Evaluation of Yoga in Controlling Pain Symptoms and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial

Study Design

Study Type Interventional (Clinical Trial)

Primary Purpose Treatment

Allocation Randomized

Intervention Model Parallel Assignment

Masking None (Open Label)

Number of Arms 2

Interventional Study Model Description (opcional) Two-arm randomized parallel-group trial comparing an 8-week online yoga program versus a conventional physical exercise program.

4. Conditions and Keywords

Condition Endometriosis

Keywords

Endometriosis

Chronic pelvic pain

Dysmenorrhea

Dyspareunia

Yoga

Physical exercise

Quality of life

5. Arms and Interventions Arm 1

Arm Type Experimental

Arm Name Yoga

Arm Description Participants assigned to the yoga arm received eight weekly 30-minute online group sessions delivered via videoconference by trained instructors. Each session included meditation, pranayama breathing techniques and a standardized sequence of seated and standing postures targeting relaxation, body awareness, flexibility and pelvic/lumbopelvic muscle balance.

Intervention Type Other

Intervention Name Yoga program

Intervention Description The yoga program consisted of eight 30-minute sessions delivered once weekly via Zoom or Google Meet. Sessions included an initial brief meditation, followed by pranayama techniques (e.g., Prana Shuddhi, Chandra Bhedana, Bhramari) and postures such as Sukhasana, Paschimottanasana, Gomukhasana, Baddha Konasana, Tadasana, Adho Mukha Svanasana, Anjaneyasana and Eka Pada Rajakapotasana, ending with Savasana. Participants were advised not to engage in other structured physical activity during the intervention period.

Arm 2

Arm Type Active Comparator

Arm Name Conventional Physical Exercise

Arm Description Participants assigned to the physical exercise arm received eight weekly 30-minute online group sessions focusing on functional strengthening and stretching of the hip and pelvis, delivered via videoconference by physical educators or physiotherapists.

Intervention Type Other

Intervention Name Conventional physical exercise program

Intervention Description The physical exercise program consisted of eight 30-minute sessions delivered once weekly via Zoom or Google Meet. Each session included four modules: 8 minutes of hip and lumbopelvic warm-up, 8 minutes of bodyweight squats, 8 minutes of strengthening exercises for hip and pelvic stabilizers (gluteus medius, gluteus maximus, tensor fasciae latae, piriformis, adductors/abductors), and 6 minutes of stretching to improve flexibility and muscle relaxation.

6. Outcome Measures Primary Outcome Measures

Use um desfecho primário claro (o artigo trata dor como foco principal). Exemplo:

Change in dysmenorrhea intensity (VAS 0-10)

Time Frame: Baseline (week 0) to week 8

Description: Difference in dysmenorrhea intensity measured on a 0-10 visual analogue scale (VAS), comparing yoga and physical exercise groups. Higher scores indicate more intense pain.

Change in deep dyspareunia intensity (VAS 0-10)

Time Frame: Baseline to week 8

Description: Difference in deep dyspareunia intensity measured on a 0-10 VAS, comparing yoga and physical exercise groups.

Change in non-cyclical pelvic pain intensity (VAS 0-10)

Time Frame: Baseline to week 8

Description: Difference in acyclical pelvic pain intensity measured on a 0-10 VAS, comparing yoga and physical exercise groups.

(Se o PRS exigir 1 primário apenas, escolha só dysmenorrhea VAS como Primary e marque os outros como Secondary.) Secondary Outcome Measures

Change in cyclic bowel symptom intensity (VAS 0-10)

Time Frame: Baseline to week 8

Description: Change in intensity of cyclic bowel symptoms/dyschezia on a 0-10 VAS.

Change in cyclic urinary symptom intensity (VAS 0-10)

Time Frame: Baseline to week 8

Description: Change in intensity of cyclic urinary symptoms/dysuria on a 0-10 VAS.

Change in SF-36 domain scores

Time Frame: Baseline to week 8

Description: Change in eight domains of the Short-Form 36 (functional capacity, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, mental health). Higher scores indicate better quality of life.

Change in EHP-30 domain scores

Time Frame: Baseline to week 8

Description: Change in domains of the Endometriosis Health Profile-30 (pain, control, emotional well-being, social support, self-image, work, sexual relations, medical care, treatment, infertility). Higher scores indicate worse health status.

Patient satisfaction with the intervention (Likert scale)

Time Frame: Week 8

Description: Overall satisfaction with the assigned intervention assessed on a Likert scale questionnaire (e.g., very dissatisfied to very satisfied).

Adherence to the intervention protocol

Time Frame: 8 weeks

Description: Proportion of participants who attended all eight scheduled sessions; reasons for non-adherence (scheduling conflicts, non-response, medical or personal reasons).

7. Eligibility Criteria

Inclusion Criteria

Women aged 18 to 45 years

Confirmed diagnosis of endometriosis by pelvic magnetic resonance imaging, transvaginal ultrasound with bowel preparation, or laparoscopy with histological confirmation

Presence of endometriosis-related pain (dysmenorrhea, deep dyspareunia, non-cyclical pelvic pain, dyschezia, or cyclical dysuria) with minimum intensity ≥3 on a 0-10 scale

Ability to participate in online sessions via videoconference

Provision of written informed consent

Exclusion Criteria

Active malignancy

Known infectious or inflammatory disease

Contraindications to practicing physical activity

Scheduled surgery during the 8-week study period

Initiation of new hormonal therapy during the study period

Age older than 45 years

Refusal or inability to provide informed consent

Sex/Gender: Female

Age Limits: 18 Years to 45 Years

Accepts Healthy Volunteers: No

8. Locations and Contacts

Countries of Recruitment Brazil

Facility 1

Name: Hospital BP - A Beneficência Portuguesa de São Paulo

City: São Paulo

Country: Brazil

Facility 2

Name: Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

City: São Paulo

Country: Brazil

Overall Official / Principal Investigator

Name: Maurício Simões Abrão, MD

Affiliation: Faculdade de Medicina da Universidade de São Paulo

9. Oversight / Ethics

Human Subjects Review Approved

IRB / Ethics Committee Name Research Ethics Committee of BP - Beneficência Portuguesa de São Paulo and the Endometriosis Outpatient Clinic of HCFMUSP

Ethics Approval Number 6.310.906