Breathing Exercises on Depression in Postmenopausal Women

Not Applicable

Not yet recruiting

• Conditions: Postmenopausal; Depressive Symptom; Breathing Exercises

• Registration Number: NCT06741384
• Lead Sponsor: Middle East University

Brief Summary

Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women

Detailed Description

Sixty postmenopausal women will be sourced from the Obstetrics \& Gynecology outpatient clinic at El Mahalla El Kobra general hospital in Egypt, with referrals from gynecologists. Patients will be randomly assigned into two groups.

Study group: It will include 30 women participating in diaphragmatic breathing plus aerobic training.

Control group: It will include 30 women participating in aerobic training.

At baseline and poststudy, the following outcomes will be assessed:

1. Depression (Beck Depression Inventory II scale).

2. Sexual function (female sexual function index questionnaire).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-20
• Study Start: 2024-12-26
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Minimum of 3 years after menopause.
• Mild to moderate depression.
• Mild to moderate sexual dysfunction.
• Their ages will be ranged from 45 to 60 years old.
• Their BMI will be less than 30 kg/m2.

Exclusion Criteria

• Prolapse of the pelvic organs.
• Pelvic tumors.
• Vaginal infections.
• Musculoskeletal/ neurological limitations to exercise.
• Psychiatric disorders.
• Unstable cardiovascular conditions.
• Diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression	At baseline and after 8 weeks	The second edition of Beck depression inventory scale will be scored. The second edition of Beck depression inventory scale consists of 21- items. Item scores ranging from 0 to 3 are combined to produce a total score that ranges from 0 to 63 using the cumulative scoring technique. Elevated scores suggest a more severe level of depression.

Secondary Outcome Measures

Name	Time	Method
Sexual function	At baseline and after 8 weeks	Female sexual function index questionnaire will be scored. The female sexual function index questionnaire is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function. The 19 items of the female sexual function index questionnaire use a 5-point scale ranging from 1 to 5 with higher scores indicating greater levels of sexual functioning on the respective item. Total scores of 26.5 or lower characterize sexual dysfunction.