Primary DysmenorrheaNCT06040866
Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
A study testing Exercise training, Pain neuroscience education and Biomedical pain education in people with Primary Dysmenorrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Exercise training, Pain neuroscience education and Biomedical pain education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2023to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pain Neuroscience Education or Biomedical Pain Education With Exercise Training in Primary Dysmenorrhea: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Exercise training, Pain neuroscience education, Biomedical pain education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Exercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week.
Pain neuroscience educationOther
Participants in the first research 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.
Biomedical pain educationOther
Participants in the second research 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.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education | Experimental | 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. Receives: Other: Exercise training; Other: Pain neuroscience education |
| Biomedical pain education | Active comparator | 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. Receives: Other: Exercise training; Other: Biomedical pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of menstrual pain
Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing
Measured: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Secondary outcomes (7)
Menstrual stress level
Menstrual Distress Questionnaire (MDQ): The scale consists of 47 menstrual symptoms and 8 sub-symptom groups. Complaints are scored from 0 to 4. 0=no symptoms, 1=little, 2=moderate, 3=severe, 4=very severe.
Measured: Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Somatosensory function status
Central Sensitization Inventory (CSI): CSI consists of two parts. Part A contains 25 items that assess somatic and emotional health-related symptoms common in Central sensitization-related disorders.
Each item is graded on a 5-point scale from (0) "never" to (4) "always", with a maximum total score of 100. Higher scores indicate a higher degree of symptomatology. Section B includes 7 diagnoses of central sensitization syndromes (tension headaches/migraine, fibromyalgia, irritable bowel syndrome, restless legs syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three additional diagnoses found to be associated with central sensitization ( depression, anxiety/panic attack, and neck injury); Participants were asked, together with the year of diagnosis, "Has any of the following conditions been diagnosed by a doctor?" contains the question.
Measured: Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain catastrophizing state
Pain Catastrophizing Scale: It has 13 items and consists of 3 sub-dimensions (helplessness, magnification and rumination). Questions are scored between 0-4. Subscales are determined by summing the scores of each item, and the total score (between 0 and 52 points) is calculated with the sum of all items. A higher score means a greater degree of catastrophization.
Measured: Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain beliefs status
Pain Beliefs Questionnaire (PBQ): It contains 12 items related to pain beliefs. PBQ-O is an 8-item subscale, and PBQ-P is a 4-item subscale. Organic beliefs sub-dimension consists of items 1, 2, 3, 5, 7, 8, 10 and 11, and psychological beliefs sub-dimension consists of items 4, 6, 9 and 12. Participants mark the appropriate answer for themselves on a 6-point response scale ranging from "always" to "never".
Measured: Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Anxiety/depressive symptom level
Depression Anxiety Stress Scales-21 (DASS-21): It is a valid measure for depression, anxiety, and stress in adults. Each of the three subscales contains 7 items; each is answered from zero (never) to three (always).
Higher scores indicate greater levels of depression, anxiety, and stress.
Measured: Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Quality of life level
World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF): 442 / 5.000 Çeviri sonuçları The WHOQOl-BREF is a 26-item self-administered questionnaire and covers 4 dimensions of quality of life (6 items for psychological health, 7 items for physical health, 3 items for social relationships, and 8 items for environmental health). Except for 3 questions targeting pain and discomfort, need for medical treatment, and negative emotions, each question has response categories ranging from 1 to 5, and a high score indicates high quality of life.
Measured: Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Perception of change
5-point likert scale: Individuals' perception of subjective changes in menstrual pain and other menstrual symptoms with interventions will be evaluated. -2= much worse, -1= slightly worse, 0= no change, 1= slightly better, 2= much better. The changes in the menstrual symptoms of the individuals just after the end of the interventions and 3 months after the end of the interventions will be questioned when compared with the baseline.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start9 Oct 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
- Investigators
- Serap Özgül, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040866
- Sponsor's protocol ID
- KA-22038
- Status last verified
- Jan 2025
- First submitted
- 6 Sep 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponce-Fuentes F, Cuyul-Vasquez I, Bustos-Medina L, Fuentes J. Effects of pain neuroscience education and rehabilitation following arthroscopic rotator cuff repair. A randomized clinical trial. Physiother Theory Pract. 2023 Sep 2;39(9):1861-1870. doi: 10.1080/09593985.2022.2061394. Epub 2022 Apr 12.
PubMed 35412432Li X, Hao X, Liu JH, Huang JP. Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis. BMJ Evid Based Med. 2024 May 22;29(3):162-170. doi: 10.1136/bmjebm-2023-112434.
PubMed 38242565Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.
PubMed 29630882Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
PubMed 28844356Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.
PubMed 5749738Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
PubMed 21951710Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.
PubMed 1491853The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
PubMed 9672396Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
PubMed 2691207Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
PubMed 25558568Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
PubMed 35382371Haldeman S. North American Spine Society: failure of the pathology model to predict back pain. Spine (Phila Pa 1976). 1990 Jul;15(7):718-24. No abstract available.
PubMed 2145646Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.
PubMed 21632273
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education or Biomedical Pain Education With Exercise Training in Primary Dysmenorrhea: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06040866
- Acronym / sponsor ID
- KA-22038
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education | Experimental | Other: Exercise training, Other: Pain neuroscience educationIn 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. |
| Biomedical pain education | Active comparator | Other: Exercise training, Other: Biomedical pain educationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week. | Other | Biomedical pain education, Pain neuroscience education |
| Pain neuroscience educationParticipants in the first research 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. | Other | Pain neuroscience education |
| Biomedical pain educationParticipants in the second research 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. | Other | Biomedical pain education |
Primary outcome
Severity of menstrual pain
Time frame: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing
7 secondary outcomes
Menstrual stress level
Time frame: Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Somatosensory function status
Time frame: Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain catastrophizing state
Time frame: Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain beliefs status
Time frame: Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Anxiety/depressive symptom level
Time frame: Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Quality of life level
Time frame: Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Perception of change
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 35412432Ponce-Fuentes F, Cuyul-Vasquez I, Bustos-Medina L, Fuentes J. Effects of pain neuroscience education and rehabilitation following arthroscopic rotator cuff repair. A randomized clinical trial. Physiother Theory Pract. 2023 Sep 2;39(9):1861-1870. doi: 10.1080/09593985.2022.2061394. Epub 2022 Apr 12.
- Background: PubMed 38242565Li X, Hao X, Liu JH, Huang JP. Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis. BMJ Evid Based Med. 2024 May 22;29(3):162-170. doi: 10.1136/bmjebm-2023-112434.
- Background: PubMed 29630882Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.
- Background: PubMed 28844356Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
- Background: PubMed 5749738Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.
- Background: PubMed 21951710Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 1491853Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.
- Background: PubMed 9672396The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
- Background: PubMed 2691207Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
- Background: PubMed 25558568Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
- Background: PubMed 35382371Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Özgül, Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training, Pain neuroscience education and Biomedical pain education in people with Primary Dysmenorrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of menstrual pain (time frame: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040866, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.