Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040866
Status:
RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-09-06
Brief Title:
Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Comparison of the Effects of Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea
Status:
RECRUITING
Status Verified Date:
2023-09
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 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 anxietydepressive symptom level and quality of life in healthy individuals with primary dysmenorrheaThe 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 womens lives significantly It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea
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 womens 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 anxietydepressive 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 anxietydepressive 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 womens lives significantly It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea
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 anxietydepressive 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 womens lives significantly It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea
Study Oversight
Has Oversight DMC:
None
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?:
None