Fear of Other Medical CareNCT06133608
Kinesiophobia and Fear of Falling After Femur Fracture
A study testing MOBILIZATION TRAINING in people with Fear of Other Medical Care, run by Kastamonu University.
Trial summary
This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fear of Other Medical Care
- What is being tested?
- MOBILIZATION TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 20 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who will undergo hip prosthesis due to femur fracture after a fall,
- Patients who were mobilized before falling,
- Being over 65 years of age
- Volunteering to participate in the research
- No previous hip arthroplasty
- Ability to read and write
- There is no perception disorder or psychiatric disorder that would hinder communication.
Who cannot join
- Having difficulty in communicating
- Severe sensory loss related to vision and hearing
About this study
Official title: The Effect of Mobilization Training on Kinesiophobia and Fear of Falling in Patients Undergoing Hip Arthroplasty After Femur Fracture
This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.
Read the detailed description
As a result of the changes that occur in old age, individuals face different problems and risks more frequently than the younger age group. One of the most important among these is falls, which cause high mortality and morbidity in this age group. Hip fractures that occur after a fall are the most distressing injuries that elderly individuals experience. Hip arthroplasty is one of the treatment methods preferred by patients who have hip fractures after a fall. After hip arthroplasty, elderly patients may avoid mobilization due to the fear of falling and damaging the prosthesis. This can lead to restriction of activities and a decrease in functional independence. This avoidance behavior increases with the fear of falling. Avoidance of movement due to fear of falling is defined as "kinesiophobia". Studies have stated that mobilization training before or after hip arthroplasty surgery is effective in postoperative mobilization. For this reason, it is thought that providing mobilization training to patients undergoing hip arthroplasty surgery will lead to more success in mobilization.
This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.
- Conditions
- Fear of Other Medical Care
- Being tested
- MOBILIZATION TRAINING
- Keywords
- Fear of moving, Fear of falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBILIZATION TRAININGOther
Things to consider in the hospital in the early period after surgery: The first day in the hospital after surgery, the importance of the abduction pillow and early mobilization,
- Exercises performed in bed in the early period after surgery: Exercises such as ankle pump, ankle rotation, bed-supported knee bending, hip contraction, opening exercise, thigh exercise, straight leg raise,
- Early standing up: Activities such as sitting in bed or on a chair, standing up with the help of a walker, walking,
- Exercises performed while standing: Exercises such as lifting the knee, opening the leg to the side,
- Daily living activities: It will provide information on regulating ADLs such as bathing, dressing, using the toilet, getting into and driving the car, going up and down stairs, eating, sleeping, doing housework, sexual life, and information about the safety precautions that should be taken at home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients in the intervention group will be educated by watching videos on the first day after surgery, in addition to routine clinical education. On the 10th post-operative day, the patients will be called by the researcher and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered. Receives: Other: MOBILIZATION TRAINING |
| Control | No intervention | The control group will receive routine clinical training. On the 10th post-operative day, the patients will be called by the researcher, and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia
Tampa Scale for Kinesiophobia is a 17-question checklist and is used for acute and chronic low back pain, fibromyalgia, and diseases associated with musculoskeletal injuries and whiplash. A 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale. A total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. Permission was obtained from the researchers for the use of the scale.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start2 Jan 2024 (estimated)
- Primary completion5 Jun 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Other Medical CareStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHİNUR DURMUŞ İSKENDER, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133608
- Sponsor's protocol ID
- KastamonuU2
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization Training on Kinesiophobia and Fear of Falling in Patients Undergoing Hip Arthroplasty After Femur Fracture
- ClinicalTrials.gov ID
- NCT06133608
- Acronym / sponsor ID
- KastamonuU2
- Conditions
- Fear of Other Medical Care
- Keywords
- Fear of moving, Fear of falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 5 Jun 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 15 Nov 2023 (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 will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.
Detailed description
As a result of the changes that occur in old age, individuals face different problems and risks more frequently than the younger age group. One of the most important among these is falls, which cause high mortality and morbidity in this age group. Hip fractures that occur after a fall are the most distressing injuries that elderly individuals experience. Hip arthroplasty is one of the treatment methods preferred by patients who have hip fractures after a fall. After hip arthroplasty, elderly patients may avoid mobilization due to the fear of falling and damaging the prosthesis. This can lead to restriction of activities and a decrease in functional independence. This avoidance behavior increases with the fear of falling. Avoidance of movement due to fear of falling is defined as "kinesiophobia". Studies have stated that mobilization training before or after hip arthroplasty surgery is effective in postoperative mobilization. For this reason, it is thought that providing mobilization training to patients undergoing hip arthroplasty surgery will lead to more success in mobilization.
This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: MOBILIZATION TRAININGPatients in the intervention group will be educated by watching videos on the first day after surgery, in addition to routine clinical education. On the 10th post-operative day, the patients will be called by the researcher and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered. |
| Control | No intervention | –The control group will receive routine clinical training. On the 10th post-operative day, the patients will be called by the researcher, and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients who will undergo hip prosthesis due to femur fracture after a fall,
- Patients who were mobilized before falling,
- Being over 65 years of age
- Volunteering to participate in the research
- No previous hip arthroplasty
Key exclusion criteria (2 listed)
- Having difficulty in communicating
- Severe sensory loss related to vision and hearing
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 |
|---|---|---|
| MOBILIZATION TRAININGThings to consider in the hospital in the early period after surgery: The first day in the hospital after surgery, the importance of the abduction pillow and early mobilization, * Exercises performed in bed in the early period after surgery: Exercises such as ankle pump, ankle rotation, bed-supported knee bending, hip contraction, opening exercise, thigh exercise, straight leg raise, * Early standing up: Activities such as sitting in bed or on a chair, standing up with the help of a walker, walking, * Exercises performed while standing: Exercises such as lifting the knee, opening the leg to the side, * Daily living activities: It will provide information on regulating ADLs such as bathing, dressing, using the toilet, getting into and driving the car, going up and down stairs, eating, sleeping, doing housework, sexual life, and information about the safety precautions that should be taken at home. | Other | Experimental |
Primary outcome
Tampa Scale for Kinesiophobia
Time frame: 10 days
Tampa Scale for Kinesiophobia is a 17-question checklist and is used for acute and chronic low back pain, fibromyalgia, and diseases associated with musculoskeletal injuries and whiplash. A 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale. A total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. Permission was obtained from the researchers for the use of the scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MOBILIZATION TRAINING in people with Fear of Other Medical Care, run by Kastamonu University.
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 7 inclusion and 2 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Tampa Scale for Kinesiophobia (time frame: 10 days). 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 15 Nov 2023.