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Completed

NCT Number: NCT06665347

Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome

This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arwa mohamed Abd El-Wahab

Cairo, Egypt

About this study

Premenstrual syndrome (PMS) is characterized by a collection of physical, emotional, psychological, and behavioral symptoms that appear in a cyclic and recurring pattern during the late luteal phase of the menstrual cycle and alleviate within two to four days of menstruation.

Premenstrual Syndrome has a negative impact on young girls' lives, which can lead to reduced work efficiency and quality of work, increased accidents and lack of school attendance. Therefore, there is a need to develop treatment protocols for coping with premenstrual symptoms.

Yoga denotes union and integration and improves biopsychosocial and spiritual wellness. In other words, yoga is a form of mind-body health that combines physical activity with inner-directed mindfulness to achieve self-consciousness through breathing and meditation.

So, this study will be conducted to contribute and add new information that may help the field of physical therapy. It will provide an evidence base for the efficacy of yoga on management of psychological aspect and quality of life in premenstrual syndrome, owing to its low cost, and ease use that may lead to improvement of symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Their ages will be ranged from 18 to 25 years old.
  • Their body mass index (BMI) will be less than 30 kg/m².
  • They will be virgin.
  • They will have regular menstrual cycles.
  • They will suffer from Premenstrual syndrome based on daily record of severity of problems.
  • All women will be conscious and free from any medical disease.

Exclusion criteria

  • Women with the following criteria should be excluded from this study:
  • Women with endocrine disturbance.
  • Endometriosis.
  • Pelvic inflammatory disease.
  • Any pelvic pathology conditions.
  • Women had hysterectomy or ovariectomy.
  • Women use medications as contraceptive pills, pain relief drugs and antidepressant drugs.

Treatment and study plan

Progressive Muscle Relaxation

Other

The participants will receive progressive muscle relaxation for 8 weeks. The muscles of the hand, arm, face, shoulder and neck, chest, abdomen, back, thigh and hip, legs and feet will be contracted and relaxed in sequence. The contraction time is 5 seconds (s), and the relaxation time is 10s.

yoga

Other

The participants will receive yoga for 30 minutes/session, 3 sessions/week for 8 weeks. The session will begin with 5 minutes for warming up. Twenty minutes of wind relieving position (pavanmuktasana), corpse position (savasana), standing side stretch position, seated forward bend (paschimothanasana), cobra position (bhujangasana), and chair position (utkatasana). Five minutes of cooling down.

Primary outcomes

  1. Assessment of premenstrual symptoms

    Time frame: 8 weeks

    It will be assessed using daily record of severity of problems (DRSP). It was used to capture premenstrual symptoms. DRSP contained two parts: symptoms related to menstruation (21 items) and their impairment in daily life (3 items). The symptoms included depression, hopelessness, feelings of worthlessness, increased sleeping, trouble sleeping, feeling overwhelmed, breast tenderness, breast swelling, headache, joint or muscle pain, anger, conflicts or problems with people, anxiety, mood swings, sensitivity to rejection, decreased interest, difficulty concentrating, fatigue, increased appetite, craving specific foods, and feeling out of control All items were rated from 1 ("not at all") to 6 ("extreme"). The higher the score, the more severe the premenstrual symptoms.

  2. Assessment of anxiety

    Time frame: 8 weeks

    The spielberger state trait anxiety inventory will be used to assess anxiety for all participants. It is a 40-item self-report measure of anxiety using a 4-point Likert-type scale for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. its score is ranged from 20-80 on both its two subscales.

    from 20-37 means no or low anxiety, 38-44 means moderate anxiety and 45-80 means severe anxiety.

  3. Assessment of depression:

    Time frame: 8 weeks

    It will be assessed using Beck depression inventory. It is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. its score is ranged from 0-63 and the lowest is zero.

  4. Assessment of Quality of life

    Time frame: 8 weeks

    the SF-36 questionnaire will be used to assess quality of life for all participants. It consists of 36 questions. The SF-36 assesses eight dimensions that include: physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. the score is ranged from 0-100. 1 is for the worse health and 100 for the ideal health.

  5. Assessment of stress level

    Time frame: 8 weeks

    A blood sample will be taken from each woman in the two groups at pre-treatment and post-treatment to measure cortisol levels at 8 AM before breakfast for all cases. it will be used as an objective indication of pain level. its normal values are 5 to 25 mcg/dl or 140-690 nmol/L.

  6. Assessment of pain intensity

    Time frame: 8 weeks

    It will be assessed using the visual analogue scale (VAS). VAS is a simple and frequently used method for the assessment of variations in intensity of pain. In clinical practice the percentage of pain relief, assessed by VAS, is often considered as a measure of the efficacy of treatment. the scale ranges from 0 to 10 with 0 meaning no pain and 10 meaning severe pain

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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