NCT05396976

Brief Summary

Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 28, 2022

Last Update Submit

May 27, 2022

Conditions

Keywords

Premenstrual SyndromeYogaMuscle Relaxation Exercise PracticesDepression, anxiety and stress

Outcome Measures

Primary Outcomes (2)

  • Premenstrual Syndrome Scale

    Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdoğan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points.

    10 weeks

  • Depression Anxiety Stress Scale-21

    The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sarıçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress.

    10 weeks

Study Arms (4)

Yoga Group

EXPERIMENTAL

Yoga practice will be done two days a week for 10 weeks.

Behavioral: Yoga and Muscle Relaxation Exercise Practices

control group

NO INTERVENTION

no intervention

Muscle Relaxation Exercise Practices Group

EXPERIMENTAL

Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Behavioral: Yoga and Muscle Relaxation Exercise Practices

Yoga and Muscle Relaxation Exercise Practices Group

EXPERIMENTAL

Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Behavioral: Yoga and Muscle Relaxation Exercise Practices

Interventions

Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Muscle Relaxation Exercise Practices GroupYoga GroupYoga and Muscle Relaxation Exercise Practices Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale students over the age of 18
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old

You may not qualify if:

  • Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

Location

Related Publications (1)

  • Abic A, Dag-Canatan S, Er-Korucu A, Aksoy-Can A. The effects of yoga and progressive muscle relaxation exercises on premenstrual syndrome: a randomized controlled trial. Women Health. 2024 Mar;64(3):261-273. doi: 10.1080/03630242.2024.2314524. Epub 2024 Feb 11.

Related Links

MeSH Terms

Conditions

Premenstrual SyndromeDepressionAnxiety Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Arzu Abiç, PhD

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Sinem Dağ Canatan, MsC

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Aslı Er Korucu, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR
  • Ahu Aksoy Can, PhD

    Mersin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinem Dag Canatan, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof. Dr

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 31, 2022

Study Start

June 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 7, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations