Effects of Yoga on Balance, Cognition, Posture, and Body Awareness in Premenstrual Syndrome (PMS)

NCT06785766 | Enrolling By Invitation

• 1 other identifier: Yoga for Premenstrual Syndrome
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Premenstrual syndrome (PMS) is characterized by a combination of cognitive, somatic, behavioral, and emotional disorders that occur during the late luteal phase of the menstrual cycle, resolve rapidly after menstruation, and can be severe enough to disrupt daily activities. When reviewing the literature, studies examining the effects of yoga-based exercises on premenstrual syndrome appear to be quite limited. Our aim is to raise awareness among professionals working in this field in our country, contributing to the reduction of symptoms and improvement of the quality of life of individuals with premenstrual syndrome.

Conditions

Premenstrual Syndrome-PMS

Keywords

Quality of life; Premenstrual Syndrome; Yoga; Pain; Cognitive Function; Body Awareness

Outcome Measures

Primary Outcomes (2)

• Premenstrual Syndrome Scale (PMSS)

  The Premenstrual Syndrome Scale (PMSS), developed by Gençdoğan (2006) based on DSM-III and DSM-IV-R criteria, is a 44-item, five-point Likert-type scale designed to diagnose PMS and assess symptom severity. Items are rated based on the condition "during the week before menstruation," with responses ranging from 1 - Not at all to 5 - Always.The scale includes nine subdimensions:Depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, bloating. The total score ranges from 44 to 220, with higher scores indicating more severe symptoms. Scores of 132 or higher (≥50% of the maximum) indicate the presence of PMS.

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

• Body Awareness Questionnaire

  This questionnaire aims to determine the sensitivity level of body composition, either normal or abnormal, and consists of four subgroups (Changes in body processes, Sleep-wake cycle, Prediction at the onset of illness, Prediction of body responses) with a total of 18 statements. Participants are asked to rate each statement with a score between one and seven. The assessment is scored based on the total points, with higher scores indicating better body sensitivity. The original version of the questionnaire was developed by Shields et al. in 1989. The validity and reliability study for the Turkish version was conducted by Karaca (2017), and the internal consistency coefficient was found to be 0.91.

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

Secondary Outcomes (9)

• Demographic Information Form Section C

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

• Y Balance Test

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

• PostureScreen Mobile Application

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

• N-Back Test

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

• Assessment of Grip Strength

  The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).

Study Arms (2)

Intervention Group

EXPERIMENTAL

The "Intervention Group" will receive an 8-week yoga-based exercise program, consisting of 60-minute sessions held twice a week. Each session includes a 5-minute warm-up, 5 minutes of breathing exercises (pranayama), 40 minutes of yoga postures (asana), 5 minutes of deep relaxation (Savasana), and 5 minutes of meditation. The program will be facilitated by a physiotherapist who will demonstrate the poses, observe participants, and provide verbal instructions for adjustments as needed. The yoga postures will be adapted using props such as blocks, straps, blankets, pillows, and chairs, based on individual needs and abilities. The difficulty of the sessions will gradually increase over the 8 weeks, with the yoga flows being adjusted to match weekly themes and participants' progress.

Behavioral: Yoga-Based Exercise Program

Control Group

NO INTERVENTION

The "Control Group" will not receive any specific intervention during the study period. Participants in this group will be asked to continue their routine activities without starting any new exercise programs. They will be advised to engage in 30-minute walking sessions three times a week as part of their regular routine. No yoga or additional structured exercise will be provided. After the 8-week waiting period, participants in the control group will be given the option to join the yoga-based exercise program if they wish.

Interventions

Yoga-Based Exercise Program BEHAVIORAL

This intervention is an 8-week yoga-based exercise program conducted with 60-minute sessions twice a week. The program aims to improve flexibility, mobility, and overall well-being. Each session consists of 5 minutes of warm-up, 5 minutes of breathing exercises, 40 minutes of yoga postures, 5 minutes of deep relaxation, and 5 minutes of meditation. The intervention adapts yoga postures based on participants' individual needs, offering a flexible approach. The difficulty of the yoga flows gradually increases over the 8 weeks. When necessary, postures are adapted using props like blocks, straps, blankets, and chairs. A physiotherapist guides participants, demonstrating correct techniques and providing verbal instructions. This program combines yoga, breathing exercises, and meditation to enhance physical and mental well-being, promoting long-term health benefits.

