Istanbul
Istanbul, 34000, Turkey (Türkiye)
NCT Number: NCT07831421
Primary dysmenorrhea can adversely affect pain, sleep, and health-related quality of life in young women. This study will investigate and compare the effects of interferential current (IFC) and Kinesio taping (KT) added to pelvic floor muscle exercise (PFME) in women with primary dysmenorrhea. The study will be designed as a three-arm randomized controlled trial. A total of 60 women aged 18-30 years will be recruited and randomly allocated to one of three groups: PFME+IFC, PFME+IFC+KT, or PFME alone. Pain will be assessed using the Short-Form McGill Pain Questionnaire and a pain body diagram, sleep quality will be evaluated using the subjective sleep quality component of the Pittsburgh Sleep Quality Index, and health-related quality of life will be assessed using the SF-36.
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Notify Me18 year–30 year
Female
Interventional
Not applicable
Istanbul, 34000, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants received training to improve awareness and correct activation of the pelvic floor muscles before beginning the exercise program. One set consisted of 10 rapid and 10 slow pelvic floor muscle contractions. During rapid contractions, participants were instructed to contract and relax the pelvic floor muscles quickly. During slow contractions, they were instructed to gradually increase the contraction, maintain it for 10 seconds, and then slowly relax the muscles.
The pelvic floor muscle exercise (PFME) program was performed 3 days per week, with 3 sessions per day. Over the 8-week intervention period, the number of sets performed during each session was progressively increased from 1 to 10. Exercise positions were also progressively varied and included supine lying, child's pose, sitting, standing, squatting, and bridging. Participants recorded their exercises in exercise diaries, which were reviewed weekly to monitor adherence
Interferential current (IFC) was applied on the first day of the second menstrual cycle to participants allocated to the PFME+IFC and PFME+IFC+KT groups. IFC was administered to the lumbar region using a quadripolar technique with four vacuum or plate electrodes. Each application lasted 20 minutes, with the stimulation frequency set at 90-100 Hz. Treatment was delivered using a Chattanooga Intelect Advanced device. The intervention was performed under standardized conditions to ensure participant comfort.
Kinesio taping (KT) was applied only to participants in the PFME+IFC+KT group. The application was performed on the first day of the second menstrual cycle, with the taping sites individualized according to the pain locations identified on each participant's pain body diagram.
An I-strip was applied to the suprapubic region using the ligament technique at 100% tension. A star-shaped taping technique was applied over the sacral region. For areas of fascial sensitivity, a Y-strip was applied using a fascial correction technique with 25-50% tension, whereas small I-strips were applied over localized tender points using the space correction technique with 25-50% tension. The tape was planned to be replaced every 3 days, with a 1-day tape-free interval before the second application
Time frame: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Pain characteristics were assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The questionnaire consists of 15 pain descriptors, including 11 sensory and 4 affective items. Each descriptor is scored from 0 (none) to 3 (severe), with higher total scores indicating greater pain severity. The validity and reliability of the Turkish version have been established
Time frame: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
The distribution of pain was assessed using a standardized body diagram on which participants marked the anatomical regions in which they experienced pain. For the present study, the total pain body diagram score was calculated as the total number of regions marked as painful.
Time frame: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Subjective sleep quality was assessed using the subjective sleep quality component of the Pittsburgh Sleep Quality Index (PSQI). The PSQI comprises seven components assessing different aspects of sleep, with higher scores indicating poorer sleep quality. The validity and reliability of the Turkish version have previously been established (Ağargün et al., 1996). In the present study, only the subjective sleep quality component was included in the analysis.
Time frame: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Health-related quality of life was assessed using the SF-36 Health Survey. The instrument assesses eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, and general health. The health change item was also evaluated. Domain scores range from 0 to 100, with higher scores indicating better perceived health status. The validity and reliability of the Turkish version have been established
Istanbul Medipol University Hospital
Other
Effects of Interferential Current and Kinesio Taping Added to Pelvic Floor Muscle Exercises in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
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