Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202352
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-11
First Post:
2023-12-31
Brief Title:
Basic Yoga and Meditation Techniques
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Basic Yoga and Meditation Techniques on Midwifery Students Anxiety and Perceived Stress Levels
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
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:
Purpose of the research To determine the effect of basic yoga techniques and meditation intervention on midwifery students anxiety and perceived stress levels
Yoga is alternative mind-body exercises that aim to establish a connection between the brain and body Derived from the Sankiritic term yuj yoga means to integrate Yoga techniques focus on self-awareness and require careful coordination of body movementspostures asanas deep breathing pranayama and meditation Yoga can be used as a complementary and alternative method for various diseases or improving well-being Yoga is becoming increasingly important in improving mental health In this planned study we aim to manage the anxiety and perceived stress that students studying in the field of health mostly suffer from with yoga techniques
After the sociodemographic data of the volunteer participants who agree to take part in the research are identified and recorded in the first stage the screening phase according to the power analysis the minimum number of participants determined will be assigned to the experimental and control groups by randomization In the second stage of the research the experimental group Yoga techniques and meditation practices once a week for 8 weeks will be performed at times when anxiety and stress are most intense before exams laboratory and hospital applications Students in the control group will continue their routine coping habits with anxiety and stress Students will complete pre- and post-intervention surveys to assess changes in anxiety and perceived stress The anxiety and stress levels of students in both groups will be determined by applying the Beck Anxiety Inventory and the Perceived Stress Scale before and after the intervention The data obtained after the interventions will be compared with appropriate statistical analysis and converted into a report
The proposed research aims to provide scientific research skills and experience to the 2nd year students of Atatürk University Faculty of Health Sciences Department of Midwifery who are involved in the project In addition it is expected that the proposed project will show how it affects the anxiety and perceived stress levels of midwifery students in the international media and literature and emphasize its positive effects on the management of the well-being of these individuals
Yoga is alternative mind-body exercises that aim to establish a connection between the brain and body Derived from the Sankiritic term yuj yoga means to integrate Yoga techniques focus on self-awareness and require careful coordination of body movementspostures asanas deep breathing pranayama and meditation Yoga can be used as a complementary and alternative method for various diseases or improving well-being Yoga is becoming increasingly important in improving mental health In this planned study we aim to manage the anxiety and perceived stress that students studying in the field of health mostly suffer from with yoga techniques
After the sociodemographic data of the volunteer participants who agree to take part in the research are identified and recorded in the first stage the screening phase according to the power analysis the minimum number of participants determined will be assigned to the experimental and control groups by randomization In the second stage of the research the experimental group Yoga techniques and meditation practices once a week for 8 weeks will be performed at times when anxiety and stress are most intense before exams laboratory and hospital applications Students in the control group will continue their routine coping habits with anxiety and stress Students will complete pre- and post-intervention surveys to assess changes in anxiety and perceived stress The anxiety and stress levels of students in both groups will be determined by applying the Beck Anxiety Inventory and the Perceived Stress Scale before and after the intervention The data obtained after the interventions will be compared with appropriate statistical analysis and converted into a report
The proposed research aims to provide scientific research skills and experience to the 2nd year students of Atatürk University Faculty of Health Sciences Department of Midwifery who are involved in the project In addition it is expected that the proposed project will show how it affects the anxiety and perceived stress levels of midwifery students in the international media and literature and emphasize its positive effects on the management of the well-being of these individuals
Detailed Description:
Introduction Derived from the Sanskrit word yuj yoga means integrated awareness of mind and body Yoga techniques are popular practices that include the coordination of different posture techniques deep breathing practices and meditation Sarbacker and Kimple 2015 Since yoga is a mental exercise that slows down brain waves it can help eliminate negative emotions and ensure awareness and cognitive balance Desai et al 2015 It has been understood that controlling perceived stress not only reduces mood disorders but also provides better sensorimotor performance and hand grip endurance Bajunaid et al 2015 Midwifery is a discipline in which theory and practice are carried out in an integrated manner and it requires the completion of difficult complex graduation criteria regarding the prenatal intraparum and postpartum processes Aydın Kartal and Yazıcı 2017 Nehir and Güngör Tavşanlı 2021 In general in studies conducted on midwifery students it is observed that stress and anxiety are inevitably high Aydın Kartal and Yazıcı 2017 Nehir and Güngör Tavşanlı 2021 Since todays midwifery students will be the expert midwives of the future the physical and mental health of midwifery students can increase the welfare of society In this context teaching midwifery students to connect with their body and mind may increase psychological well-being