Also known as: 8-Week Yoga Program, Yoga for Health and Wellness, Yoga Therapy for Active Living

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of premenstrual symptoms (scoring 132 or above on the Premenstrual Syndrome Scale (PMSS)),
• Aged 18 and above,
• Able to read and write,
• Willing to participate voluntarily in the study and have signed the informed consent form,
• No problems with cooperation and communication,
• Normal menstrual cycle length (21-35 days) in the past 3 months,
• Not having taken any medications or mineral supplements during the last three menstrual cycles.

You may not qualify if:

• Amenorrhea
• Being in the menopausal period
• Pregnancy
• Having given birth
• A diagnosis of cancer
• Having previously practiced yoga
• Having exercise intolerance
• Having received hormone replacement therapy
• Having been enrolled in a physiotherapy program in the past 3 months
• Regular exercise within the past 3 months
• Having musculoskeletal, neurological, serious cardiopulmonary, chronic systemic, psychiatric, balance and coordination, or vestibular system disorders that may prevent participation in exercise

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Siirt University

Siirt, Si̇i̇rt, 56100, Turkey (Türkiye)

Location

Related Publications (5)

• Hopkins BB, Vehrs PR, Fellingham GW, George JD, Hager R, Ridge ST. Validity and Reliability of Standing Posture Measurements Using a Mobile Application. J Manipulative Physiol Ther. 2019 Feb;42(2):132-140. doi: 10.1016/j.jmpt.2019.02.003. Epub 2019 Apr 15.

  PMID: 31000345 BACKGROUND

• Colucci DB, Fiore JF Jr, Paisani DM, Risso TT, Colucci M, Chiavegato LD, Faresin SM. Cough impairment and risk of postoperative pulmonary complications after open upper abdominal surgery. Respir Care. 2015 May;60(5):673-8. doi: 10.4187/respcare.03600. Epub 2015 Feb 10.

  PMID: 25669217 BACKGROUND

• Aoki M, Suzuki M, Suzuki S, Takao H, Okayama H. Cognitive function evaluation in premenstrual syndrome during the follicular and luteal phases using near-infrared spectroscopy. Compr Psychoneuroendocrinol. 2022 Feb 4;10:100117. doi: 10.1016/j.cpnec.2022.100117. eCollection 2022 May.

  PMID: 35755198 BACKGROUND

• Friden C, Hirschberg AL, Saartok T, Backstrom T, Leanderson J, Renstrom P. The influence of premenstrual symptoms on postural balance and kinesthesia during the menstrual cycle. Gynecol Endocrinol. 2003 Dec;17(6):433-9. doi: 10.1080/09513590312331290358.

  PMID: 14992161 BACKGROUND

• Kroll-Desrosiers AR, Ronnenberg AG, Zagarins SE, Houghton SC, Takashima-Uebelhoer BB, Bertone-Johnson ER. Recreational Physical Activity and Premenstrual Syndrome in Young Adult Women: A Cross-Sectional Study. PLoS One. 2017 Jan 12;12(1):e0169728. doi: 10.1371/journal.pone.0169728. eCollection 2017.

  PMID: 28081191 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Pain

Interventions

Yoga; Health

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Population Characteristics

Study Officials

• Özlem ÇİNAR ÖZDEMİR, Prof. Dr., PhD

  İzmir Democracy University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: The women included in the study will be randomized and divided into two groups (arms), 30 participants in each group, as intervention and control groups. Both groups will receive information training at the beginning of the study. The exercise program for the intervention group will consist of 60-minute yoga-based exercise sessions, conducted twice a week for 8 weeks. Additionally, both groups will be instructed to perform a 30-minute walk three times a week.The groups will be formed based on participants' availability, and 8-week yoga flows with gradually increasing difficulty will be applied, based on themes set for each week. Participants assigned to the control group will be asked to continue their routine activities and not to start a new exercise program during the study period. After the second evaluations are completed, the participants in the control group will be offered the opportunity to participate in the yoga program.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: February 15, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)