Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05646238
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-11-30
Brief Title:
The Effect of Psychoeducation on Dysmenorrhea in Nursing Students
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
The Effect of Psychoeducation Based on Leventhals Self-Regulation Model on Dysmenorrhea in Nursing Students A Single-Blind Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This study will be conducted to examine the effect of psychoeducation based on Leventhals Self-Regulation Model on dysmenorrhea in nursing students
Detailed Description:
This study will be conducted to examine the effect of psychoeducation based on Leventhals Self-Regulation Model on dysmenorrhea in nursing students
Hypotheses of the Research
H0a There is no difference in menstrual pain severity between the experimental group and the control group receiving psychoeducation based on Leventhals Self-Regulation Model
H0b There is no difference between the Functional and Emotional Dysmenorrhea Scale mean scores between the experimental group and the control group receiving psychoeducation based on Leventhals Self-Regulation Model
H0c There is no difference between the Menstruation Symptom Scale mean scores between the experimental group receiving psychoeducation based on Leventhals Self-Regulation Model and the control group
Menstrual pain severity in women in the experimental and control groups is the primary result of the study
Functional and Emotional Dysmenorrhea Scale and Menstruation Symptom Scale mean scores of the women in the experimental and control groups constitute the secondary results of the study
Type of research The research is a single-center parallel group single-blind randomized controlled experimental study The study will be conducted in accordance with the CONSORT checklist
Participants and setting The population of the research will be female students studying at the Nursing Department of Bitlis Eren University In order to determine the sample size of the study a power analysis GPower 3194 version was conducted by taking the study results of Yılmaz and Şahin 2020 which is similar to our study as reference According to the power analysis the sample size was determined as 62 women in total d075 α 005 1-β90 However by calculating the drop out rate 5 in the study of Yılmaz and Şahin 2020 33 women will be included in each group in our study
Validity-Reliability of the Research Selection bias Inclusion criteria were determined to avoid selection bias All women who met the following criteria were invited to participate in the study
Inclusion criteria
Having a regular menstrual cycle of 6 months
Being Nulliparous
Getting 4 or more points from VAS
Having smart phone and internet facility
Having the technical means to use the ZOOM application
Volunteering to participate in the research Exclusion criteria
Having a diagnosis of any gynecological disease
Having a history of gynecological surgery
Having an active vaginal infection
Not having received psychosocial counseling for dysmenorrhea before
Distribution bias randomization Simple randomization method will be used in the randomization of the research sample Participants who are determined to meet the research criteria will be assigned to the experimental and control groups according to the assignment list created through the computer program
Implementation bias In this study on implementation bias participant blinding will be done For this purpose an active control group will be used in the research However since the implementation of the research will be done by the researchers the researcher cannot be blinded
Detection bias detection bias How the results were collected Measures to prevent detection bias will be made using an online questionnaire
Reporting bias blinding the person who wrote the report and analyzed the data The data obtained from the research aimed at preventing reporting bias will be coded as A and B by an independent statistician and transferred to the SPSS program Analysis of the data will also be done by an independent statistician
Attrition bias reduction bias In case of a decrease in the sample ITT analysis will be performed
Data Collection Inclusion Criteria Form Descriptive Information Form Visual Analog Scale Functional and Emotional Dysmenorrhea Painful Menstruation Scale and Menstruation Symptom Scale will be used to collect data
Introductory Information Form The Introductory Information Form is a 14-question form prepared by the researchers to determine the sociodemographic characteristics age income level family type longest living place and characteristics of menstruation and dysmenorrhea age of menarche duration of pain need for analgesic use analgesics used applications for pain relief of the participants
Visual Analog Scale VAS VAS is a one-dimensional scale that is widely used today to measure subjective parameters such as pain intensity The VAS is a 10 cm long ruler drawn horizontally or vertically starting with No pain and ending with Unbearable pain The patient is instructed to place a mark on this line which corresponds to the severity of the pain to cross this line The numerical index of the patients pain intensity in cm or mm is obtained by measuring the distance from the lowest VAS level to the patients mark with a ruler In the VAS the severity of pain is graded between 0 and 10 points Usually no pain is rated as 0 points and worst pain imaginable is 10 points Ranges for pain intensity 3 mild pain 3-6 moderate pain 6 severe pain
Functional and Emotional Dysmenorrhea Painful Menstruation Scale The Functional and Emotional Dysmenorrhea Scale FEDS is a Likert-type scale used to evaluate dysmenorrhea functionally and emotionally Li et al 2012 Turkish validity and reliability study of the scale was carried out by Gün 2014 The Cronbachs Alpha coefficient of FEDS which consists of 14 items and two sub-dimensions is 091 Each item is scored between 1 one and 5 five There is no reverse item in the scale As the scores obtained from the scale increase the level of functional and emotional impact of dysmenorrhea also increases