According to the results of a limited number of studies yoga exercises provided positive effects on medicalhealth education students suffering from intense stress and anxiety Erogul et al 2014 Fares and Fares 2016 The limited number of studies conducted in the field of health education on the effects of yoga and meditation focused on students of medicine pharmacy and nursing departments Lemay et al 2019 Ciezar-Andersen et al 2021 On the other hand despite the popularity of yoga in studies mostly in western societies Shohani et al 2018 to our knowledge how it prevents mood disorders in the field of midwifery has not been studied Studies on the effects of yoga are limited in Turkey
Method The total screening of the project will be carried out in 2 stages In the first stage students anxiety and stress levels will be screened After the screening study students demographic characteristics general anxiety and perceived stress levels will be measured According to the data obtained from the scanning study the numbered forms will be put in order and the data obtained will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program According to the data obtained as a result of the screening study participants 72 students who will be sampled according to their anxiety and perceived stress levels will be assigned to the yoga techniques and control group A randomization program wwwrandomizeorg will be used to assign groups
Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in Appointments will be made with students assigned to study groups and yogameditation techniques will begin in a suitable room at the faculty Meetings will be arranged with the yoga and control groups determined during the selection phase after the lesson hours of each class Two separate WhatsApp groups will be created control and yoga groups The responsible researcher has an international yoga training certificate
Yoga and meditation practices 8 weeks once a week 60 minutes
The yoga and meditation intervention will use a 60-minute vinyasa yoga class once a week followed by a guided yoga instruction booklet that takes an average of 30 minutes to read The intervention will be carried out in the last eight weeks of the spring semester when hospital practices are most intense and before the final exams Posttest forms will be filled out the week of final exams The time devoted to meditation will be increased every week for the last two weeks starting with 5 minutes and gradually increasing to 20 minutes in the eighth week
Application Places of the Research It will be carried out in a suitable room at Atatürk University Faculty of Health Sciences Department of Midwifery
Details of Study Design and Method
The planned study is a pre-posttest-posttest randomized controlled experimental study
Sample Size Population and Sample of the Research The population of the study will consist of 724 registered students studying at Atatürk University Faculty of Health Sciences Department of Midwifery 1st 2nd 3rd 4th Grade in the 2023-2024 academic year The maximum number of students sample to be included in the study was calculated using GPower 3197 software Taking Shohani et als 2018 study titled The Effect of Yoga on Stress Anxiety and Depression in Women as a reference it was determined that the effect size of the difference between pre- and post-training individuals in the experimental group who received yoga training was 0351 Accordingly the sample size required for 80 1-β080 power at d 0 351 and α 005 was calculated as 33 people from each group Considering the possibility of midwifery students leaving the groups during the research it was decided that the number of samples in the groups would be 36 based on a 10 loss Students who do not meet the inclusion criteria for the study will not be included in the randomization
Since it is aimed to reach all midwifery students in the survey study no sample selection will be made In order to reach eligible students later after the screening students contact information will be written in the surveys and the scales will be numbered At this stage 72 students who meet the inclusion criteria for this study and volunteer will be divided into control and yoga groups The dependent variables of the study are yoga and meditation Independent variables are anxiety level and perceived stress level Additionally students will have to sign an Informed Consent Form
Collecting Study Data and Recording Data Data Collection Tools Sociodemographic data of midwifery students will be recorded with the Student Identification and Monitoring Form prepared by the research team In addition the Beck Anxiety Scale and Perceived Stress Scale will be used for the screening study before and after the intervention
Student Diagnosis and Monitoring Form ANNEX-1 Student Identification and Follow-up Form to be used in collecting research data A form will be used to inquire about the situations related to name surname class age height weight age marital status place of residence mother and fathers working status and attitude towards exercise This information will be filled in by self-report method
