Orthopedic DisorderNCT05248529
Effect of Preoperative Education Based on Roy Adaptation Model
A study testing Education booklet in people with Orthopedic Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Education booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Apr 2018
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- can read and write in Turkish A sufficient level of education to understand study procedures and training
Who cannot join
- hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Education Based on Roy Adaptation Model in Patients With Hip or Knee Arthroplasty on Physical Adaptation and Mobility
This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.
Read the detailed description
The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and Traumatology Surgery Service of a private University Hospital in Istanbul.
In the study, the number of samples to be taken; the training, the training group control group mobility scale scores between The Observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27.
The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assessment Form.
Randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. In the randomization table, those with the number 1 are assigned to the training group.
- Conditions
- Orthopedic Disorder
- Being tested
- Education booklet
- Keywords
- Roy Adaptation Model, hip arthroplasty, knee arthroplasty, physical adaptation, preoperative education
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education bookletOther
Hip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Within 12-24 hours before the surgery, the demonstrative education was given based on 'Hip Replacement Adaptation Booklet' and 'Knee Replacement Adaptation Booklet' to the patients in the intervention group. Receives: Other: Education booklet |
| Control gorup | No intervention | Routine preoperative preparation training was performed to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight in kilograms. It was used to determine the body mass index.
Measured: 5 days
height
height in meters. it was used to determine the body mass index.
Measured: 5 days
Body Mass Index
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: 5 days
Systolic and diastolic blood pressure
Both systolic and diastolic blood pressure is measured in units of millimeters of mercury (mmHg). It was used to determine the blood pressure of patients before mobilization.
Measured: 5 days
Secondary outcomes (2)
The Observer Mobility Scale
1 point indicates that the activity can be performed independently without verbal warning and physical assistance, 5 points indicate that the patient cannot perform the activity independently despite the verbal warning and physical assistance. The lowest score that can be obtained from the scale is 4 and the highest score is 20.
Measured: 5 days
The Patient Mobility Scale
As a scale score, 1 indicates that the patient has no pain during the activity and the level of difficulty when moving is minimal, while 5 indicates that the patient's pain during the activity is unbearable and the level of difficulty is greatest. The lowest score that can be obtained from the scale is 8 and the highest score is 40.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Nov 2017
- Primary completion1 Jan 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Model description
- The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Ozsoy Durmaz, MSc, Istanbul Medipol University Hospital
- Investigators
- Merve Ozsoy Durmaz, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248529
- Sponsor's protocol ID
- mozsoy
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An application for publication will be submitted in 2022.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Education Based on Roy Adaptation Model in Patients With Hip or Knee Arthroplasty on Physical Adaptation and Mobility
- ClinicalTrials.gov ID
- NCT05248529
- Acronym / sponsor ID
- mozsoy
- Conditions
- Orthopedic Disorder
- Keywords
- Roy Adaptation Model, hip arthroplasty, knee arthroplasty, physical adaptation, preoperative education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 21 Feb 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 research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.
Detailed description
The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and Traumatology Surgery Service of a private University Hospital in Istanbul.
In the study, the number of samples to be taken; the training, the training group control group mobility scale scores between The Observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27.
The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assessment Form.
Randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. In the randomization table, those with the number 1 are assigned to the training group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Education bookletWithin 12-24 hours before the surgery, the demonstrative education was given based on 'Hip Replacement Adaptation Booklet' and 'Knee Replacement Adaptation Booklet' to the patients in the intervention group. |
| Control gorup | No intervention | –Routine preoperative preparation training was performed to the patients in the control group. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- can read and write in Turkish A sufficient level of education to understand study procedures and training
Key exclusion criteria (1 listed)
- hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before
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 |
|---|---|---|
| Education bookletHip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge | Other | Intervention group |
Primary outcome
Weight
Time frame: 5 days
weight in kilograms. It was used to determine the body mass index.
height
Time frame: 5 days
height in meters. it was used to determine the body mass index.
Body Mass Index
Time frame: 5 days
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Systolic and diastolic blood pressure
Time frame: 5 days
Both systolic and diastolic blood pressure is measured in units of millimeters of mercury (mmHg). It was used to determine the blood pressure of patients before mobilization.
2 secondary outcomes
The Observer Mobility Scale
Time frame: 5 days
The Patient Mobility Scale
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Yes. An application for publication will be submitted in 2022.
Related trials for Orthopedic Disorder
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
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.
Merve Ozsoy Durmaz study director
Medipol 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 Education booklet in people with Orthopedic Disorder, run by Istanbul Medipol University Hospital 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: finished, as of the sponsor's last update on 8 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2022.