The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms
Primary Purpose
Menstrual Discomfort, Relaxation Abnormality, Dysmenorrhea Primary
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
relaxation techniques
Sponsored by
About this trial
This is an interventional supportive care trial for Menstrual Discomfort
Eligibility Criteria
Inclusion Criteria:
- diagnosed with primary dysmenorrhea, have a regular menstrual cycle (28±7 days), menstrual pain greater than 4 cm on the visual analog scale (VAS) women willing to participate in the study voluntarily
Exclusion Criteria:
- Gastrointestinal, urogynecological, autoimmune, psychiatric diseases, other chronic pain syndromes, childbirth, positive pregnancy test, breastfeeding, intrauterine device users, pelvic surgery users, using chronic medication, including oral contraceptives or antidepressants for at least 6 months before the study, irregular menstrual cycle women (with a cycle duration of less than 21 days or longer than 35 days) and women with a pathological history or ultrasonographic imaging showing secondary dysmenorrhea
Sites / Locations
- Cukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
intervention group
Arm Description
No intervention was made in the control group.
Progressive relaxation techniques were applied to the intervention group.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
for pain
Secondary Outcome Measures
menstrual symptom questionnaire
for menstrual symptom discomforts
Full Information
NCT ID
NCT05128877
First Posted
November 10, 2021
Last Updated
September 5, 2022
Sponsor
Cukurova University
1. Study Identification
Unique Protocol Identification Number
NCT05128877
Brief Title
The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms
Official Title
The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effectiveness of Laura Mitchell's relaxation training on primary dysmenorrhea and menstrual symptoms. The study will be carried out on women who have been diagnosed with primary dysmenorrhea, have a regular menstrual cycle (28±7 days), have menstrual pain higher than 4 cm according to the visual analog scale (VAS), and wish to voluntarily participate in the study. The questionnaire created by the researchers will be administered online. The women included in the study will be divided into 2 groups as experimental and control groups by applying randomization using the random drawing method. Laura Mitchell's physiological relaxation training will be applied to the experimental group for 30 minutes on menstrual days during a total of 3 menstrual cycles, accompanied by an online live lesson. The control group will continue their daily routine.
Detailed Description
Dysmenorrhea is a common gynecological complaint in women of reproductive age, characterized by lower abdominal pain that occurs a few hours before or with the onset of menstruation and persists for 1-2 days. It is more common in adolescent and young women. It is divided into primary and secondary dysmenorrhea. The prevalence of primary dysmenorrhea varies between 17-95%. Primary dysmenorrhea, unlike secondary dysmenorrhea, is due to contraction of the myometrium without pelvic pathology. Pain occurs with every menstrual cycle. Generally, cramp-like pain in the suprapubic region may be accompanied by nausea, vomiting, headache, dizziness, sweating, diarrhea, insomnia and syncope . While primary dysmenorrhea is more common in nulliparous, both its severity and incidence decrease with increasing age and parity. Primary dysmenorrhea is pelvic pain that is caused by the natural production of prostaglandins and is not associated with pelvic pathology, and is among the common causes of admission to emergency services. In the pathogenesis of primary dysmenorrhea, it is thought to be associated with prostaglandin production, which increases with vasoconstriction of the uterine blood vessels, leading to uterine contractility and ischemia. Primary dysmenorrhea does not threaten the life of women, but it can affect the quality of life negatively and prevent work and school continuity. There are various relaxation techniques in the literature to reduce the pain and improve the quality of life of women with primary dysmenorrhea. Relaxation techniques are effective and easy-to-apply self-management therapy in reducing the effects of pain, stress, depression, anxiety and mood changes on the individual and in controlling the body. Laura Mitchell's Simple Physiological Relaxation Training is a standard method with the advantages of requiring less concentration, being learned in a short time and showing a rapid effect, and is widely used especially in the field of obstetrics and gynecology. It is known that this technique, which includes diaphragmatic breathing, improves immune system functions and quality of life, and also reduces depression. The aim of this study is to evaluate the effectiveness of Laura Mitchell's relaxation training on primary dysmenorrhea and menstrual symptoms.
METHOD The study will be carried out on women who have been diagnosed with primary dysmenorrhea, have a regular menstrual cycle (28±7 days), have menstrual pain higher than 4 cm according to the visual analog scale (VAS), and wish to voluntarily participate in the study. The questionnaire created by the researchers will be administered online. Before starting the study, the consent of the participants will be obtained via online link. The women included in the study will be divided into 2 groups as experimental and control groups by applying randomization using the random drawing method. Data collection Evaluations were evaluated according to the physical (age, height, body weight, body mass index) and demographic data of the individuals (age at menarche, mean cycle duration, duration of menstruation, pain status, duration of pain, number of pads used on the busiest day, presence of menstrual symptoms experienced during menstruation period). intensity) will be recorded. Individuals will be examined for 5 menstrual cycle follow-ups, 4 of which are consecutive. Pain intensity of individuals will be evaluated with Visual Analog Scale (VAS) and menstrual symptoms will be evaluated with Menstrual Symptom Scale (MSS). To the individuals participating in our study; The 1st day of the 1st menstruation is the 1st evaluation, and the data will be collected with VAS and MSS for both groups, and relaxation training will begin for the experimental group. The 1st day of the 2nd menstruation is the 2nd evaluation, and the data will be collected with VAS and MSS for both groups, and relaxation training will be continued for the experimental group. The 1st day of the 3rd menstruation will be the 3rd evaluation. Data will be collected with VAS and MSS for both groups, and relaxation training will be continued for the experimental group. The 1st day of the 4th menstruation will be the 4th evaluation, and the data will be collected with VAS and MSS for both groups, and the relaxation training will be terminated for the experimental group. They will be free to continue exercising until the seventh menstruation. 1st day of 7th menstruation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Discomfort, Relaxation Abnormality, Dysmenorrhea Primary
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized controlled experimental study.
Masking
Participant
Masking Description
The women included in the study will be divided into 2 groups as experimental and control groups by applying randomization using the random drawing method.
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention was made in the control group.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Progressive relaxation techniques were applied to the intervention group.
Intervention Type
Other
Intervention Name(s)
relaxation techniques
Intervention Description
Mitchell's physiological relaxation technique is based on reciprocal inhibition and involves diaphragmatic breathing and a series of ordered isotonic contractions.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
for pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
menstrual symptom questionnaire
Description
for menstrual symptom discomforts
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosed with primary dysmenorrhea, have a regular menstrual cycle (28±7 days), menstrual pain greater than 4 cm on the visual analog scale (VAS) women willing to participate in the study voluntarily
Exclusion Criteria:
Gastrointestinal, urogynecological, autoimmune, psychiatric diseases, other chronic pain syndromes, childbirth, positive pregnancy test, breastfeeding, intrauterine device users, pelvic surgery users, using chronic medication, including oral contraceptives or antidepressants for at least 6 months before the study, irregular menstrual cycle women (with a cycle duration of less than 21 days or longer than 35 days) and women with a pathological history or ultrasonographic imaging showing secondary dysmenorrhea
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms
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