care guidance improve knee joint mobility after surgery? Researchers will compare combined care guidance and general care to see if combined care guidance reduces patients' pain scores and anxiety levels after surgery, and improves knee joint mobility after surgery.
Read more
Participants will:
- Watch pain and rehabilitation exercise guidance videos before surgery and learn how to use a walker.
- Complete questionnaires before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.
- Questionnaire records pain level, anxiety level and joint mobility.
Read the detailed description
Background:The population is aging rapidly, and an aging society is approaching. According to Taiwan government statistics, the population over 65 years old has reached 16.2%. The number of people suffering from knee osteoarthritis has reached 860,000, and the number of patients undergoing total artificial knee replacement has reached 29,000. people.Artificial knee replacement can effectively relieve joint pain, correct joint deformities, and improve joint function. However, patients who undergo total artificial knee replacement still experience moderate to severe pain after surgery. Effective pain control can promote early rehabilitation and early ambulation of patients. In clinical practice, it is more common to provide a single interventional measure to improve the pain level after surgery, but less to provide combined measures before surgery, which leads to the motivation for discussion.
Purpose:To compare the effectiveness of combined care guidance and general care Method:guidance on pain scores, anxiety levels and joint mobility of patients undergoing total artificial knee replacement before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.Experimental group: Researchers provided combined care, watched animated videos, demonstrated rehabilitation exercises and practiced walking using walkers.Control group: The researchers provided general preoperative care and demonstrated rehabilitation exercises and the use of walking aids after surgery.
:This study adopted an experimental research design, single-blind, and randomly assigned groups, one experimental group and one control group.Data were collected five times in total, before surgery, 24 hours after surgery, 48 hours after surgery, 72 hours after surgery and 3 months after surgery.All five data collections are required to fill in the Numerical Rating Scale (NRS) state-trait anxiety inventory (STAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- Conditions
- Arthroplasty, Knee Replacement
- Being tested
- combined care guidance, general care guidance
- Keywords
- Total knee replacement, pain scores, anxiety levels, joint mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined care guidanceBehavioural
Pain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker
general care guidanceBehavioural
general care guidance
| Study group | Role | What they receive |
|---|---|---|
| combined care guidance | Experimental | Pain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker Receives: Behavioral: combined care guidance |
| general care guidance | Active comparator | Verbal explanation of pain and rehabilitation exercise instructions after surgery Receives: Behavioral: general care guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
Using the Numerical Rating Scale to assess postoperative pain in patients undergoing knee replacement surgery.0 points are not painful, 10 points are the most painful.
Measured: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
anxiety levels
Assessing Anxiety Levels After Knee Replacement Using the State-Trait Anxiety Inventory.Scale scores range from 20 to 80, with lower scores indicating less severe anxiety, 20-39 indicating mild anxiety, 40-59 indicating moderate anxiety, and 60-80 indicating severe anxiety.
Measured: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
joint mobility
Assessment of range of motion after knee surgery using the Western Ontario and McMaster Universities Osteoarthritis Index.
Measured: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- LI YING-HUNG, 32, Principal investigator, Employment relationship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393075
- Sponsor's protocol ID
- 2023-08-016AC
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Combined Care Guidance on Pain, Anxiety and Joint Range of Motion in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06393075
- Acronym / sponsor ID
- 2023-08-016AC
- Conditions
- Arthroplasty, Knee Replacement
- Keywords
- Total knee replacement, pain scores, anxiety levels, joint mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 May 2024 (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.
The goal of this clinical trial is to compare the effectiveness of combined care guidance and general care guidance on pain scores, anxiety levels and joint mobility in patients undergoing total artificial knee replacement. The main questions it aims to answer are:
- Does combined care coaching reduce patient pain scores and anxiety levels after surgery?
- Does combined care guidance improve knee joint mobility after surgery? Researchers will compare combined care guidance and general care to see if combined care guidance reduces patients' pain scores and anxiety levels after surgery, and improves knee joint mobility after surgery.
Participants will:
- Watch pain and rehabilitation exercise guidance videos before surgery and learn how to use a walker.
- Complete questionnaires before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.
- Questionnaire records pain level, anxiety level and joint mobility.
Detailed description
Background:The population is aging rapidly, and an aging society is approaching. According to Taiwan government statistics, the population over 65 years old has reached 16.2%. The number of people suffering from knee osteoarthritis has reached 860,000, and the number of patients undergoing total artificial knee replacement has reached 29,000. people.Artificial knee replacement can effectively relieve joint pain, correct joint deformities, and improve joint function. However, patients who undergo total artificial knee replacement still experience moderate to severe pain after surgery. Effective pain control can promote early rehabilitation and early ambulation of patients. In clinical practice, it is more common to provide a single interventional measure to improve the pain level after surgery, but less to provide combined measures before surgery, which leads to the motivation for discussion.
Purpose:To compare the effectiveness of combined care guidance and general care Method:guidance on pain scores, anxiety levels and joint mobility of patients undergoing total artificial knee replacement before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.Experimental group: Researchers provided combined care, watched animated videos, demonstrated rehabilitation exercises and practiced walking using walkers.Control group: The researchers provided general preoperative care and demonstrated rehabilitation exercises and the use of walking aids after surgery.
:This study adopted an experimental research design, single-blind, and randomly assigned groups, one experimental group and one control group.Data were collected five times in total, before surgery, 24 hours after surgery, 48 hours after surgery, 72 hours after surgery and 3 months after surgery.All five data collections are required to fill in the Numerical Rating Scale (NRS) state-trait anxiety inventory (STAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined care guidance | Experimental | Behavioral: combined care guidancePain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker |
| general care guidance | Active comparator | Behavioral: general care guidanceVerbal explanation of pain and rehabilitation exercise instructions after surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who are 20 years old or above (inclusive), have undergone unilateral total knee replacement for the first time, have clear consciousness, can speak Mandarin and Taiwanese, have elementary school-level reading ability, and are willing to participate in the study
Key exclusion criteria (1 listed)
- Patients with bilateral total knee replacement, osteoarthritis tumors, rheumatoid arthritis, who are unable to cooperate with interventional measures, patients with dementia or cognitive dysfunction who are unable to cooperate; those who are participating in other pain control studies
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 |
|---|---|---|
| combined care guidancePain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker | Behavioural | combined care guidance |
| general care guidancegeneral care guidance | Behavioural | general care guidance |
Primary outcome
pain scores
Time frame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
Using the Numerical Rating Scale to assess postoperative pain in patients undergoing knee replacement surgery.0 points are not painful, 10 points are the most painful.
anxiety levels
Time frame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
Assessing Anxiety Levels After Knee Replacement Using the State-Trait Anxiety Inventory.Scale scores range from 20 to 80, with lower scores indicating less severe anxiety, 20-39 indicating mild anxiety, 40-59 indicating moderate anxiety, and 60-80 indicating severe anxiety.
joint mobility
Time frame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
Assessment of range of motion after knee surgery using the Western Ontario and McMaster Universities Osteoarthritis Index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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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.
LI YING-HUNG, 32 principal investigator
Employment relationship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined care guidance and general care guidance in people with Arthroplasty, Knee Replacement, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI YING-HUNG, 32 (0911887897, yhlee12@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores (time frame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery). The study lists 3 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 1 May 2024.