Clinical trial NCT04356131: Effect of Massage and Progressive Relaxation Exercises on Primary Dysmenorrhea
Official title: The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms of Students With Primary Dysmenorrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhoea
Massage
Progressive relaxation exercises
Pain
Menstrual symptom
Randomized controlled trial
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was done experimentally in pre-test and post-test design and randomized controlled model among students with PD.

The sample size was calculated with power analysis. According to calculations, it was found that 58 students were enough for sampling through 95% of power value, 0.05 of confidence interval and 0.88 of effect size. Students who were determined to meet sampling and inclusion criteria through questionnaire and accepted to participate in the study were assigned into the experimental and control groups through randomization.

During the follow-up of the three menstruation periods, the number of groups was increased in case of drop-out and 100 students were included. However, the study was completed with a total of 97 students -50 students for the experimental group and 47 students for the control group- because 3 students of the control group withdrew from the study in the second month.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on pain, sweating, fatigue, and gastrointestinal and central nervous system signs. So, it can be asserted that when applied together, massage and progressive relaxation exercises could be more effective in reducing menstrual symptoms than applying them separately.

Detailed description: Dysmenorrhea is one of the most frequent problems during menstruation and described as periodic and painful pelvis menstruation among women at reproductive age. It is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea (PD) is defined as suprapubic pelvis pain with cramps that begin a couple hours before menstrual bleeding, after menstrual bleeding, or during the last 12-72 hours of menstruation and occur repeatedly without organic pathology. PD is associated with an increase in prostaglandin production in the endometrium, which causes pain by increasing uterine contractions in the suprapubic region. According to De Sanctis et al., PD prevalence varies between 16% and 93%. It is often seen with sweating, fatigue, gastrointestinal system signs (lack of appetite, nausea, vomiting, diarrhea), and central nervous system signs (dizziness, headache, syncope, and lack of concentration). These symptoms that occur just before or just after menstrual bleeding among women with normal pelvic anatomy may prevent them from attending school and work or joining social activities. Secondary dysmenorrhea is defined as menstrual pain caused by a pathology in the pelvis such as endometriosis. If a patient has pain for 3-6 months, a more comprehensive evaluation of chronic pelvic pain should be performed to evaluate the potential etiologies of secondary dysmenorrhea.

The international literature includes oral contraceptive, nonsteroidal anti-inflammatory, and sedative drugs for the treatment of primary dysmenorrhea. However, the fact that some of these drugs cause side effects such as indigestion, headache, drowsiness, and substance addiction causes individuals to remain indifferent to them. In Turkey, it is reported that women prefer their family members as the first source of information and therefore use individual methods (massage, herbal teas, hot application, lying down, sweet food consumption, etc.) rather than pharmacological treatments due to cultural differences in coping with PD. Complementary and integrated therapy approaches, which are widely used all over the world today, have become common in coping with gynecological disorders among women in recent years. Some studies state that PD can be cured using such complementary therapies as essential oil acids, vitamins, acupuncture, herbal medicines, aromatherapy, reflexology, acupressure, massage, sports, and exercise. However, ACOG emphasizes that although these methods are frequently used by patients, they have not been studied enough yet, and mostly supports the use of exercise, high-frequency transcutaneous electrical nerve stimulation, and topical heat to help manage dysmenorrhea symptoms. Research on PD has applied massage and exercise practices using different application protocols. Studies on massage applications have examined the effect of inhaling herbal essential oils alone or together with massage. Research solely on exercise has examined the effectiveness of long-term and regular exercise, although with various practices. However, it can be said that massage and progressive relaxation exercises are more advantageous than other methods because they are easy, economical, and can be applied without the need for someone else.

Massage intensifies the blood flow in the area of application and reduces muscle tension. It also increases endorphin secretion and raises the pain threshold. Relaxation exercises, on the other hand, provide a decrease in sympathetic activity, an increase in parasympathetic activity and consequently a widening of the peripheral vessels, an increase in blood flow in the blood vessels, and a decrease in muscle tension and pain perception. Moreover, it has been reported that pain, anxiety, and depression symptoms decrease as a result of the decrease in the activation of the sympathetic nervous system, thanks to the deep breathing exercises performed during PRE. Therefore, it is predicted that massage combined with PRE will be beneficial in PD management. In this sense, this study was conducted to examine the effect of massage and PRE together on pain severity and other menstrual symptoms in PD treatment.

The literature includes no studies on the use of massage and PRE together in PD management. Therefore, the aim of the current study was to examine the effect of massage and PRE together on pain intensity and other menstrual symptoms in the management of PD.

Eligibility criteria: Inclusion Criteria:

* Being older than 18 years,
* Having a dysmenorrhea pain intensity score ≥4 according to Visual Analog Scale (VAS),
* Having no previous pregnancy experience,
* Having no disease that leads to dysmenorrhea,
* Using no hormonal contraception or intrauterine device,
* Having a menstruation period of 3-8 days and a menstrual cycle of 21-35 days,
* Having no systemic-chronic disease or physical/mental health problems that prevent/restrict massage or exercise,
* Volunteering to participate in the study.

Exclusion Criteria:

* Being younger than 18 years
* Having a dysmenorrhea pain intensity score ≤ 4 according to Visual Analog Scale (VAS),
* Having previous pregnancy experience,
* Having disease that leads to dysmenorrhoea (endometriosis, ovarian cysts/tumors, pelvic infection disease, myoma/uterus tumor, uterus polyp, asherman syndrome, infection),
* Using hormonal contraception and intrauterine devices,
* Not to present a menstruation period that lasts 3-8 days and menstrual cycle of 21-35 days,
* Having a systemic and chronic disease (diabetes, heart diseases, vein diseases, circulatory disorders, varicosis, blood diseases, etc.),
* Having any physical/mental health problems that prevent/restrict massaging and exercising,
* Not to be voluntary to join the study.

Primary outcomes:
measure: Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form".
timeFrame: 1 day
Secondary outcomes:
measure: Students' Menstruation Period Pain as assessed by The short-form McGill Pain Questionnaire.
timeFrame: 28 day
measure: Students' Menstruation Period Menstrual Symptoms as assessed by Daily Symptom Rating Scale.
timeFrame: 28 day
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Faculty of Nursing
Study officials:
References:
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