PregnancyNCT06233773
The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome
A study testing Kinesio Taping and Manual Lymph Drainage in people with Pregnancy and Restless Leg Syndrome, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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 15.4-26.0% of pregnant women in our country. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Restless Leg Syndrome, Nursing
- What is being tested?
- Kinesio Taping and Manual Lymph Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to Apr 2025
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Literate,
- Gestational week 13 and above,
- She has a singleton pregnancy,
- Presence of RLS according to the RLS Diagnostic Criteria Questionnaire and physician examination,
- A score of 11 or above on the RLS Severity Rating Scale,
- Pregnant women taking iron, vitamin D, magnesium and calcium will be included in the study.
Who cannot join
- Pre-pregnancy RLS,
- Communication barriers,
- Absolute bed rest for reasons such as cervical insufficiency, premature rupture of membranes or risk of preterm labor,
- Have any psychiatric illness, use antipsychotic and/or antidepressant medication,
- Acute infection of bacterial or viral origin,
- Varicose veins in the feet and legs and severe lymphedema (circumference difference between both extremities over 5 cm),
- Have a dermatologic problem in their feet and legs,
- Pregnant women with rheumatic diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, systemic lupus erythematosus, fibromyalgia will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Medical faculty hospital
Kayseri, Talas, 38280
İptisam İpek Müderris, Prof. Dr.
About this study
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
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 15.4-26.0% 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.
Read the detailed description
Restless Leg Syndrome, which creates an irresistible urge to move the legs, is seen in 15.4-26.0% 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 group's legs. Manual lymphatic drainage will be built for manual lymphatic drainage Group. Tape will be attached to Kinesio taping+manual 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.
- Conditions
- Pregnancy, Restless Leg Syndrome, Nursing
- Being tested
- Kinesio Taping, Manual Lymph Drainage, Control Group
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingProcedure or surgery
Kinesio Taping
Manual Lymph DrainageProcedure or surgery
Manual Lymph Drainage Group
Control GroupOther
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping Group | Experimental | In this project, Kinesio Taping will be applied to the Kinesio Taping group to reduce pain and support circulation. In this study, space correction method to reduce pain and lymphatic correction technique to support circulation will be applied from Kinesio Taping methods. In the study, in order to determine the susceptibility to allergy to kinesio tape, a five cm application will be made on the outer lateral region of the arms of pregnant women and waited for 10 minutes. Before the application, the physiotherapist will clean the application area with volatile alcohol for correct and good adhesion of the tape. Four bands of 10 cm each will be cut for the application. In order to protect the tape during the movement of the person, all corners will be oval shaped and the kinesio tape will be adhered to the BL-40 and BL-57 points bilaterally using 25-50% tension with the space correction method. Receives: Procedure: Kinesio Taping |
| Manual Lymph Drainage Group | Experimental | Before the application, the pregnant woman will open both lower extremities, including the knee area, in a semi-sitting position. The other body parts will be covered with a sheet/sweater so that the leg area is open. Without applying anything (oil, vaseline, cream) to the leg, the physiotherapist will perform Manual Lymph Drainage using his/her hands. The pregnant woman will be asked to do 10 repetitions of diaphragmatic breathing exercise. Popliteal lymph nodes will be stimulated manually 7 times. The anterior and medial knee will be stimulated 7 times each with circular movements. Manual Lymph Drainage will be performed on the front of the leg with the pumping technique and on the back of the leg with the scooping movement. The procedure will be repeated 3 times to provide drainage in the same area. The ankle will be stimulated 7 times with circular movements. The inferior and posterior parts of both the medial malleolus and lateral malleolus will be stimulated. Receives: Procedure: Manual Lymph Drainage |
| Kinesio Taping and Manual Lymph Drainage Group | Experimental | In this group, Kinesio Taping and Manual Lymph Drainage will be performed together to support circulation and reduce pain. All of the procedures performed in the Kinesio Taping Group and the Manual Lymph Drainage Group will be performed in parallel. After Kinesio Taping, Manual Lymph Drainage will be performed for 6 days. The kinesio tape will be renewed on the fourth day and will remain for three more days. Receives: Procedure: Kinesio Taping; Procedure: Manual Lymph Drainage |
| Control Group | Active comparator | Pregnant women in the control group will not be subjected to any intervention other than routine follow-up and care at the hospital. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Leg Syndrome Diagnostic Criteria Survey Form
The diagnosis form was created by the International Restless Legs Syndrome Study Group in 1995, based on the patient's history. The form, with a Cronbach alpha coefficient of 0.81, consists of 5 questions. A diagnosis of Restless Leg Syndrome is made by answering "yes" to all questions on the form. The reliability and validity study of the form in Turkey was conducted.
