Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Pain neuroscience education (PNE) has shown positive effects in musculoskeletal conditions but has not yet been studied in women with primary dysmenorrhea. This study aims to evaluate the effect of an online PNE intervention combined with lifestyle recommendations, compared to lifestyle recommendations alone
This randomized controlled trial will compare an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Participants will be randomized (1:1) to either the intervention group (4-week online PNE modules plus lifestyle recommendations) or the control group (lifestyle recommendations only). The program is based on Butler and Moseley's pain neuroscience principles, adapted to menstrual pain. Outcomes will be assessed at baseline and at 6 months. The primary outcome is pain intensity. Secondary outcomes include anxiety, depression, kinesiophobia and pain catastrophizing,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Pain Neuroscience Education (PNE) | Experimental | Participants in this arm will receive an online pain neuroscience education (PNE) program plus usual lifestyle recommendations. The PNE intervention consists of four weekly audiovisual and written modules adapted to the context of primary dysmenorrhea, focusing on the neurobiology and biopsychosocial aspects of pain, with practical strategies to reduce maladaptive beliefs, kinesiophobia, and catastrophizing. |
|
| Active Comparator | Active Comparator | Participants in this arm will receive the usual lifestyle recommendations for primary dysmenorrhea. These recommendations include general advice on healthy habits and self-management strategies typically provided in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNE online + lifestyle recommendations. | Other | Four-week online educational program with audiovisual modules on the neurobiology and biopsychosocial aspects of pain, adapted to women with primary dysmenorrhea. In addition, participants receive usual lifestyle recommendations, including general advice on healthy habits and self-management strategies commonly provided in clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity measured by the 11-point Numeric Rating Scale (NRS) | Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average menstrual pain intensity over the previous cycle, from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity. | pre-intervention and 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) has 14 items, with two subscales: HADS-Anxiety (7 items) and HADS-Depression (7 items). Each subscale ranges 0-21; higher scores indicate greater anxiety/depression. | pre-intervention and 6 months post-intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan Francisco Lisón Párraga, Dr | Universidad Cardenal Herrera CEU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad CEU Cardenal Herrera | Valencia | Valencia-valència | 46006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30312470 | Background | Soderman L, Edlund M, Marions L. Prevalence and impact of dysmenorrhea in Swedish adolescents. Acta Obstet Gynecol Scand. 2019 Feb;98(2):215-221. doi: 10.1111/aogs.13480. Epub 2018 Nov 6. | |
| Background | Butler DS, Moseley GL. Explain Pain. 2nd ed. Adelaide, South Australia: Noigroup Publications; 2013. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D004412 | Dysmenorrhea |
| D000092442 | Kinesiophobia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
Individually randomized, two-arm parallel trial (1:1) comparing an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Randomization will be computer-generated and allocation concealed by an independent researcher. Outcomes will be assessed at baseline and at 6-month follow-up by blinded assessors/analysts. Intention-to-treat analysis will be applied.
Not provided
Not provided
Outcome assessors and data analysts will be blinded to group allocation. Participants and intervention providers will not be masked due to the nature of the educational program. Allocation will be concealed using a computer-generated randomization sequence managed by an independent researcher.
|
| Lifestyle recommendations | Other | Participants in this arm will receive online lifestyle recommendations for four weeks, including general advice on healthy habits and self-management strategies commonly provided in clinical practice for women with primary dysmenorrhea. |
|
| Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11) | The Tampa Scale for Kinesiophobia-11 (TSK-11) has 11 items scored 1 ("strongly disagree") to 4 ("strongly agree"). Total score 11-44; higher scores indicate greater fear of movement/re-injury. | pre-intervention and 6 months post-intervention |
| Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) includes 13 items scored 0 ("not at all") to 4 ("all the time"). Total score 0-52; higher scores indicate greater pain catastrophizing. | pre-intervention and 6 months post-intervention |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |