Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT07196150
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise, Motor Imagery, and Pain Neuroscience Education for Primary Dysmenorrhea: A Randomized Trial
Sponsor:
Muge Dereli
Organization:
Study Overview
Official Title:
Comparison of the Effects of Exercise, Motor Imagery Training, and Pain Neuroscience Education on Pain, Menstrual Symptoms, and Cognitive Flexibility in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to find out whether exercise, motor imagery training, and pain neuroscience education can help reduce menstrual pain and improve well-being in young women with primary dysmenorrhea. The study will also look at how these approaches affect menstrual symptoms, movement control, and cognitive flexibility.
The main questions it aims to answer are:
* Does adding motor imagery or pain neuroscience education to an exercise program reduce pain and menstrual symptoms more than exercise alone?
* Do these approaches improve movement control, thinking flexibility, and knowledge about pain?
Researchers will compare three groups:
* Exercise only
* Exercise plus motor imagery training
* Exercise plus pain neuroscience education
Participants will:
* Attend supervised exercise sessions twice a week for 8 weeks
* Practice either motor imagery or receive short pain neuroscience education, depending on their group
* Complete questionnaires and tests before and after the program, during the first three days of menstruation
The main questions it aims to answer are:
* Does adding motor imagery or pain neuroscience education to an exercise program reduce pain and menstrual symptoms more than exercise alone?
* Do these approaches improve movement control, thinking flexibility, and knowledge about pain?
Researchers will compare three groups:
* Exercise only
* Exercise plus motor imagery training
* Exercise plus pain neuroscience education
Participants will:
* Attend supervised exercise sessions twice a week for 8 weeks
* Practice either motor imagery or receive short pain neuroscience education, depending on their group
* Complete questionnaires and tests before and after the program, during the first three days of menstruation
Detailed Description:
Primary dysmenorrhea is a common gynecological condition characterized by menstrual pain without underlying pathology. It negatively impacts quality of life and may affect cognitive functions such as attention and flexibility. Non-pharmacological interventions such as exercise, motor imagery, and pain neuroscience education are promising approaches for pain management without side effects. However, evidence on their effectiveness in primary dysmenorrhea is limited.
This randomized controlled trial is designed to compare the effects of three different interventions in young women with primary dysmenorrhea:
* Exercise only (control group)
* Exercise plus Motor Imagery Training
* Exercise plus Pain Neuroscience Education (PNE)
Eligible participants will be women aged 18-25 years who meet the diagnostic criteria for primary dysmenorrhea based on gynecological examination and ultrasound findings. Participants will be randomly assigned into one of the three groups. All groups will undergo an 8-week supervised exercise program (two sessions per week) focusing on lumbopelvic stabilization, flexibility, and endurance training. In addition:
* The Motor Imagery group will practice kinesthetic visualization of the exercises prior to performing them.
* The PNE group will receive weekly face-to-face education sessions on pain mechanisms, supported with home assignments.
Primary outcome measures are:
* Pain intensity (Numeric Pain Rating Scale)
* Pressure pain threshold (Baseline dolorimeter)
* Menstrual symptoms (Menstrual Symptom Questionnaire).
Secondary outcome measures are:
* Lumbopelvic motor control (Physiosupplies Core Stabilizer Unit)
* Movement Imagery Questionnaire
* Central Sensitization Inventory
* Cognitive flexibility (Stroop Test)
* Pain Catastrophizing Scale
* Pain Resilience Scale
* Modified Pain Neurophysiology Questionnaire.
Assessments will be conducted at baseline and after the 8-week intervention, within the first three days of menstruation. Additional follow-up data will be collected through online forms one month after the intervention to evaluate persistence of effects.
The estimated sample size of 51 was calculated considering a 10% attrition rate. Statistical analyses will be performed using SPSS software. Depending on data distribution, repeated measures ANOVA or non-parametric equivalents will be used to compare changes over time and between groups.
This study is expected to provide new evidence regarding the effectiveness of combining exercise with motor imagery or pain neuroscience education for the management of pain, menstrual symptoms, and cognitive flexibility in women with primary dysmenorrhea. The findings may contribute to the development of safe and effective non-pharmacological strategies in women's health and pain management.
This randomized controlled trial is designed to compare the effects of three different interventions in young women with primary dysmenorrhea:
* Exercise only (control group)
* Exercise plus Motor Imagery Training
* Exercise plus Pain Neuroscience Education (PNE)
Eligible participants will be women aged 18-25 years who meet the diagnostic criteria for primary dysmenorrhea based on gynecological examination and ultrasound findings. Participants will be randomly assigned into one of the three groups. All groups will undergo an 8-week supervised exercise program (two sessions per week) focusing on lumbopelvic stabilization, flexibility, and endurance training. In addition:
* The Motor Imagery group will practice kinesthetic visualization of the exercises prior to performing them.
* The PNE group will receive weekly face-to-face education sessions on pain mechanisms, supported with home assignments.
Primary outcome measures are:
* Pain intensity (Numeric Pain Rating Scale)
* Pressure pain threshold (Baseline dolorimeter)
* Menstrual symptoms (Menstrual Symptom Questionnaire).
Secondary outcome measures are:
* Lumbopelvic motor control (Physiosupplies Core Stabilizer Unit)
* Movement Imagery Questionnaire
* Central Sensitization Inventory
* Cognitive flexibility (Stroop Test)
* Pain Catastrophizing Scale
* Pain Resilience Scale
* Modified Pain Neurophysiology Questionnaire.
Assessments will be conducted at baseline and after the 8-week intervention, within the first three days of menstruation. Additional follow-up data will be collected through online forms one month after the intervention to evaluate persistence of effects.
The estimated sample size of 51 was calculated considering a 10% attrition rate. Statistical analyses will be performed using SPSS software. Depending on data distribution, repeated measures ANOVA or non-parametric equivalents will be used to compare changes over time and between groups.
This study is expected to provide new evidence regarding the effectiveness of combining exercise with motor imagery or pain neuroscience education for the management of pain, menstrual symptoms, and cognitive flexibility in women with primary dysmenorrhea. The findings may contribute to the development of safe and effective non-pharmacological strategies in women's health and pain management.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB# 0260 | OTHER | İzmir Katip Çelebi University Health Research Ethics Committee | View |