Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 10:56 PM
Study NCT ID:
NCT07109557
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Baduanjin on Patients Undergoing Knee Replacement Surgery
Sponsor:
Niran Çoban
Organization:
Study Overview
Official Title:
The Effect of Baduanjin on Pain, Comfort, and Quality of Recovery in Patients Undergoing Knee Replacement Surgery
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial aims to evaluate the effects of Baduanjin, a traditional Chinese mind-body exercise, on pain, comfort, and quality of recovery in patients undergoing total knee arthroplasty (TKA). The study will be conducted between July 2025 and July 2026 at Yalova Training and Research Hospital's Orthopedics Clinic. Sixty patients will be randomly assigned into two groups: an intervention group practicing Baduanjin and a control group receiving standard postoperative care. The intervention will begin on the first postoperative day and continue for three weeks. Outcome measures include the Visual Analog Scale (VAS) for pain, the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40) questionnaire. These assessments will be conducted weekly for three weeks. The control group will follow routine postoperative care without Baduanjin. The primary objective is to determine whether Baduanjin can improve postoperative outcomes in terms of pain reduction, increased comfort, and better recovery quality.
Detailed Description:
Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgeries, especially among elderly individuals, to relieve pain, improve joint function, and enhance quality of life in patients with advanced knee osteoarthritis. However, the postoperative period can be challenging due to significant pain, reduced comfort, limited mobility, and psychological distress, all of which may negatively affect the recovery process. Effective postoperative management is essential to reduce pain, improve comfort, and enhance the quality of recovery.
Pharmacological treatments are commonly used for postoperative pain management; however, their side effects and limitations have increased interest in complementary and integrative practices. One such practice is Baduanjin, a traditional Chinese mind-body exercise that consists of eight gentle, coordinated movements. These movements integrate physical posture, breathing control, and mental focus to promote physical and emotional well-being. Baduanjin can be practiced while standing or sitting, making it suitable for patients in the postoperative period. Studies suggest that Baduanjin may reduce pain, improve psychological states such as anxiety and depression, and promote faster physical recovery through improved circulation, joint flexibility, and relaxation.
This randomized controlled trial aims to evaluate the effects of Baduanjin exercises on pain intensity, comfort level, and quality of recovery in patients who have undergone total knee arthroplasty. The study will be conducted between July 2025 and July 2026 at Yalova Training and Research Hospital, Orthopedics Clinic. A total of 60 participants will be randomly assigned into two groups using a random number table: a Baduanjin group (intervention) and a control group. The intervention group will perform supervised Baduanjin exercises starting from the first postoperative day for a duration of three weeks. Exercises will be practiced under nurse supervision and consist of the eight classical Baduanjin movements.
Pain, comfort, and quality of recovery will be evaluated at the end of each week using the Visual Analog Scale (VAS), the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40) instrument. The control group will receive only routine postoperative care, including standard physical therapy and pain management, and will complete the same assessments at the same time intervals.
The primary hypothesis is that Baduanjin practice will significantly reduce pain, increase comfort levels, and improve the quality of recovery in patients undergoing TKA compared to standard care. The secondary objective is to contribute to the growing body of evidence supporting non-pharmacological, mind-body interventions in postoperative nursing care. Given its accessibility, safety, and ease of learning, Baduanjin may serve as a valuable complementary method to enhance surgical recovery and patient well-being
Pharmacological treatments are commonly used for postoperative pain management; however, their side effects and limitations have increased interest in complementary and integrative practices. One such practice is Baduanjin, a traditional Chinese mind-body exercise that consists of eight gentle, coordinated movements. These movements integrate physical posture, breathing control, and mental focus to promote physical and emotional well-being. Baduanjin can be practiced while standing or sitting, making it suitable for patients in the postoperative period. Studies suggest that Baduanjin may reduce pain, improve psychological states such as anxiety and depression, and promote faster physical recovery through improved circulation, joint flexibility, and relaxation.
This randomized controlled trial aims to evaluate the effects of Baduanjin exercises on pain intensity, comfort level, and quality of recovery in patients who have undergone total knee arthroplasty. The study will be conducted between July 2025 and July 2026 at Yalova Training and Research Hospital, Orthopedics Clinic. A total of 60 participants will be randomly assigned into two groups using a random number table: a Baduanjin group (intervention) and a control group. The intervention group will perform supervised Baduanjin exercises starting from the first postoperative day for a duration of three weeks. Exercises will be practiced under nurse supervision and consist of the eight classical Baduanjin movements.
Pain, comfort, and quality of recovery will be evaluated at the end of each week using the Visual Analog Scale (VAS), the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40) instrument. The control group will receive only routine postoperative care, including standard physical therapy and pain management, and will complete the same assessments at the same time intervals.
The primary hypothesis is that Baduanjin practice will significantly reduce pain, increase comfort levels, and improve the quality of recovery in patients undergoing TKA compared to standard care. The secondary objective is to contribute to the growing body of evidence supporting non-pharmacological, mind-body interventions in postoperative nursing care. Given its accessibility, safety, and ease of learning, Baduanjin may serve as a valuable complementary method to enhance surgical recovery and patient well-being
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: