Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

NCT06009341 | Completed

• 1 other identifier: Artroplasti gevşeme
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (7)

• Knee Society Short Form (KSSF)

  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.

  Change from Baseline KSSF at 12 weeks

• Visual Analog Scale (VAS)

  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).

  Change from Baseline VAS at 12 weeks

• Tampa Scale for Kinesiophobia (TSK)

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

  Change from Baseline TSK at 12 weeks

• EQ-5D-3L Quality of Life Scale

  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".

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

• Pain Catastrophising Scale (PCS)

  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.

  Change from Baseline PCS at 12 weeks

• Activity Specific Balance Confidence Scale (ABC)

  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.

  Change from Baseline ABC at 12 weeks

• Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

  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.

  Change from Baseline FFABQ at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day.

Other: Rehabilitation

Control Group

ACTIVE COMPARATOR

The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given.

Other: Rehabilitation

Interventions

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla

Muğla, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatih Özden, PhD

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: May 19, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)