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

Sponsor

Aksaray University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05295199

Collaborator

(none)

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery	Other: Progressive relaxation exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

General Comfort Scale [1st day after surgery]
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 [1st day after surgery]
It is a scale created to evaluate the post-operative fatigue level of patients.

Secondary Outcome Measures

General Comfort Scale [4th day after surgery]
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 [4th day after surgery]
It is a scale created to evaluate the post-operative fatigue level of patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aksaray University	Aksaray		Turkey	68100

Sponsors and Collaborators

Aksaray University

Investigators

Principal Investigator: Funda CETINKAYA, Aksaray University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Funda Cetinkaya, Principal Investigator, Aksaray University

ClinicalTrials.gov Identifier:

NCT05295199

Other Study ID Numbers:

2020/01-24

First Posted:

Mar 25, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Jul 22, 2022