Clinical trial NCT06040866: Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
Official title: Effects of Pain Neuroscience Education or Biomedical Pain Education With Exercise Training in Primary Dysmenorrhea: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a parallel group randomized clinical trial. In this study, individuals were planned to be randomly assigned to either Pain Neuroscience Education combined with exercise training or Biomedical Pain Education combined with exercise training groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of menstrual pain
timeFrame: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Secondary outcomes:
measure: Menstrual stress level
timeFrame: Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Somatosensory function status
timeFrame: Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Menstrual pain catastrophizing state
timeFrame: Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Menstrual pain beliefs status
timeFrame: Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Anxiety/depressive symptom level
timeFrame: Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Quality of life level
timeFrame: Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
measure: Perception of change
timeFrame: Change in menstrual symptoms immediately after the end of 2 menstrual cycles (each cycle is 28± 7 days) and 3 months after the end of the interventions compared with baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Büşra Nur Erol
Study officials:
affiliation: Hacettepe University
name: Serap Özgül, Prof.
role: PRINCIPAL_INVESTIGATOR
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