Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572436
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Multımedia Information Before Amniocentesıs And Chorion Villus Sampling
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of The Effect of Multimedia Information on Anxiety Pain Stress And Fear Levels Before Amniocentesıs And Chorıon Villus Sampling A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is known that the anxiety levels of pregnant women are high before amniocentesis and chorionic villus sampling and it is often neglected The aim of this study is to examine the effects of multimedia information given before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety pain stress and fear levels of pregnant women
Pregnant women who are planned to undergo amniocentesis and chorionic villus sampling are included in this prospective randomized controlled study 90 pregnant women are randomized into two groups as study n45 and control group n45 Pregnant women in the study group are educated with multimedia information before amniocentesis and chorionic villus sampling Pregnant women in the control group are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling Anxiety pain stress and fear levels are assessed immediately before multimedia information and after amniocentesis and chorionic villus sampling
Pregnant women who are planned to undergo amniocentesis and chorionic villus sampling are included in this prospective randomized controlled study 90 pregnant women are randomized into two groups as study n45 and control group n45 Pregnant women in the study group are educated with multimedia information before amniocentesis and chorionic villus sampling Pregnant women in the control group are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling Anxiety pain stress and fear levels are assessed immediately before multimedia information and after amniocentesis and chorionic villus sampling
Detailed Description:
Prenatal invasive tests such as amniocentesis and chorionic villus sampling are performed to exclude or diagnose fetal chromosomal abnormalities Most invasive diagnostic methods cause anxiety and fear in individuals which can be a source of anxiety and depression in individuals Although prenatal invasive tests are a simple and short procedure they can result in serious discomfort and increased pain perception Studies have determined that pregnant women have high anxiety levels before amniocentesis and chorionic villus sampling Anxiety is the most common negative emotion associated with invasive procedures and is also a determinant of mood and pain sensation after the intervention Concerns about pain and potential complications increase the anxiety experienced by pregnant women There are very few studies addressing the psychological aspect associated with prenatal invasive tests Studies have shown that women who are candidates for amniocentesis experience state anxiety and depressive symptoms
Patient education reduces anxiety and worry Various methods are used in patient education Among these verbal education written materialbrochures and multimedia-based education videos compact discs digital versatile discs and the internet are the most commonly used The results regarding which method is more effective in patient education are unclear Education given to pregnant women about the purposes benefits risks and limitations of amniocentesis can reduce anxiety and worry in pregnant women Education increases pregnant womens awareness of the amniocentesis process and its results Patients remember 20 of what is explained 40 of what they read and 80 with multimedia education Multimedia-based education has become more frequently used in patient education due to developments in the field of information technology Multimedia education program is implemented through texts shapes sounds animations and video clips to strengthen the learning activity of users Multimedia not only increases the learning motivation of users but also increases the learning activity Multimedia education has no obstacles in terms of space or time Therefore if the equipment is ready the user can directly access a specific topic in the program at any time and from anywhere
It has been shown that a multimedia education program applied before radiologic imaging endoscopy colonoscopy bronchoscopy invasive cardiac approaches and arthroscopy does not cause cost loss and reduces patient anxiety A multimedia education program applied before birth has been shown to increase pregnant womens knowledge and decision-making skills and reduce their anxiety Multimedia education program before amniocentesis did not provide a significant reduction in the anxiety of pregnant women In another study a multimedia education program before amniocentesis It has been shown to be an easy intervention that can be used to reduce the anxiety of pregnant women
There are no sufficient studies investigating the effects of multimedia information given before amniocentesis on the anxiety levels of pregnant women Furthermore the effectiveness of multimedia information as an intervention to reduce anxiety before chorionic villus sampling has not been investigated The aim of this study is to investigate the effects of a multimedia information video watched before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety pain stress and fear levels of pregnant women
