Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

Hacettepe University

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Other: Biomedical pain education; Other: Pain neuroscience education; Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT06040866

KA-22038

Details and patient eligibility

About

The aim of this study was to compare the effects of biomedical pain education and pain neuroscience education, in addition to routine exercise training, on menstrual pain parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of life in healthy individuals with primary dysmenorrhea.The design of the study is parallel group, randomized study. Individuals will be randomly assigned to one of the pain neuroscience education or biomedical pain education research arms.

In the literature, there is no study comparing the effects of pain neuroscience education and biomedical pain education in primary dysmenorrhea, which is a problem that affects women's lives significantly. It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea.

Full description

The aim of this study was to compare the effects of biomedical pain education and pain neuroscience education, in addition to routine exercise training, on menstrual pain parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of life in healthy individuals with primary dysmenorrhea. The design of the study is parallel group, randomized study. The study sample consists of healthy individuals aged 18 years and older with primary dysmenorrhea symptoms.

Individuals will be randomly assigned to one of the two research arms. In addition to the exercise training, which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the first research arm will be given pain neuroscience education once a week for 2 weeks.

In the second research arm, in addition to the exercise training that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks.

Participants will be evaluated in terms of descriptive measurements and outcome measures 3 times in total, before the applications, immediately after the end of the application period, and 3 months after the end of the applications. The primary outcome measurement parameter of the study was determined as the Visual Analog Scale (VAS) score, which is used to determine the severity of menstrual pain. Secondary outcome measures are menstrual stress level to be evaluated with the Menstrual Distress Questionnaire, somatosensory function status to be evaluated with the Central Sensitization Inventory, pain catastrophizing state to be evaluated with the Menstrual Pain Specific Pain Catastrophizing Scale, pain beliefs status to be assessed with the Pain Beliefs Questionnaire, anxiety/depressive symptom level to be evaluated with Depression Anxiety Stress Scales-21 (DASS-21), quality of life to be evaluated with World Health Organization Quality of Life Scale-Short Form and perception of change to be evaluated by 5-point likert scale.

Sample size calculation was performed with G*Power version 3.1 based on previous study results. In the one-way hypothesis design, it was determined that a total of 32 individuals, 16 individuals in each group, should be included in the study in order to reach 80% power with the calculated effect size difference Cohen's d=0.9 and α=0.05 type 1 error. Considering that there might be a 20% loss of individuals during the study, it was decided to include a total of 38 individuals in the study.

In the literature, there is no study comparing the effects of pain neuroscience education and biomedical pain education in primary dysmenorrhea, which is a problem that affects women's lives significantly. It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being diagnosed with PD by a gynecologist based on the Primary Dysmenorrhea Consensus Guidelines,
• Nulligravid,
• Not having any known disease,
• Regular menstrual cycle (28±7 days),
• Severity of menstrual pain ≥ 4 cm according to VAS in the last 6 months and during the last menstruation,
• 18 years and over,
• Volunteer healthy female individuals who consented to participate in the study, willing to be randomized, will be included.

Exclusion criteria

• Pathological pelvic conditions including endometriosis, chronic pelvic inflammatory disease, adenomyosis, polycystic ovary syndrome, endometrial fibroids/polyps or sexually transmitted diseases,
• History of pelvic or abdominal surgery
• Taking antidepressants, anxiolytics or oral contraceptives,
• Receiving alternative treatment in the last year,
• Individuals using an intrauterine contraceptive device will not be included.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Pain neuroscience education

Experimental group

Description:

In addition to the exercise training (stretching and relaxation exercises), which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks. Participants in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.

Treatment:

Other: Exercise training

Other: Pain neuroscience education

Biomedical pain education

Active Comparator group

Description:

In the biomedical pain education arm, in addition to the exercise training (stretching and relaxation exercises) that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks. Participants in the biomedical pain education arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.

Treatment:

Other: Exercise training

Other: Biomedical pain education