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Clinical Trials/NCT06338254
NCT06338254
Completed
Not Applicable

Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema, and Quality of Life in Pregnant Women: Randomized Controlled Trial

Istanbul Medipol University Hospital1 site in 1 country60 target enrollmentSeptember 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Complications
Sponsor
Istanbul Medipol University Hospital
Enrollment
60
Locations
1
Primary Endpoint
The Visual Analog Scale (VAS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

Aim: 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. Methods: Sixty pregnant women between 24 and 36 weeks of pregnancy were included in the study. Pregnant women were randomly divided into two groups: The percussion massage treatment (PMT) group and the control group. Pregnant women included in the PMT group received a total of 10 sessions of percussion massage therapy, applied to their bilateral medial gastrocnemius, lateral gastrocnemius, peronus longus and tibialis anterior muscles three times a week. No massage therapy was applied to the lower extremities of the pregnant women in the control group. Pain assessment with Visual analog scale (VAS), ankle, knee, and thigh circumference measurements with tape measure, fatigue level with Fatigue Severity Scale (FSS), and quality of life assessment with Short Form- 36 (SF-36) were conducted.

Registry
clinicaltrials.gov
Start Date
September 4, 2022
End Date
June 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

merve yilmaz menek

Principal Investigator

Istanbul Medipol University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The Visual Analog Scale (VAS)

Time Frame: 5 minutes

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

Evaluation of edema

Time Frame: 10 minutes

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.

Fatigue Severity Scale (FSS)

Time Frame: 5 minutes

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

Short Form-36 (SF-36)

Time Frame: 15 minutes

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

Study Sites (1)

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