The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery

This study was planned to determine the effect of progressive relaxation exercise to be applied after major orthopedic surgery on post-operative fatigue and comfort level.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Other: Progressive relaxation exercise

Detailed Description

The symptom of fatigue causes tension, anxiety, fear, and insomnia in the person. Fatigue also negatively affects the comfort level of the patient along with the symptoms experienced in individuals.Suggestions and evaluations of the professional healthcare team, especially nurses, are of great importance in the effective fight against fatigue of patients.In this study, it is carried out to determine the effect of progressive relaxation exercise applied after major orthopedic surgery on fatigue and comfort level.

Hypothesis

H1: Progressive relaxation exercise to be applied after major orthopedic surgery reduces the post-operative fatigue level of patients.

H2: Progressive relaxation exercise to be applied after major orthopedic surgery positively affects the comfort level of the patients.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aksaray, Turkey, 68100
    • Recruiting
    • Aksaray University
    • Sub-Investigator: Elif Yencilek, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients included in the study have undergone major orthopedic surgery (total knee or hip replacement, atroscopic surgery, vertebral surgery, shoulder surgery, amputation, etc.), Patients aged 18 and over Absence of speech and hearing problems Speak and understand Turkish

Exclusion Criteria:

• Being diagnosed with a psychiatric disorder, A complication developed in the patients before, during and three days after the operation,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Routine maintenance and Progressive relaxation exercise	Other: Progressive relaxation exercise; Progressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet.
NO_INTERVENTION: Control; Routine maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Comfort Scale	It is a scale developed to determine the comfort levels of patients.The lowest possible score is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases.	1st day after surgery
Postoperative Fatigue Scale	It is a scale created to evaluate the post-operative fatigue level of patients.	1st day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Comfort Scale	It is a scale developed to determine the comfort levels of patients.The lowest possible score is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases.	4th day after surgery
Postoperative Fatigue Scale	It is a scale created to evaluate the post-operative fatigue level of patients.	4th day after surgery

Collaborators and Investigators

• Sponsor: Aksaray University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2022
• Primary Completion (ANTICIPATED): August 30, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2020/01-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No