NCT05128877

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

November 10, 2021

Last Update Submit

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 INTERVENTION

No intervention was made in the control group.

intervention group

EXPERIMENTAL

Progressive relaxation techniques were applied to the intervention group.

Other: relaxation techniques

Interventions

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

intervention group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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
Model Details: This study is a randomized controlled experimental study.
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

Locations