Different Exercise Training Programs in University Students with Primary Dysmenorrhea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorHasan Kalyoncu University
About this trial
Dysmenorrhea is severe lower abdominal pain in women during menstruation. The pain is usually cramping and can radiate to the thighs or lower spine. Lower abdominal pain may be accompanied by vomiting, headache, back pain, diarrhea, fatigue, etc. Depending on the pathophysiology, dysmenorrhea is classified into two types: primary and secondary. Primary dysmenorrhea (PD) is menstrual pain associated with normal ovulatory cycles in the absence of pelvic pathology and a clear physiologic etiology and is most commonly seen in adolescents and young adults. There are numerous studies on PD in the literature, but there is still a lack of studies on which of the non-pharmacologically recommended exercise and other methods is more effective on dysmenorrhea symptoms, sleep and quality of life for individuals with this problem. Different exercise intensities may affect PD symptoms through different mechanisms. Moderate to high intensity exercise may reduce pain by increasing anti-inflammatory cytokines, whereas less intense exercise, such as yoga, affects pain levels by decreasing cortisol levels. The lack of research on which exercise training is more effective in PD individuals was considered as a limitation. In the light of this information, the aim of the investigators study is to compare the effects of different training techniques on dysmenorrhea symptoms, sleep and quality of life in PD treatment and to present the preferability of these techniques based on evidence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Nulliparous female university students aged 18-25 years who volunteered to participate in the study, met the criteria specified in the PD Consensus Guidelines and were diagnosed with PD by a gynecologist
Individuals with a body mass index (BMI) between 18-35
Individuals with a regular menstrual cycle (28 ± 7 days)
Individuals with menstrual pain Visual Analog Scale (VAS) score of 4 cm or higher for the last 6 months
Disqualifiers
Gastrointestinal, urogynecologic, autoimmune, psychiatric, neurological diseases or other chronic pain syndromes
Having given birth and/or being pregnant
Intrauterine device users
Pelvic surgery patients
Trial design
Design model
Parallel
Treatments tested in this trial
Basic Body Awareness Therapy
Other interventionIn TBFT sessions, physiotherapists improve the patient's contact with "self" by focusing on basic movement principles while performing simple daily movements such as lying, sitting, standing, walking, use of sound and massage. Mental awareness, postural balance and free breathing are considered key elements. The patient is invited to explore and integrate flow, rhythm and intentionality in coordinated movements in relation to time, space and energy. TBFT is practiced 2 days a week, 60 minutes, 5-12 weeks, depending on the patient.
High Intensity Interval Training
Other interventionTabata exercise protocol is an 8 repetition training program with 20 seconds of work and 10 seconds of rest. Warm-up and cool-down exercises of 5 minutes each should be done to prevent injuries and negativities. Although the application varies according to the patient, YŞİA is applied 2 days a week, 15-30 minutes, in processes ranging between 2-12 weeks.
Classic Exercise and Lifestyle Tips
Other interventionClassical Exercise (CE) and Lifestyle Recommendations (LSR), Classical exercises used in PD include abdominal, pelvic floor muscles, hip flexors, whole body stretching. Non-pharmaceutical strategies for pain management in LRS include adopting relaxation (rest, warm-up, massage, music, etc.), antalgic positions, and distraction techniques. Common techniques that facilitate relaxation and thus reduce pain include physical rest, hot showers, various heat applications such as thermal seed bags, electric blankets, and drinking hot herbal teas such as chamomile tea.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Basic Body Awareness TherapyActive comparator 1 intervention
Group B: High Intensity Interval Training (HIIT)Active comparator 1 intervention
Group C: Classical Exercise (CE) and Lifestyle Recommendations (LSS)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sociodemographic information
Sociodemographic information, physical and other medical information about the individuals' age, weight and height will be combined to report BMI in kg/m\^2 and general information about menstrual symptoms and cycles were recorded.
Time frame
Two months2
Menstrual Symptom Scale
The scale consists of 22 items and is five-point Likert type. Items 1-13 belong to "Negative effects/somatic complaints" subdimension, items 14-19 belong to "Menstrual pain symptoms" sub-dimension and items 20-22 belong to "Coping methods" subdimension. The Menstrual Symptom Scale score is calculated by averaging the total score of the items in the scale. Participants are asked to assign a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The scale has three subdimensions. The score obtained from the subscales is calculated by averaging the total score of the items in the subscales. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstruation.
Time frame
Two months3
The Menstrual Attitude Questionnaire
The Menstrual Attitude Questionnaire, is in Likert format and is rated on a scale from 1 to 7. The reliability coefficient of the original scale ranges from 0.95 to 0.97. In the Menstrual Attitude Questionnaire, higher average scores from the items, subgroups, or the overall scale indicate a "positive" attitude towards menstruation.
Time frame
Two months4
Evaluation of Quality of Life Short Form-12
Evaluation of Quality of Life Short Form-12: This questionnaire was used to evaluate quality of life, which includes 12 questions about eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Scoring uses the RAND system from zero to 100. The score of each domain is obtained by aggregating the question scores in every domain and dividing the resulting number by the number of questions in the same domain. A higher score indicates better quality of life.The validity and reliability of the questionnaire are approved
Time frame
Two monthsSecondary outcomes
1
Information About Menstruation
To determine characteristics related to menstruation,if use of medication during menstruation, including the name, dose, amount, and timing of the medication. Additionally, individuals were assessed for the presence and severity of systemic symptoms related to menstruation.The severity of these symptoms was rated as follows: 0: None, 1: Mild, 2: Moderate, 3: Severe. This evaluation was conducted on the first day of the 1st, 2nd, and 3rd menstruation cycles.
Time frame
Two months2
Short-form McGill Pain Questionnaire
A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Time frame
Two months3
Pittsburgh Sleep Quality Index
The PSQI evaluates sleep quality and disturbances over a one-month period and consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score of each component ranges 0-3 and the global score is the sum of scores for these seven components with a range of 0-21. The global score of more than 5 indicates poor sleep quality. Developers have suggested that a global PSQI score \> 5 yields a diagnostic sensitivity of 89.6% and a specificity of 86.5% in distinguishing patients with sleep problems from healthy controls in their validation study.
Time frame
Two months4
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer.
Time frame
Two monthsSponsors and contacts
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Source ClinicalTrials.gov
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