Menstruation Symptom Scale MSS It is a scale developed by Chesney and Tasto in 1975 to evaluate menstrual pain and symptoms In 2009 Negriff et al factor structure and usability on adolescents were re-evaluated and updated Guvenc et al Turkish validity and reliability were made in 2014 by Güvenç Seven Akyüz 2014 MSS is a five-point Likert-type scale consisting of twenty-two items Participants are asked to give a number between 1 never and 5 always for the symptoms they experience about menstruation The scale has three sub-dimensions Negative EffectsSomatic Complaints Items 1-13 Menstrual Pain Symptoms Items 14-19 and Coping Methods Items 20-22 The highest score that can be obtained from the scale is 110 and the lowest score is 22 The MSS score is calculated by taking the total mean score of the items in the scale An increase in the mean score indicates an increase in the severity of menstrual symptoms The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases The Cronbachs Alpha value of the original scale is 086
Application of Research There will be two groups in the research namely the experimental and control group The eligibility of the participants to be included in the study will be determined by using the inclusion criteria form Introductory Information Form VAS Functional and Emotional Dysmenorrhea Scale and Menstruation Symptom Scale will be applied to the participants who are determined to be eligible for inclusion in the study After filling out the forms assignments to the groups will be made by randomization
Experimental group-Intervention group Based on Leventhals Self-Regulation Model Students assigned to the experimental group will be divided into groups of 6-9 3 psychoeducation sessions will be held with each group once a week for a total of 3 weeks Group sessions are estimated to last between 60-75 minutes Psychoeducational content based on Leventhals Self-Regulation Model was prepared In the first stage cognitive bases of dysmenorrhea in the second stage strategies to cope with dysmenorrhea and in the third stage the effectiveness of coping strategies in dysmenorrhea will be discussed In the second stage the participants will be taught the progressive muscle relaxation exercise which is among the strategies to cope with dysmenorrhea Sessions will be held online
After the completion of the psychoeducation session measurements will be made in 3 consecutive menstrual cycles starting from the first menstrual cycle Measurements will be made on the first day of each menstrual cycle using the VAS the Functional and Emotional Dysmenorrhea Scale and the Menstruation Symptom Scale
Control Group The control group will be given a online training of 30-45 minutes covering dysmenorrhea and coping in a single session From the first menstrual cycle after the training session is completed measurements will be made in 3 consecutive menstrual cycles Measurements will be made on the first day of each menstrual cycle using the VAS the Functional and Emotional Dysmenorrhea Scale and the Menstruation Symptom Scale
Hypotheses of the Research
H0a There is no difference in menstrual pain severity between the experimental group and the control group receiving psychoeducation based on Leventhals Self-Regulation Model
H0b There is no difference between the Functional and Emotional Dysmenorrhea Scale mean scores between the experimental group and the control group receiving psychoeducation based on Leventhals Self-Regulation Model
H0c There is no difference between the Menstruation Symptom Scale mean scores between the experimental group receiving psychoeducation based on Leventhals Self-Regulation Model and the control group
Menstrual pain severity in women in the experimental and control groups is the primary result of the study
Functional and Emotional Dysmenorrhea Scale and Menstruation Symptom Scale mean scores of the women in the experimental and control groups constitute the secondary results of the study
Type of research The research is a single-center parallel group single-blind randomized controlled experimental study The study will be conducted in accordance with the CONSORT checklist
Participants and setting The population of the research will be female students studying at the Nursing Department of Bitlis Eren University In order to determine the sample size of the study a power analysis GPower 3194 version was conducted by taking the study results of Yılmaz and Şahin 2020 which is similar to our study as reference According to the power analysis the sample size was determined as 62 women in total d075 α 005 1-β90 However by calculating the drop out rate 5 in the study of Yılmaz and Şahin 2020 33 women will be included in each group in our study
Validity-Reliability of the Research Selection bias Inclusion criteria were determined to avoid selection bias All women who met the following criteria were invited to participate in the study
Inclusion criteria
Having a regular menstrual cycle of 6 months
Being Nulliparous
Getting 4 or more points from VAS
Having smart phone and internet facility
Having the technical means to use the ZOOM application
Volunteering to participate in the research Exclusion criteria
Having a diagnosis of any gynecological disease
Having a history of gynecological surgery
Having an active vaginal infection
Not having received psychosocial counseling for dysmenorrhea before
Distribution bias randomization Simple randomization method will be used in the randomization of the research sample Participants who are determined to meet the research criteria will be assigned to the experimental and control groups according to the assignment list created through the computer program
