CClinicalTrials.gg
CompletedNCT05128877Updated Sep 8, 2022

The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms

An interventional study of relaxation techniques in Menstrual Discomfort, Relaxation Abnormality and Dysmenorrhea Primary, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Menstrual Discomfort
  • Relaxation Abnormality
  • Dysmenorrhea Primary

Browse trials for

03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 360 is above the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
360 participants (actual)

Study arms

  • No intervention
    Control group

    No intervention was made in the control group.

  • Experimental
    intervention group

    Progressive relaxation techniques were applied to the intervention group.

    Other: relaxation techniques

Interventions

  • Otherrelaxation techniques

    Mitchell's physiological relaxation technique is based on reciprocal inhibition and involves diaphragmatic breathing and a series of ordered isotonic contractions.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    for pain

    Time frame: 6 months

Secondary outcomes

  1. menstrual symptom questionnaire

    for menstrual symptom discomforts

    Time frame: 6 months

07

Study locations

1 site
  • Cukurova University
    Adana, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05128877
Lead sponsor
Cukurova University
Responsible party
Emir İbrahim IŞIK (Assistant Professor, Cukurova University) — Principal investigator
First posted
Nov 22, 2021
Start date
Jan 3, 2021
Primary completion
Oct 31, 2021
Completion
Dec 31, 2021
Last update
Sep 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion