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

NCT07098390 | Recruiting

• 1 other identifier: 2025 - 1072
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthoplasty, Pain, Anxiety

Outcome Measures

Primary Outcomes (3)

• The Fear of Falling Scale

  The Fear of Falling Scale consists of a single-item question asking participants to indicate their fear of falling on a four-point Likert scale: 1 = not afraid, 2 = slightly afraid, 3 = moderately afraid, and 4 = very afraid. This scale has been widely used in various studies, particularly among patients with hip fractures (Damar et al., 2018).

  Baseline Twice a day on the first postoperative day

• Numeric Rating Scale (NRS):

  The Numeric Rating Scale is a unidimensional tool designed to assess the intensity of pain, allowing patients to express their pain using numbers. It is an 11-point scale ranging from 0 (no pain) to 10 (unbearable pain). Scores of 1-3 indicate mild pain, 4-6 indicate moderate pain, and 7-10 indicate severe pain. It is a valid and reliable tool for assessing postoperative pain in conscious patients

  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):

  The State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. to measure individuals' levels of state and trait anxiety, was adapted into Turkish and validated by Öner and Le Compte (1977). The scale evaluates how individuals feel about themselves and consists of two subscales, both using a four-point Likert format. The first part, the State Anxiety Scale, includes 20 items and assesses how the individual feels at a specific moment and under specific conditions (Öner, 1985). The second part, the Trait Anxiety Scale, also includes 20 items and measures the individual's general tendency to experience anxiety. It was developed to reflect the anxiety experienced over the past seven days. Some items are reverse-scored when calculating the total score. In the State Anxiety Scale, 10 items (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) are reversed; in the Trait Anxiety Scale, 7 items (21, 26, 27, 30, 33, 36, 39) are reversed. After reversing the scores of negatively worded items, the tota

  Baseline Twice a day on the first postoperative day

Study Arms (2)

Progressive Muscle Relaxation Exercise

EXPERIMENTAL

Behavioral: Progressive Muscle Relaxation Exercise

Control

NO INTERVENTION

Participants in this group will receive routine perioperative care

Interventions

Progressive Muscle Relaxation Exercise BEHAVIORAL

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

Progressive Muscle Relaxation Exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Since the progressive muscle relaxation exercise (PMRE) is administered by the researcher in this study, blinding of the researcher will not be possible. However, to ensure participant blinding, PMRE will be provided to the control group after the final assessments are completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gazi University

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: July 28, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 25, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

TU (1)