Implementation bias In this study on implementation bias participant blinding will be done For this purpose an active control group will be used in the research However since the implementation of the research will be done by the researchers the researcher cannot be blinded
Detection bias detection bias How the results were collected Measures to prevent detection bias will be made using an online questionnaire
Reporting bias blinding the person who wrote the report and analyzed the data The data obtained from the research aimed at preventing reporting bias will be coded as A and B by an independent statistician and transferred to the SPSS program Analysis of the data will also be done by an independent statistician
Attrition bias reduction bias In case of a decrease in the sample ITT analysis will be performed
Data Collection Inclusion Criteria Form Descriptive Information Form Visual Analog Scale Functional and Emotional Dysmenorrhea Painful Menstruation Scale and Menstruation Symptom Scale will be used to collect data
Introductory Information Form The Introductory Information Form is a 14-question form prepared by the researchers to determine the sociodemographic characteristics age income level family type longest living place and characteristics of menstruation and dysmenorrhea age of menarche duration of pain need for analgesic use analgesics used applications for pain relief of the participants
Visual Analog Scale VAS VAS is a one-dimensional scale that is widely used today to measure subjective parameters such as pain intensity The VAS is a 10 cm long ruler drawn horizontally or vertically starting with No pain and ending with Unbearable pain The patient is instructed to place a mark on this line which corresponds to the severity of the pain to cross this line The numerical index of the patients pain intensity in cm or mm is obtained by measuring the distance from the lowest VAS level to the patients mark with a ruler In the VAS the severity of pain is graded between 0 and 10 points Usually no pain is rated as 0 points and worst pain imaginable is 10 points Ranges for pain intensity 3 mild pain 3-6 moderate pain 6 severe pain
Functional and Emotional Dysmenorrhea Painful Menstruation Scale The Functional and Emotional Dysmenorrhea Scale FEDS is a Likert-type scale used to evaluate dysmenorrhea functionally and emotionally Li et al 2012 Turkish validity and reliability study of the scale was carried out by Gün 2014 The Cronbachs Alpha coefficient of FEDS which consists of 14 items and two sub-dimensions is 091 Each item is scored between 1 one and 5 five There is no reverse item in the scale As the scores obtained from the scale increase the level of functional and emotional impact of dysmenorrhea also increases
Menstruation Symptom Scale MSS It is a scale developed by Chesney and Tasto in 1975 to evaluate menstrual pain and symptoms In 2009 Negriff et al factor structure and usability on adolescents were re-evaluated and updated Guvenc et al Turkish validity and reliability were made in 2014 by Güvenç Seven Akyüz 2014 MSS is a five-point Likert-type scale consisting of twenty-two items Participants are asked to give a number between 1 never and 5 always for the symptoms they experience about menstruation The scale has three sub-dimensions Negative EffectsSomatic Complaints Items 1-13 Menstrual Pain Symptoms Items 14-19 and Coping Methods Items 20-22 The highest score that can be obtained from the scale is 110 and the lowest score is 22 The MSS score is calculated by taking the total mean score of the items in the scale An increase in the mean score indicates an increase in the severity of menstrual symptoms The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases The Cronbachs Alpha value of the original scale is 086
Application of Research There will be two groups in the research namely the experimental and control group The eligibility of the participants to be included in the study will be determined by using the inclusion criteria form Introductory Information Form VAS Functional and Emotional Dysmenorrhea Scale and Menstruation Symptom Scale will be applied to the participants who are determined to be eligible for inclusion in the study After filling out the forms assignments to the groups will be made by randomization
Experimental group-Intervention group Based on Leventhals Self-Regulation Model Students assigned to the experimental group will be divided into groups of 6-9 3 psychoeducation sessions will be held with each group once a week for a total of 3 weeks Group sessions are estimated to last between 60-75 minutes Psychoeducational content based on Leventhals Self-Regulation Model was prepared In the first stage cognitive bases of dysmenorrhea in the second stage strategies to cope with dysmenorrhea and in the third stage the effectiveness of coping strategies in dysmenorrhea will be discussed In the second stage the participants will be taught the progressive muscle relaxation exercise which is among the strategies to cope with dysmenorrhea Sessions will be held online
After the completion of the psychoeducation session measurements will be made in 3 consecutive menstrual cycles starting from the first menstrual cycle Measurements will be made on the first day of each menstrual cycle using the VAS the Functional and Emotional Dysmenorrhea Scale and the Menstruation Symptom Scale
Control Group The control group will be given a online training of 30-45 minutes covering dysmenorrhea and coping in a single session From the first menstrual cycle after the training session is completed measurements will be made in 3 consecutive menstrual cycles Measurements will be made on the first day of each menstrual cycle using the VAS the Functional and Emotional Dysmenorrhea Scale and the Menstruation Symptom Scale
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