Beck Anxiety Scale BAI ANNEX-2 The scale evaluates the severity of generalized anxiety symptoms This instrument focuses on somatic symptoms of anxiety and contains 21 items Responses are based on a 4-point Likert scale ranging from 0 not at all to 3 severely with a maximum total score of 63 Scores between 0 and 21 indicate low anxiety scores between 22 and 35 indicate moderate anxiety and scores of 36 and above indicate high anxiety The scale was adapted to the Turkish sample by Durak and Palabıyıkoğlu Durak and Palabıyıkoğlu 1994
Perceived Stress Scale PSS Annex-3 It was adapted into Turkish by Eskin et al 2013 Measuring stress is important for scientific research and application activities to be carried out in our country ASÖ reliability coefficient was calculated as 087 Eskin et al 2013 The scale in question consists of 14 items Erci 2006 The scale has two subscales Perception of Insufficient Self-Efficacy and Perception of StressDiscomfort Items 1 2 3 7 11 12 and 14 constitute the Perception of StressDiscomfort dimension and items 4 5 6 8 9 10 and 13 constitute the Perception of Insufficient Self-Efficacy dimension In the scale items 4 5 6 7 9 10 and 13 are scored reversely The total score determined as a result of the scale application indicates the stress level It shows low stress level between 11-26 points medium stress level between 27-41 points and high stress level between 42-56 points
Application of Research The total screening of the project will be carried out in 2 stages In the first stage students anxiety and stress levels will be screened After the screening study students demographic characteristics general anxiety and perceived stress levels will be measured According to the data obtained from the scanning study the numbered forms will be put in order and the data obtained will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program According to the data obtained as a result of the screening study participants 72 students who will be sampled according to their anxiety and perceived stress levels will be assigned to the yoga techniques and control group A randomization program wwwrandomizeorg will be used to assign groups
Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in Appointments will be made with students assigned to study groups and yogameditation techniques will begin in a suitable room at the faculty Meetings will be arranged with the yoga and control groups determined during the selection phase after the lesson hours of each class Two separate WhatsApp groups will be created control and yoga groups The responsible researcher has an international yoga training certificate
Description of Transactions on Working Days Visits if any Students currently studying at Atatürk University Faculty of Health Sciences Department of Midwifery will be informed about the research and invited to participate in the research Research data will be collected from students who agree to participate in the research using a survey form and face-to-face interview technique
Randomization Method Importance if any Randomization will be provided in an online program A randomization program wwwrandomizeorg will be used to assign groups Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in
Ensuring Patient Compliance if any Before starting the research approval will be obtained from the non-invasive ethics committee of Atatürk University Faculty of Medicine and official permission will be obtained from the Midwifery Department of Atatürk University Faculty of Health Sciences Midwifery students within the scope of the research will be informed about the research and their informed consent will be obtained before starting to collect research data In addition ethical principles including the principle of confidentiality and protection of confidentiality will be fulfilled by stating that the information obtained from the students will be kept confidential and the principle of respect for autonomy will be fulfilled by recruiting those who want to participate in the research voluntarily
Ensuring volunteer participation and obtaining consent defining the procedures to be taken in the volunteers special situations
Informed voluntary consent given with the completely free will of the students who will participate in the research will be obtained from all volunteers before the research is initiated Information regarding the clinical trial will be recorded in a manner that allows for accurate reporting interpretation and verification of this information
Materials to be Used Storage Conditions Responsibilities if any Records regarding the identity of volunteers will be protected in a way that respects the rules of private life and confidentiality in accordance with the relevant legislation Survey forms will be kept by the principal investigator for at least five years
Statistical Analytical Methods should be clearly stated in this section After yoga practices are completed post-test forms Perceived Stress Scale and Beck Anxiety Scale will be administered The data obtained as a result of the study will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program and statistical analysis will be performed
First of all Kolmogorov-Smirnov Goodness of Fit Test and Shapiro-Wilk will be applied for normality analysis in determining the test to be performed In descriptive statistics arithmetic mean standard deviation median minimum and maximum values will be applied and frequency and percentage will be applied to categorical variables Cronbachs Alpha Coefficient will be calculated to test the internal consistency of the scales Pearson Chi-square Test and Fishers Exact Test will be applied to compare the descriptive characteristics between the study and control groups Within-group paired sample t -test to compare pre- and post-intervention results based on established normality
