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

NCT06665347 | Completed

• 1 other identifier: P.T.REC/012/004757
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (6)

• Assessment of premenstrual symptoms

  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.

  8 weeks

• Assessment of anxiety

  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.

  8 weeks

• Assessment of depression:

  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.

  8 weeks

• Assessment of Quality of life

  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.

  8 weeks

• Assessment of stress level

  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.

  8 weeks

• Assessment of pain intensity

  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

  8 weeks

Study Arms (2)

Progressive muscle relaxation group

ACTIVE COMPARATOR

All participants in this group will receive progressive muscle relaxation for 8 weeks

Other: Progressive muscle relaxation

Progressive muscle relaxation and Yoga group

EXPERIMENTAL

All participants in this group will receive the same progressive muscle relaxation plus yoga for 8 weeks.

Other: Progressive muscle relaxation; Other: Yoga

Interventions

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.

Progressive muscle relaxation and Yoga group; Progressive muscle relaxation group

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.

Progressive muscle relaxation and Yoga group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Arwa mohamed Abd El-Wahab

Cairo, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Autogenic Training; Yoga

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Hossam Al Din Kamel, Professor

  Al-Azhar University

  STUDY DIRECTOR

• khadyga Abdul Aziz, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 2, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2024-10

Locations

EG (1)