Back to resultsThe Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery
Primary Purpose
Orthopedic Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive relaxation exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Orthopedic Surgery
Eligibility Criteria
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,
Sites / Locations
- Aksaray UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Routine maintenance and Progressive relaxation exercise
Routine maintenance
Outcomes
Primary Outcome Measures
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.
Postoperative Fatigue Scale
It is a scale created to evaluate the post-operative fatigue level of patients.
Secondary Outcome Measures
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.
Postoperative Fatigue Scale
It is a scale created to evaluate the post-operative fatigue level of patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05295199
Brief Title
The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery
Official Title
The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Routine maintenance and Progressive relaxation exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine maintenance
Intervention Type
Other
Intervention Name(s)
Progressive relaxation exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
General Comfort Scale
Description
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.
Time Frame
1st day after surgery
Title
Postoperative Fatigue Scale
Description
It is a scale created to evaluate the post-operative fatigue level of patients.
Time Frame
1st day after surgery
Secondary Outcome Measure Information:
Title
General Comfort Scale
Description
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.
Time Frame
4th day after surgery
Title
Postoperative Fatigue Scale
Description
It is a scale created to evaluate the post-operative fatigue level of patients.
Time Frame
4th day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Funda CETINKAYA
Organizational Affiliation
Aksaray University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aksaray University
City
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Funda ÇETİNKAYA
Phone
03822882769
Email
fundacetinkaya@aksaray.edu.tr
First Name & Middle Initial & Last Name & Degree
Kevser Sevgi Ünal Aslan, PhD
First Name & Middle Initial & Last Name & Degree
Elif Yencilek, Nurse
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery
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