This prospective randomized controlled study is conducted on pregnant women who are scheduled to undergo amniocentesis and chorionic villus sampling by the responsible physician who applied to University Hospital Gynecology and Obstetrics Clinic who did not have known cerebrovascular disease who did not have morbid obesity or heart disease that would prevent the study who did not have cognitive disorders that would prevent communication who did not have a history of stroke or related effects and who agreed to participate in the study Pregnant women who had previously undergone amniocentesis and chorionic villus sampling and who did not agree to participate in the study are excluded from the study Informed consent is obtained from the participants before amniocentesis and chorionic villus sampling procedures are performed We used the CONSORT Consolidated Standards of Reporting Trials checklist while writing our report The study is approved by the University Faculty of Medicine Clinical Research Ethics Committee
The G-power v31 program Universitat Kiel Germany is used to determine the sample size Among the variables measured in the study State-Trait Anxiety Inventory-I STAI-I is used as the basis for determining the sample size When the effect size of the study is taken as f050 α error level as 005 and power 1-β error level as 080 the total sample size is calculated as 90 pregnant women including at least 45 controls When the estimated individual loss rate during the study process is taken as 20 it is planned to include at least 108 pregnant women in the study
Initial evaluations are made for 108 pregnant women included in the study Later 12 pregnant women does not meet the study criteria and 6 pregnant women does not want to participate in the study and therefore dropped out 90 pregnant women are randomized into two groups as study n45 and control group n45 They are randomized into two groups according to a number series consisting of 45 numbers prepared randomly between 1 and 90 through the randomization program randomorg The first of these number series is accepted as the study group and the second as the control group Each pregnant woman included in the study is asked to draw one of the sealed envelopes containing the numbers between 1 and 90 The pregnant woman is assigned to the study or control group according to the number series containing the number drawn The study is completed as study group n45 and control group n45 Since the studyis planned as single-blind pregnant women are not informed about which study or control group they belonged to
Pregnant women in the study group are given multimedia information by watching a short video before amniocentesis and chorionic villus sampling Pregnant women in the control group are not given multimedia information before amniocentesis and chorionic villus sampling but are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling The multimedia information training consist of a 5-minute video containing detailed amniocentesis and chorionic villus sampling application information A 5-minute video is developed by the authors and used for research purposes only The video is designed to provide pregnant women with a comprehensive overview of the amniocentesis and chorionic villus sampling procedure its benefits and potential risks and included real-life images to depict all aspects of the procedure
For the outcome measurements anxiety level pain stress and fear levels are assessed Anxiety level is assessed with STAI-III pain stress and fear levels are assessed with The Visual Analog Scale VAS After being included in the study the initial anxiety pain stress and fear levels of the participants in both groups are assessed Then the participants in the study group watched the information video while the pregnant women in the control group are given a standard verbal explanation After the amniocentesis and chorionic villus sampling procedures the second anxiety pain stress and fear levels of the participants in both groups are assessed
The Personal Information Form is created as a result of a literature review on the subject in order to determine the number of gynecological examinations and birth information of the individuals participating in the sample There are 27 questions in the Personal Information Form Information that cannot be obtained from the pregnant woman will be obtained from the pregnant womans relative or the pregnant womans file measurements such as body mass index calculation that cannot be accessed from the files will be made by the researcher
State-Trait Anxiety Inventory-I and II STAI-I-II is translated into Turkish STAI-I-II is used to measure temporary and permanent anxiety These scales are four-point Likert type consisting of 20 items While STAI-I describes an individuals feelings at a specific moment or under specific conditions STAI-II describes how an individual feels regardless of the situation and conditions The scale includes direct and indirect reverse statements The total scores of the indirect reverse statements are subtracted from the total weighted scores obtained from the direct statements and a fixed value of 50 points is added for STAI-I and 35 points for STAI-II The total score varies between 20 and 80 and scores of 45 and above are indicative of anxiety
