Primary Dysmenorrhea Clinical Trial
Official title:
Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
The aim of this study is to assess the analgesic efficacy of self-applied Medical Taping
Concept in the treatment of primary dysmenorrhea .
To evaluate this effect, a total of 128 students from the University Miguel Hernández , with
the following inclusion criteria, participated in this study: history of menstrual pain,
aged between 18 and 39 years who have performed a gynecological check in the last 18 months
and who have been diagnosed with any kind of primary dysmenorrhea.
A preliminary survey to identify valid students was made. Thereafter the participants were
separated into two different groups (intervention group and placebo group) in order to
request the completion of three questionnaires about the characteristics of menstrual pain
and other demographic data for the next two menstrual cycles before the intervention. One
survey included a graphic scale so the students could mark the start and the end of the
symptoms associated with the menstrual cycle.
After that the principal researcher will interviewed with the participants to show them the
correct auto-application of the menstrual bandage and placebo. Each students group will
receive a triptych with information and pictures to the correct application of the adhesive
strips.
Finally, during two new menstrual cycles, the participants will answer the same
questionnaires to assess symptoms and menstrual pain while being worn adhesive strips (3
pieces of Kinesio tape - 20 cm x 5 cm Tape Cure ®-, applied to the abdominal and lower back,
in the intervention group; 2 pieces of Cross Tape ® 2.5 cm x 2 cm -, in the hip joint, in
the placebo group. Participants may do personal hygiene during the days of the menstrual
cycle with their adhesives strips placed on oneself.
The size sample will be 128 girls. Differences will be contrasted in comparison of means
(quantitative improvement, with an ANOVA) to evaluate the intervention. 18 girls were
randomly chosen to obtain an estimation of the contrast parameters considered (means and
standard variations). With this size sample and a significance of 5%, the investigators will
have a power for the total sample for the contrasts of 80%.
To describe the variables, the investigators will use frequencies (absolute and relative)
for the qualitative variables. For the quantitative variables, the investigators will use
means plus standard variations.
To verify the homogeneity of the randomization the investigators will use tests based on the
X2 (Pearson or Fisher) and t-test. The same procedure will be used to verify that the
participants who quit the study have similar characteristics as those who remain.
The improvement will be analyzed quantitatively using ANOVA test. Dependent variable: pain
after the intervention. Independent variables: pain before the intervention, changes in
pharmacological therapy and intervention group. In the event of significant differences in
the ANOVA models the investigators will use the Tukey post-hoc test, in order to determine
where the differences exist between the two groups.
Qualitatively, the investigators will assess the improvement by calculating indicators of
clinical relevance: relative risk (RR), absolute risk reduction (ARR), relative risk
reduction (RRR), and number needed to treat (NNT).
All the analyses will be made at a significance of 5%. The confidence intervals (CI) will be
calculated for the most relevant parameters. The analyses will be done using IBM SPSS
Statistics 19.0.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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