The Effectiveness of Relaxation Training on Primary Dysmenoreh and Menstrual Symptoms
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 8, 2022
September 1, 2022
10 months
November 10, 2021
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale
for pain
6 months
Secondary Outcomes (1)
menstrual symptom questionnaire
6 months
Study Arms (2)
Control group
NO INTERVENTIONNo intervention was made in the control group.
intervention group
EXPERIMENTALProgressive relaxation techniques were applied to the intervention group.
Interventions
Mitchell's physiological relaxation technique is based on reciprocal inhibition and involves diaphragmatic breathing and a series of ordered isotonic contractions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
January 3, 2021
Primary Completion
October 31, 2021
Study Completion
December 31, 2021
Last Updated
September 8, 2022
Record last verified: 2022-09