Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain
1 other identifier
interventional
74
1 country
1
Brief Summary
Menstruation is the bleeding that starts with menarche and continues until menopause, along with hormonal changes in women of reproductive age, and is shed as the endometrium matures and is shed. Menstruation, which covers 30-35 years of a woman's life and occurs regularly every month, is a physiological process. Menstrual cycle problems are a condition that affects health and society all over the world and causes treatment to be sought. It is one of the most common menstrual cycle problems. Dysmenorrhea is used synonymously with menstrual pain in clinics and practice. It is stated that approximately 40-50% of women experience dysmenorrhea and that it is more common in adolescents. Dysmenorrhea is a symptom that causes changes in women's physical activities and social roles, leading to a decrease in their quality of life. Dysmenorrhea usually manifests itself with symptoms such as pain and cramps in the back and lower abdomen, as well as nausea, vomiting, fatigue, irritability, appetite changes, diarrhea, and headache. According to the literature, among the choices of women to cope with dysmenorrhea, manipulative and body-based practices (massage, relaxation exercises, acupuncture, aromatherapy, hot-cold applications, etc.), mind-body-based practices (meditation, yoga, hypnotherapy, hypnosis, music therapy, etc.), vitamin-mineral supplements and herbal therapies (vitamins B and E, magnesium, zinc, fennel/rose tea, black cohosh, etc.) and exercise programs are seen to be effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFebruary 17, 2025
February 1, 2025
4 months
December 9, 2024
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scale for Assessing the Impact of Dysmenorrhea on Daily Life (SAIDDL)
The Scale for Assessing the Impact of Dysmenorrhea on Daily Life was prepared to determine and compare the extent to which daily life is affected by the pain experienced during menstruation. On the 3rd day of each menstrual period, the degree to which daily life is affected is marked on the horizontal line with the numerical values between 0 and 10. A score of 0 on the scale indicates that daily life is "not affected at all" by dysmenorrhea, while a score of 10 indicates that it is "completely affected".
4 weeks
Secondary Outcomes (2)
Pain Beliefs Scale (BPS)
4 weeks
McGill Pain Scale Short Form (MSS-SF)
4 weeks
Study Arms (2)
Pain neuroscience education group (PNE)
EXPERIMENTALThe cases in this group will be given online PNE training one week before menstruation.
Control Group (CG)
OTHERNo training or application will be given to the control group
Interventions
PNE was planned online for clients 1 week before menstruation in the form of speaking sessions in a presentation format. The training will be conveyed in relation to pain during menstruation. Visual aids, examples and metaphors will be used to improve patient understanding in the training. Ankle sprain picture, speeding bus picture, action potential picture, picture showing membrane resting potential, rusty nail picture, whole body nervous system picture, neuromatrix picture, lion and lion cub picture that helps explain stress responses, curious neighbors picture etc. will be used. The training session is planned to last between 2 and 4 hours. The distribution of pain neuroscience training topics will be implemented in the order given below, with 10 main headings. * Pain and the Biopsychosocial Model * Injury and pain are not equivalent, pain is a brain output rather than an input * Action potential, normal electrical activity of nerves and conduction * Biological process of ion chann
The control group will not receive any training or practice.
Eligibility Criteria
You may qualify if:
- Being over 18 years of age,
- Not having a previous pregnancy,
- Not having a history of pelvic infections
- Not using hormonal contraception and intrauterine devices,
- Having a menstrual period of 3-8 days and a menstrual cycle interval of 21-35 days,
- Being willing to participate in the study.
You may not qualify if:
- Being under 18 years of age,
- Having a previous pregnancy,
- Having a history of pelvic infections
- Using hormonal contraception and intrauterine devices,
- Not having a menstrual period of 3-8 days and a menstrual cycle interval of 21-35 days,
- Not being willing to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uskudar University, Faculty of Health Sciences
Istanbul, 34000, Turkey (Türkiye)
Related Publications (4)
Zimney K, Van Bogaert W, Louw A. The Biology of Chronic Pain and Its Implications for Pain Neuroscience Education: State of the Art. J Clin Med. 2023 Jun 21;12(13):4199. doi: 10.3390/jcm12134199.
PMID: 37445234RESULTO'Connor M, Sillevis R, Erickson MR. Pain Neuroscience Education Delivered by a Student Physical Therapist for a Patient with Persistent Musculoskeletal Pain. Am J Case Rep. 2021 Aug 16;22:e932212. doi: 10.12659/AJCR.932212.
PMID: 34398869RESULTLouw A, Farrell K, Choffin B, Foster B, Lunde G, Snodgrass M, Sweet R, Weitzel M, Wilder R, Puentedura EJ. Immediate effect of pain neuroscience education for recent onset low back pain: an exploratory single arm trial. J Man Manip Ther. 2019 Dec;27(5):267-276. doi: 10.1080/10669817.2019.1624006. Epub 2019 Jun 4.
PMID: 31161919RESULTSillevis R, Trincado G, Shamus E. The immediate effect of a single session of pain neuroscience education on pain and the autonomic nervous system in subjects with persistent pain, a pilot study. PeerJ. 2021 May 31;9:e11543. doi: 10.7717/peerj.11543. eCollection 2021.
PMID: 34131526RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
osman coban, Asst Prof.
Uskudar University
- PRINCIPAL INVESTIGATOR
cigdem inkaya, PT
Uskudar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Professor
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 13, 2024
Study Start
October 1, 2024
Primary Completion
January 31, 2025
Study Completion
February 1, 2025
Last Updated
February 17, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share