Pregnancy Complications Clinical Trial
Official title:
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema, and Quality of Life in Pregnant Women: Randomized Controlled Trial
Verified date | March 2024 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 10, 2023 |
Est. primary completion date | June 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - being pregnant between the ages of 18-40, - being in the 24-36 weeks of pregnancy, - not being at risk of pregnancy, - being pregnant with a single baby, - having complaints of pain or edema in the lower extremities, - volunteering to participate in the study 3 days a week Exclusion Criteria: - multiple pregnancies, - pregnant women with anemia, - presence of circulatory problems, - cardiovascular disease, - chronic orthopedic disease, - foot-related orthopedic and vascular disease. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital |
Turkey,
Coban A, Sirin A. Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey. Int J Nurs Pract. 2010 Oct;16(5):454-60. doi: 10.1111/j.1440-172X.2010.01869.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Visual Analog Scale (VAS) | The VAS is a single-item scale with a line length of 10 cm. In this line, 0 means "I have no pain," whereas 10 means "worst pain" at the end. Participants were asked to indicate on a 10-point scale how much discomfort they were experiencing | 5 minutes | |
Primary | Evaluation of edema | Measurement was made with a non-flexible tape measure. Care was taken not to compress the tissues during measurement. The patient should be in a comfortable position on his back. The measurement was made with a tape measure, on the medial and lateral malleolar areas for the foot, on the midline of the patella for the knee, and the widest area for the calf and thigh. | 10 minutes | |
Primary | Fatigue Severity Scale (FSS) | It includes the evaluation of the severity and timing of fatigue and the effects of fatigue on daily activities in individuals. It covers the fatigue severity of individuals in the last month. Each question on the scale is scored between 1 and 7 and contains nine questions in total. The arithmetic average of all scores was taken | 5 minutes | |
Primary | Short Form-36 (SF-36) | The test that consists of 36 items and evaluates 8 subheadings assess the level of quality of life. It includes testing of physical and social function, role limitations due to physical and emotional problems, pain, mental health, energy, and finally general perception of health. The second question of the scale covers the 12-month evaluation and the remaining questions cover the last month. The questions are Likert-type, except for the fourth and fifth questions. The score is calculated by reversing items 1, 6, 7, 8, 9a, 9d, 9e, 9h, 11b, 11d of the scale. The score covers the range from 0 to 100. While 0 describes poor health, 100 describes good health | 15 minutes |
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