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Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06009341
Enrollment
50
Registered
2023-08-24
Start date
2023-05-19
Completion date
2025-12-01
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Brief summary

In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.

Interventions

OTHERRehabilitation

The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants aged 50 and over * Participants indicated for unilateral or bilateral total knee arthoplasty * Individuals to be followed after surgery

Exclusion criteria

* Other surgeries * Individuals with neurological and orthopedic diagnoses * Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating * Illiterate individuals * Presence of malignancy * Not signing the consent form

Design outcomes

Primary

MeasureTime frameDescription
Knee Society Short Form (KSSF)Change from Baseline KSSF at 12 weeksThe scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.
Visual Analog Scale (VAS)Change from Baseline VAS at 12 weeksOn a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
Tampa Scale for Kinesiophobia (TSK)Change from Baseline TSK at 12 weeksThe questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
EQ-5D-3L Quality of Life ScaleChange from Baseline EQ-5D-3L at 12 weeksThe EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning worst imaginable health and 100 meaning best imaginable health.
Pain Catastrophising Scale (PCS)Change from Baseline PCS at 12 weeksScale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Activity Specific Balance Confidence Scale (ABC)Change from Baseline ABC at 12 weeksThis scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)Change from Baseline FFABQ at 12 weeksThe Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026