Back to resultsCauses of Kinesiophobia in Lymphedema
Primary Purpose
Lymphedema
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
survey application
Sponsored by
About this trial
This is an interventional health services research trial for Lymphedema focused on measuring lymphedema, Kinesiophobia
Eligibility Criteria
Inclusion Criteria:
- Those between the ages of 18-65
- To be diagnosed with lymphedema in the unilateral lower extremity
- Volunteering to work
- Not having orthopedic disorders in the lower extremities
Exclusion Criteria:
- Not volunteering to participate in the research
- Having bilateral lower extremity lymphedema
- Having an active infection
- Having a mental cognitive disorder
- Being unable to communicate and cooperate
Sites / Locations
- Ankara City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Study Group
control group
Arm Description
People who have lymphedema
healty people
Outcomes
Primary Outcome Measures
Kinesiophopia Causes Scale
It is a 20 question survey. A higher score on the questionnaire indicates that they have more fear of movement.
functional assessment of chronic illness therapy
It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days.
Lymphedema Quality of Life Questionnaire
It is a survey consisting of 21 questions. High scores indicate lower quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT05105594
First Posted
October 26, 2021
Last Updated
November 8, 2021
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05105594
Brief Title
Causes of Kinesiophobia in Lymphedema
Official Title
Investigation of Causes of Kinesiophobia, Fatigue and Quality of Life in Patients With Lower Extremity Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent
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
In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
lymphedema, Kinesiophobia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
People who have lymphedema
Arm Title
control group
Arm Type
Active Comparator
Arm Description
healty people
Intervention Type
Other
Intervention Name(s)
survey application
Other Intervention Name(s)
Lymphedema Group
Intervention Description
Fear of movement will be evaluated with the Kinesiophopia Causes Scale. It is a 20-question survey in which the causes of fear of movement are investigated. Functional Evaluation of Treatment of Fatigue Chronic Disease will be assessed by the Fatigue Questionnaire. It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days. Quality of Life will be assessed by the Lymphedema Quality of Life Questionnaire.
Primary Outcome Measure Information:
Title
Kinesiophopia Causes Scale
Description
It is a 20 question survey. A higher score on the questionnaire indicates that they have more fear of movement.
Time Frame
10 minutes
Title
functional assessment of chronic illness therapy
Description
It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days.
Time Frame
10 minutes
Title
Lymphedema Quality of Life Questionnaire
Description
It is a survey consisting of 21 questions. High scores indicate lower quality of life.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Those between the ages of 18-65
To be diagnosed with lymphedema in the unilateral lower extremity
Volunteering to work
Not having orthopedic disorders in the lower extremities
Exclusion Criteria:
Not volunteering to participate in the research
Having bilateral lower extremity lymphedema
Having an active infection
Having a mental cognitive disorder
Being unable to communicate and cooperate
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06800
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Causes of Kinesiophobia in Lymphedema
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