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Pain, PostoperativeNCT07109557

The Effect of Baduanjin on Patients Undergoing Knee Replacement Surgery

A study testing Baduanjin in people with Pain, Postoperative and Surgery, run by Niran Çoban at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative, Surgery, Knee Replacement
What is being tested?
Baduanjin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2025to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Having undergone Knee Replacement Surgery under general anesthesia
  • 18 years old and over,
  • Are in stable condition after surgery,
  • Are conscious, and
  • Volunteer to participate in the study.

Who cannot join

  • Patients with contraindications to Baduanjin exercises,
  • -• Over 70 years old,
  • Using anxiolytic and sedative drugs,
  • Patients with any mental illness and those who do not meet the inclusion criteria will not be included in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Niran Çoban

    Yalova, 77000

    Seçkin Özcan, 05418078632, seckin.ozcan@yalova.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Baduanjin on Pain, Comfort, and Quality of Recovery in Patients Undergoing Knee Replacement Surgery

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.

Read the 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

Being tested
Baduanjin
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaduanjinOther

    Baduanjin exercise

Study groups in NCT07109557
Study groupRoleWhat they receive
BaduanjinExperimentalParticipants in this arm will receive supervised Baduanjin exercises in addition to routine postoperative care. The Baduanjin protocol will begin on Postoperative Day 1 and continue for 3 weeks, with daily practice under guidance. Data collection will be performed at four time points using the Visual Analog Scale (VAS), the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40). Interview and Application Schedule: Interview I (Preoperative): Face-to-face interview one day before surgery; informed consent and sociodemographic data collection Interview II (Postoperative Day 1): Start of Baduanjin; baseline assessment with VAS, QoR-40, and Comfort Questionnaire Interview III (Postoperative Week 4): Follow-up assessment with VAS, QoR-40, and Comfort Questionnaire Interview IV (Postoperative Week 8): Final assessment with VAS, QoR-40, and Comfort Questionnaire
Receives: Other: Baduanjin
Standard careNo interventionDescription: Participants in this arm will receive standard postoperative nursing care and physical therapy, without any complementary intervention. Data will be collected at the same four time points as in the intervention group for comparison purposes. Interview and Application Schedule: Interview I (Preoperative): Face-to-face interview one day before surgery; informed consent and sociodemographic data collection Interview II (Postoperative Day 1): Baseline assessment with VAS, QoR-40, and Comfort Questionnaire Interview III (Postoperative Week 4): Follow-up assessment with VAS, QoR-40, and Comfort Questionnaire Interview IV (Postoperative Week 8): Final assessment with VAS, QoR-40, and Comfort Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Baduanjin on Pain

    Visual Analogue Scale:The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm).Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used in the pain assessment before and after the application.

    (Postoperative Day 1): Baseline assessment with VAS, (Postoperative Week 4): Follow-up assessment with VAS (Postoperative Week 8): Final assessment with VAS

    Measured: 12 month

  2. The Effect of Baduanjin on Quality of Recovery

    Quality of Recovery-40 (QoR-40): The QoR-40 scale evaluates post-surgical recovery and includes five sub-dimensions: emotional state, physical comfort, patient support, physical independence, and pain. It consists of 40 items, each rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing relevant items; total scores range from 40 to 200. Higher scores reflect better physical and emotional recovery, while lower scores indicate impaired well-being. The QoR-40 will be administered after transfer to the clinic, before the Su Jok therapy, to assess recovery quality in the first 24 hours post-surgery. Reassessments will be conducted at three time points: (1) Postoperative Day 1 (baseline), (2) Postoperative Week 4 (follow-up), and (3) Postoperative Week 8 (final). This structured approach will provide insight into the patient's recovery progress over time.

    Measured: 12 month

  3. The Effect of Baduanjin on Comfort

    General Comfort Scale: Developed by Kolcaba, the General Comfort Scale assesses individuals' comfort needs and the effectiveness of nursing interventions. It is structured on a taxonomy with three levels and four dimensions, reflecting the theoretical components of comfort. The scale includes 48 items rated on a four-point Likert scale. Items are a mix of positive and negative statements. In positive items, a score of 4 indicates high comfort, while 1 indicates low comfort. Negative items are reverse-scored before summing. The total score ranges from 48 to 192, with higher scores indicating greater overall comfort. In this study, the scale will be administered at three time points: (1) Postoperative Day 1 (baseline), (2) Postoperative Week 4 (follow-up), and (3) Postoperative Week 8 (final) to evaluate the progression of comfort throughout the recovery process.

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109557
Sponsor's protocol ID
NCBN
Status last verified
Aug 2025
First submitted
31 Jul 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ghandali E, Moghadam ST, Hadian MR, Olyaei G, Jalaie S, Sajjadi E. The effect of Tai Chi exercises on postural stability and control in older patients with knee osteoarthritis. J Bodyw Mov Ther. 2017 Jul;21(3):594-598. doi: 10.1016/j.jbmt.2016.09.001. Epub 2016 Sep 10.

    PubMed 28750970
  • Tao T, Shi MP, Tan BY, Zhang XS, Sun FL, Liu BR, Li SJ, Li ZH. Evaluation of traditional Chinese exercise for knee osteoarthritis (KOA): an overview of systematic reviews. Syst Rev. 2024 Jul 18;13(1):187. doi: 10.1186/s13643-024-02606-0.

    PubMed 39026375
  • Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

    PubMed 10740540
  • Karaman S, Arici S, Dogru S, Karaman T, Tapar H, Kaya Z, Suren M, Gurler Balta M. Validation of the Turkish version of the Quality of Recovery-40 questionnaire. Health Qual Life Outcomes. 2014 Jan 15;12:8. doi: 10.1186/1477-7525-12-8.

    PubMed 24428925
  • Wang, X., Pi, Y., Chen, B., et al. (2020). Effectiveness of Baduanjin exercise for limb function, activities of daily living, and quality of life in post-stroke patients: A systematic review and meta-analysis. Frontiers in Aging Neuroscience, 12, 123

  • Xiong X, Wang P, Li S, Zhang Y, Li X. Effect of Baduanjin exercise for hypertension: a systematic review and meta-analysis of randomized controlled trials. Maturitas. 2015 Apr;80(4):370-8. doi: 10.1016/j.maturitas.2015.01.002. Epub 2015 Jan 9.

    PubMed 25636242
  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PubMed 22588748

Questions about this trial

What is this clinical trial studying?

A study testing Baduanjin in people with Pain, Postoperative and Surgery, run by Niran Çoban 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NİRAN ÇOBAN (05301586912, nirancoban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effect of Baduanjin on Pain (time frame: 12 month). 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?

On the ClinicalTrials.gov record for NCT07109557, which also lists 7 linked publications.

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 12 Aug 2025.

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