This study was a randomized, controlled, and single blind (evaluator) trial, registered in ClinicalTrials.gov (NCT04856280). The study was approved by the Institutional Non-Invasive Ethics Committee (Approval number: 10840098-604.01.01).
Participants were recruited among healthy young adults who have dysmenorrhoea attending Uskudar, Istanbul, Turkey. This study was concluded between October 2019-March 2020.
Forty five women with dysmenorrhea aged 15-30 years who fulfilled the inclusion criteria were included in the study. The sample size was determined using the G*power sample size calculator . The required sample size was 14 for each group with a 80% power (α=0.05, β=0.20). We aimed to enroll at least 40 participants considering the drop-outs.
Patients who met the inclusion criteria were included in the study. The inclusion criteria defined as being aged between 15-30, being virgin, having started the menstrual cycle and continuing the cycle, taking ≥5 points from Visual Analog Scale during menstrual cycle. The exclusion criteria defined as having endometriosis and adenomyosis, myoma uteri and endometrial polyp, having a pelvic infection, using an intrauterine device, having venous congestion in the internal genital organs. All participants had signed a written informed consent form, and the study has been conducted in accordance with the principles of the Declaration of Helsinki.
All participants were evaluated before and after the interventions. The evaluations were carried out in a room at the respective institution and involved the collection of information regarding sociodemographic and anthropometric datas, Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), physical and mental sub parameters of Beck Depression Scale (BDS), and Short Form-36 (SF-36) before and after treatment.
Demographic Information Form: Demographic Information Form was prepared to record the sociodemographic characteristics of healthy individuals included in the study.
Mcgill Pain Questionnaire: This questionnaire consists of 11 words to determine the sensory state of pain, and 15 words related to the quality of pain in total, consisting of 4 different words to determine its affective aspect. In addition, the pain intensity felt during measurement is measured by Visual analog Scale (VAS), and the total pain intensity assessed is measured by a 6-point Likert-type scale. In this scale, “0” is defined as no pain, “5” is defined as unbearable pain . The validity and reliability of the questionnaire in Turkish was concluded by Yakut et al. .
Menstrual Attitude Scale: The scale was prepared based on the theory that there may be versatility in menstrual attitudes, positive attitudes may occur as well as negative, and expectations that may occur according to physiological and emotional symptoms before or during menstruation may be effective in the behaviors shown in this period. MAS is a scale developed by applying to high school and university students, can be self-answered, easy to apply, and contains 33 items to measure the positive and negative attitudes of menstruation. MAS has 5 subscales such as the menstruation as a weakening phenomenon (12 no pain, unbearable pain, 32 items), the menstruation as a disturbing phenomenon (6 items), the menstruation as a natural phenomenon (5 items), the predicting/sensing that there will be menstruation (5 items), and the denying the effects of menstruation (7 items). The scale is of 5-point Likert type. The high average score of the subscales shows that the attitude towards menstruation is “positive” .
Beck Depression Scale: It is a test containing 21 items that the person evaluates himself. It measures the symptoms seen in depression such as emotional, cognitive and motivational. The items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms .
The total score of all answers is calculated as follows:
- 0 to 9 points: Minimally depressive symptoms
- 10 to 16 points: Mild depressive symptoms
- Between 17 and 29 points: Moderate depressive symptoms
- Between 30 and 63 points: Severe depressive symptoms
Short Form 36: SF-36 is a 36-question self-assessment scale consisting of eight subscales. This scale is based on physical function (10 items), role limitations due to physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100 and “0” indicates the lowest and “100” shows the best quality of life .
The participants were randomly divided into 3 groups using Microsoft Excel ‘RAND(WS)’ function as the kinesiological taping (KT) group (n=15), the aerobic exercise (AE) group (n=15) and the control group (n=15). At the beginning of the study, 45 participants were included in the study, but according to exclusion criteria, one woman was excluded from the study. The study was completed with 44 participants. The allocation was shown in CONSORT FlowChart Diagram (Figure 1).
In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes. No application was made to the control group.
Kinesiological Taping Protocol
6 sessions of taping was applied to the kinesiological taping group, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. Using the KT ligament technique, it was applied to the supra pubic region with 100% tension in order to reduce contraction in the uterus (Figure 2 and 3).
In the AE group, walking and climbing stairs were given during the menstrual cycle, 45 minutes session per day, 3 days a week over 3 weeks. The exercise protocol consists of 5 minute warm up, 35 min AE and 5 minute cool-down exercises. Warm-up and cool-down exercises include an active range of motion (ROM) exercises for upper and lower extremity. Aerobic exercise includes 30 min of moderate walking and climbing stairs. The aerobic exercise was performed in accordance with the definition of moderate-intensity exercise of the World Health Organization; “It was given to the participants that during moderate exercise, the individual should walk with a tempo in a way that he can speak but cannot sing” .
Statistical Package for Social Sciences Software version 25.0 (SPSS Inc, Chicago, USA) was used for statistical analyses. Descriptive datas were expressed as means and standard deviations, or as number and proportion as appropriate. The normal distribution of the variables was determined by the Kolmogorov-Smirnov Within-group datas were assessed by the Paired-Samples T Test. Two-Way Repeated Measure ANOVA Test was used to assessed between group datas, Time*Group interactions, and Post-Hoc Tests. The significance value was accepted as p<0.05.