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Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Pain neuroscience education
Biomedical pain education
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Not having any known disease (systemic, metabolic, etc.), Meeting the primary dysmenorrhea criteria specified in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe menstrual pain felt on the 1st or 2nd day of menstruation), Having a regular menstrual cycle (28± 7 days), In the last 6 months, menstrual pain intensity is ≥ 4 cm according to the visual analog scale, Nulligravid, 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 Using anti-depressants or anxiolytics because of their ability to modulate the sensation of pain, Receiving alternative treatment, Individuals using an intrauterine contraceptive device or birth control pill will not be included.

Sites / Locations

  • Büşra Nur ErolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain neuroscience education

Biomedical pain education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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".
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.
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.
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.

Full Information

First Posted
September 6, 2023
Last Updated
September 14, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT06040866
Brief Title
Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
Official Title
Comparison of the Effects of Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 calculated by assuming a standard deviation of 1 with a minimum study power of 80% and predicting an equal distribution to the study arms; 19 individuals for the first research arm and 19 individuals for the second research arm, a total of 38 individuals were determined. The research will be terminated after all evaluations of all individuals participating in the study are completed, when the targeted sample size and power are reached. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain neuroscience education
Arm Type
Experimental
Arm Description
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.
Arm Title
Biomedical pain education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Biomedical pain education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of menstrual pain
Description
Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing
Time Frame
Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Secondary Outcome Measure Information:
Title
Menstrual stress level
Description
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.
Time Frame
Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Somatosensory function status
Description
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.
Time Frame
Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Menstrual pain catastrophizing state
Description
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.
Time Frame
Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Menstrual pain beliefs status
Description
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".
Time Frame
Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Anxiety/depressive symptom level
Description
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.
Time Frame
Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Quality of life level
Description
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.
Time Frame
Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Title
Perception of change
Description
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.
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Not having any known disease (systemic, metabolic, etc.), Meeting the primary dysmenorrhea criteria specified in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe menstrual pain felt on the 1st or 2nd day of menstruation), Having a regular menstrual cycle (28± 7 days), In the last 6 months, menstrual pain intensity is ≥ 4 cm according to the visual analog scale, Nulligravid, 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 Using anti-depressants or anxiolytics because of their ability to modulate the sensation of pain, Receiving alternative treatment, Individuals using an intrauterine contraceptive device or birth control pill will not be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serap Özgül, Prof.
Phone
+905339390803
Email
serapky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap Özgül, Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Büşra Nur Erol
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Büşra Nur Erol, PhD student
Phone
+905444932720
Email
icerbusra@gmail.com
First Name & Middle Initial & Last Name & Degree
Ceren Gürşen, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Sezcan Mümüşoğlu, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
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Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

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