Measured: 13 months
Research Criteria Eligibility Form
The form created by the researchers will be used to determine whether pregnant women meet the eligibility criteria for the study. The form consists of two parts: inclusion criteria and exclusion criteria. Criteria are answered yes or no. In order for pregnant women to be included in the study, they must answer yes to all inclusion criteria and no to all exclusion criteria.
Measured: 13 months
Personal Information Form
The form prepared by the researchers consists of questions containing socio-demographic and obstetric characteristics of women and a section containing lower extremity circumference measurement values of pregnant women.
Measured: 13 months
Restless Leg Syndrome Severity Rating Scale
Scale was developed by the International Restless Legs Syndrome Study Group. The Restless Leg Syndrome Rating Scale, with a Cronbach alpha coefficient of 0.82, consists of 10 questions. Restless Leg Syndrome severity values in each question are graded as having no effect of Restless Leg Syndrome (0 points) or having a very severe effect (4 points). Thus, a total score is obtained, with the entire score range ranging between 0 and 40. The score between 1-10 indicates the presence of mild, the score between 11-20 indicates the presence of moderate, the score between 21-30 indicates the presence of severe, and the score between 31-40 indicates the presence of very severe Restless Leg Syndrome. A validity and reliability study of the scale was conducted in our country.
Measured: 13 months
Richard-Campbell Sleep Scale
It was developed by Richards in 1987. The Richard-Campbell Sleep Scale consists of 6 items and this scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. Each item of the scale is evaluated using the visual analog scale technique ranging from 0 to 100. A score of "0-25" from the scale indicates "very poor sleep" and a score of "76-100" indicates "very good sleep". When calculating the total score of the scale, the scores from 5 items are added together, and the 6th item, which evaluates the noise level in the environment, is not included in the total score evaluation. It is thought that as the scale score increases, the patient's sleep quality also increases.
Measured: 13 months
Psychological Well-Being Scale
The scale was first named "Psychological Well-Being Scale", but its name was later revised to "Flourishing Scale", as it was thought that it would better express psychological well-being. The adaptation of the scale to Turkish was done, and the first name of the scale was used on the grounds that it was not the exact equivalent of the word flourishing. The scale, which consists of 8 items, is one-dimensional and contains positive expressions. The lowest score that can be obtained from the 7-point Likert type scale (between 1: Strongly disagree and 7: Strongly agree) is 8 and the highest score is 56. High scores on the unidimensional scale indicate a high level of psychological well-being. In the reliability study of the scale, the Cronbach's alpha internal consistency was calculated as 0.80 and the test-retest coefficient was calculated as 0.86, and it was stated that the scale is valid and reliable for use.
Measured: 13 months
Application Satisfaction Form
The form was created by the researchers to determine the participants' satisfaction levels with the application. Satisfaction levels consist of two parts, where positive and negative feedback about the application is expressed numerically on a 10-point scale and open-ended. The form will be filled out by pregnant women at the end of the application along with the final test.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- This research is a randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaplan, TC Erciyes University
- Investigators
- MÜRÜVVET BAŞER, Prof. Dr., Principal investigator, Erciyes U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233773
- Sponsor's protocol ID
- Erciyes U - Ali KAPLAN
- Status last verified
- May 2024
- First submitted
- 11 Jan 2024
- Last updated
- 13 May 2024
- 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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06233773
- Acronym / sponsor ID
- Erciyes U - Ali KAPLAN
- Conditions
- Pregnancy, Restless Leg Syndrome, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 31 Jan 2024 (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.