Paired-Samples T test will be applied In determining the difference between the two group averages t-test will be applied in independent groups The statistical significance level will be accepted as 005
According to the results of a limited number of studies yoga exercises provided positive effects on medicalhealth education students suffering from intense stress and anxiety Erogul et al 2014 Fares and Fares 2016 The limited number of studies conducted in the field of health education on the effects of yoga and meditation focused on students of medicine pharmacy and nursing departments Lemay et al 2019 Ciezar-Andersen et al 2021 On the other hand despite the popularity of yoga in studies mostly in western societies Shohani et al 2018 to our knowledge how it prevents mood disorders in the field of midwifery has not been studied Studies on the effects of yoga are limited in Turkey
Method The total screening of the project will be carried out in 2 stages In the first stage students anxiety and stress levels will be screened After the screening study students demographic characteristics general anxiety and perceived stress levels will be measured According to the data obtained from the scanning study the numbered forms will be put in order and the data obtained will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program According to the data obtained as a result of the screening study participants 72 students who will be sampled according to their anxiety and perceived stress levels will be assigned to the yoga techniques and control group A randomization program wwwrandomizeorg will be used to assign groups
Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in Appointments will be made with students assigned to study groups and yogameditation techniques will begin in a suitable room at the faculty Meetings will be arranged with the yoga and control groups determined during the selection phase after the lesson hours of each class Two separate WhatsApp groups will be created control and yoga groups The responsible researcher has an international yoga training certificate
Yoga and meditation practices 8 weeks once a week 60 minutes
The yoga and meditation intervention will use a 60-minute vinyasa yoga class once a week followed by a guided yoga instruction booklet that takes an average of 30 minutes to read The intervention will be carried out in the last eight weeks of the spring semester when hospital practices are most intense and before the final exams Posttest forms will be filled out the week of final exams The time devoted to meditation will be increased every week for the last two weeks starting with 5 minutes and gradually increasing to 20 minutes in the eighth week
Application Places of the Research It will be carried out in a suitable room at Atatürk University Faculty of Health Sciences Department of Midwifery
Details of Study Design and Method
The planned study is a pre-posttest-posttest randomized controlled experimental study
Sample Size Population and Sample of the Research The population of the study will consist of 724 registered students studying at Atatürk University Faculty of Health Sciences Department of Midwifery 1st 2nd 3rd 4th Grade in the 2023-2024 academic year The maximum number of students sample to be included in the study was calculated using GPower 3197 software Taking Shohani et als 2018 study titled The Effect of Yoga on Stress Anxiety and Depression in Women as a reference it was determined that the effect size of the difference between pre- and post-training individuals in the experimental group who received yoga training was 0351 Accordingly the sample size required for 80 1-β080 power at d 0 351 and α 005 was calculated as 33 people from each group Considering the possibility of midwifery students leaving the groups during the research it was decided that the number of samples in the groups would be 36 based on a 10 loss Students who do not meet the inclusion criteria for the study will not be included in the randomization
Since it is aimed to reach all midwifery students in the survey study no sample selection will be made In order to reach eligible students later after the screening students contact information will be written in the surveys and the scales will be numbered At this stage 72 students who meet the inclusion criteria for this study and volunteer will be divided into control and yoga groups The dependent variables of the study are yoga and meditation Independent variables are anxiety level and perceived stress level Additionally students will have to sign an Informed Consent Form
Collecting Study Data and Recording Data Data Collection Tools Sociodemographic data of midwifery students will be recorded with the Student Identification and Monitoring Form prepared by the research team In addition the Beck Anxiety Scale and Perceived Stress Scale will be used for the screening study before and after the intervention
Student Diagnosis and Monitoring Form ANNEX-1 Student Identification and Follow-up Form to be used in collecting research data A form will be used to inquire about the situations related to name surname class age height weight age marital status place of residence mother and fathers working status and attitude towards exercise This information will be filled in by self-report method
Beck Anxiety Scale BAI ANNEX-2 The scale evaluates the severity of generalized anxiety symptoms This instrument focuses on somatic symptoms of anxiety and contains 21 items Responses are based on a 4-point Likert scale ranging from 0 not at all to 3 severely with a maximum total score of 63 Scores between 0 and 21 indicate low anxiety scores between 22 and 35 indicate moderate anxiety and scores of 36 and above indicate high anxiety The scale was adapted to the Turkish sample by Durak and Palabıyıkoğlu Durak and Palabıyıkoğlu 1994
