NCT06732778

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

December 9, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

dysmenorrheapainquality of lifepain neuroscience education

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)

EXPERIMENTAL

The cases in this group will be given online PNE training one week before menstruation.

Other: Pain Neuroscience Education (PNE)

Control Group (CG)

OTHER

No training or application will be given to the control group

Other: Control Group (CG)

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

Pain neuroscience education group (PNE)

The control group will not receive any training or practice.

Control Group (CG)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenstruation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

  • O'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.

  • Louw 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.

  • Sillevis 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.

MeSH Terms

Conditions

AgnosiaDysmenorrheaPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic ProcessesPelvic Pain

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • osman coban, Asst Prof.

    Uskudar University

    STUDY DIRECTOR
  • cigdem inkaya, PT

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled Trial
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

Locations