Orthopedic SurgeryNCT05295199

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

A study testing Progressive relaxation exercise in people with Orthopedic Surgery, run by Aksaray University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Orthopedic Surgery
What is being tested?: Progressive relaxation exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Mar 2022to 30 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

Aksaray University
Aksaray, 68100
Funda ÇETİNKAYA, 03822882769, fundacetinkaya@aksaray.edu.tr
Kevser Sevgi Ünal Aslan, PhD
Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Conditions: Orthopedic Surgery
Being tested: Progressive relaxation exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Progressive relaxation exerciseOther
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.

Study groups in NCT05295199
Study group	Role	What they receive
Experimental	Experimental	Routine maintenance and Progressive relaxation exercise Receives: Other: Progressive relaxation exercise
Control	No intervention	Routine maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1st day after surgery
Postoperative Fatigue Scale
It is a scale created to evaluate the post-operative fatigue level of patients.
Measured: 1st day after surgery

Secondary outcomes (2)

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.
Measured: 4th day after surgery
Postoperative Fatigue Scale
It is a scale created to evaluate the post-operative fatigue level of patients.
Measured: 4th day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202230 Aug 2022

First posted25 Mar 2022
Study start10 Mar 2022
Primary completion30 Aug 2022 (estimated)
Study completion30 Aug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05295199
Sponsor's protocol ID: 2020/01-24
Status last verified: Jul 2022
First submitted: 10 Mar 2022
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Orthopedic Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery
ClinicalTrials.gov ID: NCT05295199
Acronym / sponsor ID: 2020/01-24
Conditions: Orthopedic Surgery
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Aksaray UniversityUniversity, hospital or other
Study start: 10 Mar 2022 (actual)
Primary completion: 30 Aug 2022 (estimated)
Study completion: 30 Aug 2022 (estimated)
First posted: 25 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Other: Progressive relaxation exerciseRoutine maintenance and Progressive relaxation exercise
Control	No intervention	–Routine maintenance

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Progressive relaxation exerciseProgressive 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.	Other	Experimental

Primary outcome

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

2 secondary outcomes

General Comfort Scale
Time frame: 4th day after surgery
Postoperative Fatigue Scale
Time frame: 4th day after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Individual participant dataSharing planned: No

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aksaray University

Aksaray, Turkey (Türkiye)

03822882769

fundacetinkaya@aksaray.edu.tr

Funda CETINKAYA principal investigator

Aksaray University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Progressive relaxation exercise in people with Orthopedic Surgery, run by Aksaray University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Comfort Scale (time frame: 1st day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.