Clinical trial NCT06393075: The Effectiveness of Combined Care for Knee Replacement Patients
Official title: Effect of Preoperative Combined Care Guidance on Pain, Anxiety and Joint Range of Motion in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthroplasty, Knee Replacement
Keywords: Total knee replacement
pain scores
anxiety levels
joint mobility
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: pain scores
timeFrame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
measure: anxiety levels
timeFrame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
measure: joint mobility
timeFrame: baseline, 24 hours, 48 hours, 72 hours and three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Employment relationship
name: LI YING-HUNG, 32
role: PRINCIPAL_INVESTIGATOR
References: