Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233773
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-01-11
Brief Title:
The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
The Effect of Kinesio Taping and Manual Lymph Drainage on Syndrome Severity Sleep Quality and Psychological Well-Being in Pregnant Women With Restless Leg Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Restless Leg Syndrome a progressive and recurrent chronic sensorimotor disorder that creates an irresistible urge to move the legs and a feeling of discomfort is seen in 154-260 of pregnant women in our country Restless Leg Syndrome has negative effects on sleep mood cognitive health daily activities and behavior in pregnant women It can also cause preeclampsia difficult labor and cesarean delivery Therefore it is important for pregnant women with Restless Leg Syndrome to be treated appropriately
It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain These methods are economical reliable and easy to apply However no study has been found in which Kinesio taping or manual lymphatic drainage was applied to a patient group with Restless Leg Syndrome during or outside pregnancy
The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Legs Syndrome severity sleep quality and psychological well-being in pregnant women with Restless Legs Syndrome
It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain These methods are economical reliable and easy to apply However no study has been found in which Kinesio taping or manual lymphatic drainage was applied to a patient group with Restless Leg Syndrome during or outside pregnancy
The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Legs Syndrome severity sleep quality and psychological well-being in pregnant women with Restless Legs Syndrome
Detailed Description:
Restless Leg Syndrome which creates an irresistible urge to move the legs is seen in 154-260 of pregnant women in our country Restless Leg Syndrome has negative effects on sleep mood cognitive health daily activities and behavior in pregnant women It can also cause preeclampsia difficult labor and cesarean delivery
It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health Studies have determined that progressive relaxation exercise and application of hot and cold water to the legs can reduce the severity of symptoms in pregnant women with Restless Leg Syndrome However the fact that progressive relaxation exercise covers a long period of time such as eight weeks may negatively affect the continuity of the practice in pregnant women Due to the enlargement of the abdomen in the following weeks of pregnancy pregnant women have difficulty in putting on and taking off compression stockings and sweat in the summer months some pregnant women may experience negative effects when applying hot and cold water such as heat sensitivity or the difficulty of repeating the application every evening For this reason it is necessary to increase the variety of non-pharmacological methods that can be recommended by healthcare personnel and by which pregnant women can choose the method most suitable for them in the symptom management of Restless Leg Syndrome that develops due to pregnancy Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain These methods are economical reliable and easy to apply However no study has been found in which Kinesio taping or manual lymphatic drainage was applied to the patient group with Restless Leg Syndrome during pregnancy or outside of pregnancy Therefore experimental studies evaluating the effectiveness of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome complaints are needed This study will determine the effectiveness of Kinesio taping and manual lymphatic drainage in Restless Leg Syndrome complaints and provide evidence for the hypothesis that Restless Leg Syndrome may be associated with venous insufficiency At the end of this project if it is proven that Kinesio taping has an effect on complaints a practical and ready-made Kinesio taping product development project that the pregnant woman can use on her own will be planned
The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome severity sleep quality and psychological well-being in pregnant women with Restless Leg Syndrome The study will be carried out at Erciyes University Hospital Pregnant women who meet the inclusion criteria will be randomized into groups Kinesio taping manual lymphatic drainage Kinesio taping manual lymphatic drainage Control with 20 people in each group
Data will be collected with Restless Leg Syndrome Diagnostic Criteria Survey Form Research Criteria Compliance Form Personal Information Form Restless Leg Syndrome Severity Rating Scale Richard-Campbell Sleep Scale Psychological Well-Being Scale and Application Satisfaction Form
After preliminary tests are performed kinesio tape will be applied to Kinesio taping groups legs Manual lymphatic drainage will be built for manual lymphatic drainage Group Tape will be attached to Kinesio tapingmanual lymphatic drainage group and manual lymphatic drainage will be made No treatment will be applied to the control group Tests will be repeated on the fourth and seventh days SPSS program will be used to analyze the data
Work packages of the study and by whom it will be carried out have been determined Precautions and plans have been made for the risks that may develop in the project
The experiences and knowledge gained at the end of the project will be shared by publishing articles or papers in international journals In addition it is expected that the scholars will increase their competencies in the field develop a commercial product after the study and create new studies or projects Most importantly a new method can be offered to pregnant women
It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health Studies have determined that progressive relaxation exercise and application of hot and cold water to the legs can reduce the severity of symptoms in pregnant women with Restless Leg Syndrome However the fact that progressive relaxation exercise covers a long period of time such as eight weeks may negatively affect the continuity of the practice in pregnant women Due to the enlargement of the abdomen in the following weeks of pregnancy pregnant women have difficulty in putting on and taking off compression stockings and sweat in the summer months some pregnant women may experience negative effects when applying hot and cold water such as heat sensitivity or the difficulty of repeating the application every evening For this reason it is necessary to increase the variety of non-pharmacological methods that can be recommended by healthcare personnel and by which pregnant women can choose the method most suitable for them in the symptom management of Restless Leg Syndrome that develops due to pregnancy Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain These methods are economical reliable and easy to apply However no study has been found in which Kinesio taping or manual lymphatic drainage was applied to the patient group with Restless Leg Syndrome during pregnancy or outside of pregnancy Therefore experimental studies evaluating the effectiveness of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome complaints are needed This study will determine the effectiveness of Kinesio taping and manual lymphatic drainage in Restless Leg Syndrome complaints and provide evidence for the hypothesis that Restless Leg Syndrome may be associated with venous insufficiency At the end of this project if it is proven that Kinesio taping has an effect on complaints a practical and ready-made Kinesio taping product development project that the pregnant woman can use on her own will be planned
The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome severity sleep quality and psychological well-being in pregnant women with Restless Leg Syndrome The study will be carried out at Erciyes University Hospital Pregnant women who meet the inclusion criteria will be randomized into groups Kinesio taping manual lymphatic drainage Kinesio taping manual lymphatic drainage Control with 20 people in each group
Data will be collected with Restless Leg Syndrome Diagnostic Criteria Survey Form Research Criteria Compliance Form Personal Information Form Restless Leg Syndrome Severity Rating Scale Richard-Campbell Sleep Scale Psychological Well-Being Scale and Application Satisfaction Form
After preliminary tests are performed kinesio tape will be applied to Kinesio taping groups legs Manual lymphatic drainage will be built for manual lymphatic drainage Group Tape will be attached to Kinesio tapingmanual lymphatic drainage group and manual lymphatic drainage will be made No treatment will be applied to the control group Tests will be repeated on the fourth and seventh days SPSS program will be used to analyze the data
Work packages of the study and by whom it will be carried out have been determined Precautions and plans have been made for the risks that may develop in the project
The experiences and knowledge gained at the end of the project will be shared by publishing articles or papers in international journals In addition it is expected that the scholars will increase their competencies in the field develop a commercial product after the study and create new studies or projects Most importantly a new method can be offered to pregnant women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None