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 15.4-26.0% 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.
Detailed description
Restless Leg Syndrome, which creates an irresistible urge to move the legs, is seen in 15.4-26.0% 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 group's legs. Manual lymphatic drainage will be built for manual lymphatic drainage Group. Tape will be attached to Kinesio taping+manual 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This research is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping Group | Experimental | Procedure: Kinesio TapingIn this project, Kinesio Taping will be applied to the Kinesio Taping group to reduce pain and support circulation. In this study, space correction method to reduce pain and lymphatic correction technique to support circulation will be applied from Kinesio Taping methods. In the study, in order to determine the susceptibility to allergy to kinesio tape, a five cm application will be made on the outer lateral region of the arms of pregnant women and waited for 10 minutes. Before the application, the physiotherapist will clean the application area with volatile alcohol for correct and good adhesion of the tape. Four bands of 10 cm each will be cut for the application. In order to protect the tape during the movement of the person, all corners will be oval shaped and the kinesio tape will be adhered to the BL-40 and BL-57 points bilaterally using 25-50% tension with the space correction method. |
| Manual Lymph Drainage Group | Experimental | Procedure: Manual Lymph DrainageBefore the application, the pregnant woman will open both lower extremities, including the knee area, in a semi-sitting position. The other body parts will be covered with a sheet/sweater so that the leg area is open. Without applying anything (oil, vaseline, cream) to the leg, the physiotherapist will perform Manual Lymph Drainage using his/her hands. The pregnant woman will be asked to do 10 repetitions of diaphragmatic breathing exercise. Popliteal lymph nodes will be stimulated manually 7 times. The anterior and medial knee will be stimulated 7 times each with circular movements. Manual Lymph Drainage will be performed on the front of the leg with the pumping technique and on the back of the leg with the scooping movement. The procedure will be repeated 3 times to provide drainage in the same area. The ankle will be stimulated 7 times with circular movements. The inferior and posterior parts of both the medial malleolus and lateral malleolus will be stimulated. |
| Kinesio Taping and Manual Lymph Drainage Group | Experimental | Procedure: Kinesio Taping, Procedure: Manual Lymph DrainageIn this group, Kinesio Taping and Manual Lymph Drainage will be performed together to support circulation and reduce pain. All of the procedures performed in the Kinesio Taping Group and the Manual Lymph Drainage Group will be performed in parallel. After Kinesio Taping, Manual Lymph Drainage will be performed for 6 days. The kinesio tape will be renewed on the fourth day and will remain for three more days. |
| Control Group | Active comparator | Other: Control GroupPregnant women in the control group will not be subjected to any intervention other than routine follow-up and care at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years of age,
- Literate,
- Gestational week 13 and above,
- She has a singleton pregnancy,
- Presence of RLS according to the RLS Diagnostic Criteria Questionnaire and physician examination,
Key exclusion criteria (8 listed)
- Pre-pregnancy RLS,
- Communication barriers,
- Absolute bed rest for reasons such as cervical insufficiency, premature rupture of membranes or risk of preterm labor,
- Have any psychiatric illness, use antipsychotic and/or antidepressant medication,
- Acute infection of bacterial or viral origin,
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 |
|---|---|---|
| Kinesio TapingKinesio Taping | Procedure or surgery | Kinesio Taping Group, Kinesio Taping and Manual Lymph Drainage Group |
| Manual Lymph DrainageManual Lymph Drainage Group | Procedure or surgery | Kinesio Taping and Manual Lymph Drainage Group, Manual Lymph Drainage Group |
| Control GroupControl Group | Other | Control Group |
Primary outcome
Restless Leg Syndrome Diagnostic Criteria Survey Form
Time frame: 13 months
The diagnosis form was created by the International Restless Legs Syndrome Study Group in 1995, based on the patient's history. The form, with a Cronbach alpha coefficient of 0.81, consists of 5 questions. A diagnosis of Restless Leg Syndrome is made by answering "yes" to all questions on the form. The reliability and validity study of the form in Turkey was conducted.