Perceived Stress Scale PSS Annex-3 It was adapted into Turkish by Eskin et al 2013 Measuring stress is important for scientific research and application activities to be carried out in our country ASÖ reliability coefficient was calculated as 087 Eskin et al 2013 The scale in question consists of 14 items Erci 2006 The scale has two subscales Perception of Insufficient Self-Efficacy and Perception of StressDiscomfort Items 1 2 3 7 11 12 and 14 constitute the Perception of StressDiscomfort dimension and items 4 5 6 8 9 10 and 13 constitute the Perception of Insufficient Self-Efficacy dimension In the scale items 4 5 6 7 9 10 and 13 are scored reversely The total score determined as a result of the scale application indicates the stress level It shows low stress level between 11-26 points medium stress level between 27-41 points and high stress level between 42-56 points
Application of Research The total screening of the project will be carried out in 2 stages In the first stage students anxiety and stress levels will be screened After the screening study students demographic characteristics general anxiety and perceived stress levels will be measured According to the data obtained from the scanning study the numbered forms will be put in order and the data obtained will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program According to the data obtained as a result of the screening study participants 72 students who will be sampled according to their anxiety and perceived stress levels will be assigned to the yoga techniques and control group A randomization program wwwrandomizeorg will be used to assign groups
Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in Appointments will be made with students assigned to study groups and yogameditation techniques will begin in a suitable room at the faculty Meetings will be arranged with the yoga and control groups determined during the selection phase after the lesson hours of each class Two separate WhatsApp groups will be created control and yoga groups The responsible researcher has an international yoga training certificate
Description of Transactions on Working Days Visits if any Students currently studying at Atatürk University Faculty of Health Sciences Department of Midwifery will be informed about the research and invited to participate in the research Research data will be collected from students who agree to participate in the research using a survey form and face-to-face interview technique
Randomization Method Importance if any Randomization will be provided in an online program A randomization program wwwrandomizeorg will be used to assign groups Students assigned to groups through randomization will be contacted via their contact numbers and will be informed about the research and which group they will be in
Ensuring Patient Compliance if any Before starting the research approval will be obtained from the non-invasive ethics committee of Atatürk University Faculty of Medicine and official permission will be obtained from the Midwifery Department of Atatürk University Faculty of Health Sciences Midwifery students within the scope of the research will be informed about the research and their informed consent will be obtained before starting to collect research data In addition ethical principles including the principle of confidentiality and protection of confidentiality will be fulfilled by stating that the information obtained from the students will be kept confidential and the principle of respect for autonomy will be fulfilled by recruiting those who want to participate in the research voluntarily
Ensuring volunteer participation and obtaining consent defining the procedures to be taken in the volunteers special situations
Informed voluntary consent given with the completely free will of the students who will participate in the research will be obtained from all volunteers before the research is initiated Information regarding the clinical trial will be recorded in a manner that allows for accurate reporting interpretation and verification of this information
Materials to be Used Storage Conditions Responsibilities if any Records regarding the identity of volunteers will be protected in a way that respects the rules of private life and confidentiality in accordance with the relevant legislation Survey forms will be kept by the principal investigator for at least five years
Statistical Analytical Methods should be clearly stated in this section After yoga practices are completed post-test forms Perceived Stress Scale and Beck Anxiety Scale will be administered The data obtained as a result of the study will be recorded in the IBM SPSS Statistical Package for the Social Sciences Statistic 21 package program and statistical analysis will be performed
First of all Kolmogorov-Smirnov Goodness of Fit Test and Shapiro-Wilk will be applied for normality analysis in determining the test to be performed In descriptive statistics arithmetic mean standard deviation median minimum and maximum values will be applied and frequency and percentage will be applied to categorical variables Cronbachs Alpha Coefficient will be calculated to test the internal consistency of the scales Pearson Chi-square Test and Fishers Exact Test will be applied to compare the descriptive characteristics between the study and control groups Within-group paired sample t -test to compare pre- and post-intervention results based on established normality
Paired-Samples T test will be applied In determining the difference between the two group averages t-test will be applied in independent groups The statistical significance level will be accepted as 005
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