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

NCT ID: NCT07098390

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2026-03-25

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.

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.

Conditions

Arthoplasty, Pain, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Progressive Muscle Relaxation Exercise

Group Type: EXPERIMENTAL

Progressive Muscle Relaxation Exercise

Intervention Type: 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

Control

Participants in this group will receive routine perioperative care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Zühal Erdoğan

Gazi University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Zühal Erdoğan, RN, PhD, Assistant Professor

Role: primary

zuhalerdogan@gazi.edu.tr

+90 312 202 34 44

Other Identifiers

2025 - 1072

Identifier Type: -

Identifier Source: org_study_id