Research Criteria Eligibility Form
Time frame: 13 months
The form created by the researchers will be used to determine whether pregnant women meet the eligibility criteria for the study. The form consists of two parts: inclusion criteria and exclusion criteria. Criteria are answered yes or no. In order for pregnant women to be included in the study, they must answer yes to all inclusion criteria and no to all exclusion criteria.
Personal Information Form
Time frame: 13 months
The form prepared by the researchers consists of questions containing socio-demographic and obstetric characteristics of women and a section containing lower extremity circumference measurement values of pregnant women.
Restless Leg Syndrome Severity Rating Scale
Time frame: 13 months
Scale was developed by the International Restless Legs Syndrome Study Group. The Restless Leg Syndrome Rating Scale, with a Cronbach alpha coefficient of 0.82, consists of 10 questions. Restless Leg Syndrome severity values in each question are graded as having no effect of Restless Leg Syndrome (0 points) or having a very severe effect (4 points). Thus, a total score is obtained, with the entire score range ranging between 0 and 40. The score between 1-10 indicates the presence of mild, the score between 11-20 indicates the presence of moderate, the score between 21-30 indicates the presence of severe, and the score between 31-40 indicates the presence of very severe Restless Leg Syndrome. A validity and reliability study of the scale was conducted in our country.
Richard-Campbell Sleep Scale
Time frame: 13 months
It was developed by Richards in 1987. The Richard-Campbell Sleep Scale consists of 6 items and this scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. Each item of the scale is evaluated using the visual analog scale technique ranging from 0 to 100. A score of "0-25" from the scale indicates "very poor sleep" and a score of "76-100" indicates "very good sleep". When calculating the total score of the scale, the scores from 5 items are added together, and the 6th item, which evaluates the noise level in the environment, is not included in the total score evaluation. It is thought that as the scale score increases, the patient's sleep quality also increases.
Psychological Well-Being Scale
Time frame: 13 months
The scale was first named "Psychological Well-Being Scale", but its name was later revised to "Flourishing Scale", as it was thought that it would better express psychological well-being. The adaptation of the scale to Turkish was done, and the first name of the scale was used on the grounds that it was not the exact equivalent of the word flourishing. The scale, which consists of 8 items, is one-dimensional and contains positive expressions. The lowest score that can be obtained from the 7-point Likert type scale (between 1: Strongly disagree and 7: Strongly agree) is 8 and the highest score is 56. High scores on the unidimensional scale indicate a high level of psychological well-being. In the reliability study of the scale, the Cronbach's alpha internal consistency was calculated as 0.80 and the test-retest coefficient was calculated as 0.86, and it was stated that the scale is valid and reliable for use.
Application Satisfaction Form
Time frame: 13 months
The form was created by the researchers to determine the participants' satisfaction levels with the application. Satisfaction levels consist of two parts, where positive and negative feedback about the application is expressed numerically on a 10-point scale and open-ended. The form will be filled out by pregnant women at the end of the application along with the final test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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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.
MÜRÜVVET BAŞER, Prof. Dr. principal investigator
Erciyes U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping and Manual Lymph Drainage in people with Pregnancy and Restless Leg Syndrome, run by TC Erciyes 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 7 inclusion and 8 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 13 May 2024. 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?
Contact Ali KAPLAN, Dr (05449069417, alikaplan@kayseri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restless Leg Syndrome Diagnostic Criteria Survey Form (time frame: 13 months). The study lists 7 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 13 May 2024.