The Effectiveness of Combined Care for Knee Replacement Patients

NCT06393075 | Not Yet Recruiting

• 1 other identifier: 2023-08-016AC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroplasty, Knee Replacement

Keywords

Total knee replacement; pain scores; anxiety levels; joint mobility

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  baseline, 24 hours, 48 hours, 72 hours and three months after surgery

Study Arms (2)

combined care guidance

EXPERIMENTAL

Pain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker

Behavioral: combined care guidance

general care guidance

ACTIVE COMPARATOR

Verbal explanation of pain and rehabilitation exercise instructions after surgery

Behavioral: general care guidance

Interventions

combined care guidance BEHAVIORAL

Pain care guidance animation Rehabilitation exercise guidance animation Demonstrate how to perform rehabilitation exercises Demonstrate how to use a walker

combined care guidance

general care guidance BEHAVIORAL

general care guidance

general care guidance

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Study Officials

• LI YING-HUNG, 32

  Employment relationship

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LI YING-HUNG, 32

CONTACT

0911887897; yhlee12@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

TW (1)