Recruitment

Recruitment Status
Completed
Estimated Enrollment
128

Inclusion Criterias

Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
Not have been diagnosed with secondary dysmenorrhea
Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
...
Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
Not have been diagnosed with secondary dysmenorrhea
Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
Regular menstrual cycles (cycle typical range of 21 to 35 days)
Nulliparous

Exclusion Criterias

Women to which it has undergone a surgical procedure for the treatment
Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
...
Women to which it has undergone a surgical procedure for the treatment
Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
Women who suffer from diseases diagnosed added
Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
Use or abuse of drugs or alcohol
Provide skin lesions in the abdominal wall
Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);

Summary

Conditions
Primary Dysmenorrhea
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 30 years
Gender
Only females

Description

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: histo...

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.

Inclusion Criterias

Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
Not have been diagnosed with secondary dysmenorrhea
Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
...
Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom.
Not have been diagnosed with secondary dysmenorrhea
Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
Regular menstrual cycles (cycle typical range of 21 to 35 days)
Nulliparous

Exclusion Criterias

Women to which it has undergone a surgical procedure for the treatment
Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
...
Women to which it has undergone a surgical procedure for the treatment
Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO)
Women who suffer from diseases diagnosed added
Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
Use or abuse of drugs or alcohol
Provide skin lesions in the abdominal wall
Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);

Locations

Sant Joan D'Alacant, Alicante, 03550
Sant Joan D'Alacant, Alicante, 03550

Tracking Information

NCT #
NCT02114723
Collaborators
Not Provided
Investigators
  • Principal Investigator: María I Tomás-Rodríguez, PT, MSC Universidad Miguel Hernández de Elche Study Director: José V Toledo-Marhuenda, PhD Universidad Miguel Hernández de Elche Study Director: Vicente F Gil-Guillén, MD, PhD Universidad Miguel Hernández de Elche Study Chair: Antonio Palazón-Bru, MPH Universidad Miguel Hernández de Elche
  • María I Tomás-Rodríguez, PT, MSC Universidad Miguel Hernández de Elche Study Director: José V Toledo-Marhuenda, PhD Universidad Miguel Hernández de Elche Study Director: Vicente F Gil-Guillén, MD, PhD Universidad Miguel Hernández de Elche Study Chair: Antonio Palazón-Bru, MPH Universidad Miguel Hernández de Elche