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NCT Number: NCT06009341

Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

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.

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Key information

Conditions

Knee Arthroplasty

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muğla

Muğla, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

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.

Primary outcomes

  1. Knee Society Short Form (KSSF)

    Time frame: Change from Baseline KSSF at 12 weeks

    The 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.

  2. Visual Analog Scale (VAS)

    Time frame: Change from Baseline VAS at 12 weeks

    On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).

  3. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Change from Baseline TSK at 12 weeks

    The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

  4. EQ-5D-3L Quality of Life Scale

    Time frame: Change from Baseline EQ-5D-3L at 12 weeks

    The 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".

  5. Pain Catastrophising Scale (PCS)

    Time frame: Change from Baseline PCS at 12 weeks

    Scale 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.

  6. Activity Specific Balance Confidence Scale (ABC)

    Time frame: Change from Baseline ABC at 12 weeks

    This 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.

  7. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    Time frame: Change from Baseline FFABQ at 12 weeks

    The 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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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