Effect of Massage and Progressive Relaxation Exercises on Primary Dysmenorrhea

NCT ID: NCT04356131

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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experimental group

Students in the experimental group were taught about massage and progressive relaxation exercises (PRE). The phases of the massage and PRE trainings were first explained by being demonstrated by the author on herself. In the meantime, the trainings were video-taped and uploaded to the mobile phones of the students. After the author, each student was made to perform massage and PRE. Both the exercises and massage techniques were daily performed 3 times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes consecutively

Group Type EXPERIMENTAL

progressive relaxation exercises and massage

Intervention Type OTHER

Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.

control group

The students in the control group continued their routines during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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progressive relaxation exercises and massage

Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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EBRU YILDIZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mersin University Faculty of Nursing

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Avcı D.K, Sarı E. Approach to dysmenorrhea and effect of dysmenorrhea on social life and school performance in the university students. Van Medical Journal. 2018; 25(2): 188-193.

Reference Type BACKGROUND

Azima S, Bakhshayesh H.R, Mousavi S, Ashrafizaveh S. Comparison of the effects of reflexology and massage therapy on primary dysmenorrhea. Biomedical Research. 2015; 26 (3): 0976-1683.

Reference Type BACKGROUND

De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.

Reference Type BACKGROUND
PMID: 26841639 (View on PubMed)

Memmott J. The effect of music-assisted progressive muscle relaxation on the self-reported symptoms of women with primary dysmenorrhoea [PhD thesis]. Kansas: University of Kansas; 2009.

Reference Type BACKGROUND

Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.

Reference Type BACKGROUND
PMID: 23158705 (View on PubMed)

İbrahimoğlu Ö, Kanan N. The effect of progressive muscle relaxation exercises after endotracheal extubation on vital signs and anxiety level in open heart surgery patients. Turk Journal Intense Care. 2017; 15(3): 98-106.

Reference Type BACKGROUND

Mackereth PA, Booth K, Hillier VF, Caress AL. Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial. Complement Ther Clin Pract. 2009 Feb;15(1):14-21. doi: 10.1016/j.ctcp.2008.07.002. Epub 2008 Oct 1.

Reference Type BACKGROUND
PMID: 19161949 (View on PubMed)

Other Identifiers

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pain management

Identifier Type: -

Identifier Source: org_study_id

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