Clinical trial NCT06338254: Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Edema Leg
Physiotherapy
Keywords: Edema
pain
percussion massage therapy
pregnancy
quality of life
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Visual Analog Scale (VAS)
timeFrame: 5 minutes
measure: Evaluation of edema
timeFrame: 10 minutes
measure: Fatigue Severity Scale (FSS)
timeFrame: 5 minutes
measure: Short Form-36 (SF-36)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.