Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:12 AM
Study NCT ID:
NCT07424859
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Yoga and Conventional Physical Exercise for Pain and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial
Sponsor:
Beneficência Portuguesa de São Paulo
Organization:
Study Overview
Official Title:
Evaluation of Yoga in Controlling Pain Symptoms and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
two-arm randomized parallel-group trial comparing an 8-week online yoga program versus a conventional physical exercise program.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 198728884 | OTHER | beneficiencia portuguesa de são paulo | View |