Effect of Progressive Muscle Relaxation on Fear of Falling, Pain, and Anxiety in Arthroplasty Patients

Official title

The Effect of Progressive Muscle Relaxation Exercise Undergoing Total Hip and Knee Arthroplasty Patients on Fear of Falling, Pain and Anxiety Level

Overview

The study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of progressive muscle relaxation exercises on postoperative fear of falling, pain, and anxiety levels in patients undergoing total hip and knee arthroplasty. The study group will consist of patients who have undergone total hip or knee arthroplasty in the Orthopedics and Traumatology Clinic of a university hospital. Research data will be collected using the "Descriptive Information Form," the The Fear of Falling Scale, the Numeric Rating Scale (NRS), and the State-Trait Anxiety Inventory. Patients will be randomly assigned to intervention and control groups, and progressive muscle relaxation exercises will be applied to the patients in the intervention group.

Detailed description

When patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to the intervention and control groups.

In the preoperative period, upon admission to the clinic, patients in the intervention group will receive progressive muscle relaxation exercises (PMRE). To enhance concentration and minimize the impact of ambient noise, patients will listen to the exercises using headphones.

On the first postoperative day, the patient will be revisited by the researcher. After the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered, and the patient's pain and fear of falling will be evaluated. PMRE will then be performed, followed by the patient's first mobilization. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed. The PMRE sessions, lasting approximately 30 minutes, will be guided with slow and rhythmic instructions, delivered in a soft tone of voice and accompanied by music.

For patients in the control group, the administration of the questionnaires will be conducted in the same manner as in the intervention group. Upon admission to the clinic, the Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory will be completed through face-to-face interviews. On the first postoperative day, the patient will be revisited by the researcher, and after the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered again, and the patient's pain and fear of falling will be evaluated. The patient's first mobilization will then be carried out. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed.

Pain assessment will begin from the second postoperative hour. Pain intensity will be evaluated every 2 hours for the first 8 hours and then every 4 hours thereafter. After the final assessments of the control group are completed, PMRE will be administered by the researcher.

Interventions

• Behavioral Progressive Muscle Relaxation Exercise
  When patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to

Primary outcome measures

• The Fear of Falling Scale [Time frame: Baseline Twice a day on the first postoperative day]
• Numeric Rating Scale (NRS): [Time frame: Baseline Pain assessment will begin at the 2nd hour after surgery. During the first 8 hours, pain intensity will be evaluated every 2 hours, and then every 4 hours thereafter.]
• State-Trait Anxiety Inventory (STAI): [Time frame: Baseline Twice a day on the first postoperative day]

Eligibility criteria

Inclusion criteria

• • Patients aged 18 years or older,

• Undergoing primary and elective hip or knee arthroplasty,
• Admitted to the clinic one day before surgery,
• Having no other acute illness that could cause pain or anxiety,
• Voluntarily agreeing to participate in the study,
• Able to communicate

Exclusion criteria

• • Diagnosed with any neurological or psychiatric disorder affecting cognitive status,

• Diagnosed with an anxiety disorder,
• Developing complications during the perioperative period,
• Undergoing active cancer treatment,
• Receiving chronic pain treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Turkey (Türkiye) · 1 center

• Gazi University Hospital — Ankara

Identifiers

NCT: NCT07098390 · 2025 - 1072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