VAS is 10 cm long and is applied by marking a point corresponding to the intensity of pain stress and fear felt by the patient on a vertical or horizontal line with different names on both ends The distance between the marked point and the lowest end of the line is measured in centimeters and the numerical value found indicates the intensity of pain stress and fear of the patient 0 indicates no pain stress or fear 1-3 indicates mild pain stress or fear 4-6 indicates moderate pain stress or fear and 7-10 indicates severe pain stress or fear Verbal and numerical assessment scales which are one-dimensional scales are less sensitive and reliable in repeated measurements The sensitivity and selectivity of the scale have been established and it is suitable for use It will be used in the study to evaluate the level of anxiety and fear towards gynecological examination Statistical analysis Data are analyzed using SPSS software version 210 SPSS Inc Chicago IL The one-sample Kolmogorov-Smirnov test is used to evaluate the distribution of variables before test selection Descriptive statistics are expressed as frequency mean and standard deviation Characteristics in the study and control groups are compared using the χ2 test for categorical variables and the Mann-Whitney U test for continuous variables The Wilcoxon signed-rank test is used to compare within-group differences between baseline and post-intervention scores The Mann-Whitney U test is used for between-group comparisons Statistical significance is accepted as p005 Effect sizes are calculated using the mean and standard deviation of the change scores for each group using GPower V317 University of Kiel Kiel Germany The statistical significance level is P 05
Patient education reduces anxiety and worry Various methods are used in patient education Among these verbal education written materialbrochures and multimedia-based education videos compact discs digital versatile discs and the internet are the most commonly used The results regarding which method is more effective in patient education are unclear Education given to pregnant women about the purposes benefits risks and limitations of amniocentesis can reduce anxiety and worry in pregnant women Education increases pregnant womens awareness of the amniocentesis process and its results Patients remember 20 of what is explained 40 of what they read and 80 with multimedia education Multimedia-based education has become more frequently used in patient education due to developments in the field of information technology Multimedia education program is implemented through texts shapes sounds animations and video clips to strengthen the learning activity of users Multimedia not only increases the learning motivation of users but also increases the learning activity Multimedia education has no obstacles in terms of space or time Therefore if the equipment is ready the user can directly access a specific topic in the program at any time and from anywhere
It has been shown that a multimedia education program applied before radiologic imaging endoscopy colonoscopy bronchoscopy invasive cardiac approaches and arthroscopy does not cause cost loss and reduces patient anxiety A multimedia education program applied before birth has been shown to increase pregnant womens knowledge and decision-making skills and reduce their anxiety Multimedia education program before amniocentesis did not provide a significant reduction in the anxiety of pregnant women In another study a multimedia education program before amniocentesis It has been shown to be an easy intervention that can be used to reduce the anxiety of pregnant women
There are no sufficient studies investigating the effects of multimedia information given before amniocentesis on the anxiety levels of pregnant women Furthermore the effectiveness of multimedia information as an intervention to reduce anxiety before chorionic villus sampling has not been investigated The aim of this study is to investigate the effects of a multimedia information video watched before invasive prenatal diagnostic tests such as amniocentesis and chorionic villus sampling on the anxiety pain stress and fear levels of pregnant women
This prospective randomized controlled study is conducted on pregnant women who are scheduled to undergo amniocentesis and chorionic villus sampling by the responsible physician who applied to University Hospital Gynecology and Obstetrics Clinic who did not have known cerebrovascular disease who did not have morbid obesity or heart disease that would prevent the study who did not have cognitive disorders that would prevent communication who did not have a history of stroke or related effects and who agreed to participate in the study Pregnant women who had previously undergone amniocentesis and chorionic villus sampling and who did not agree to participate in the study are excluded from the study Informed consent is obtained from the participants before amniocentesis and chorionic villus sampling procedures are performed We used the CONSORT Consolidated Standards of Reporting Trials checklist while writing our report The study is approved by the University Faculty of Medicine Clinical Research Ethics Committee
The G-power v31 program Universitat Kiel Germany is used to determine the sample size Among the variables measured in the study State-Trait Anxiety Inventory-I STAI-I is used as the basis for determining the sample size When the effect size of the study is taken as f050 α error level as 005 and power 1-β error level as 080 the total sample size is calculated as 90 pregnant women including at least 45 controls When the estimated individual loss rate during the study process is taken as 20 it is planned to include at least 108 pregnant women in the study
Initial evaluations are made for 108 pregnant women included in the study Later 12 pregnant women does not meet the study criteria and 6 pregnant women does not want to participate in the study and therefore dropped out 90 pregnant women are randomized into two groups as study n45 and control group n45 They are randomized into two groups according to a number series consisting of 45 numbers prepared randomly between 1 and 90 through the randomization program randomorg The first of these number series is accepted as the study group and the second as the control group Each pregnant woman included in the study is asked to draw one of the sealed envelopes containing the numbers between 1 and 90 The pregnant woman is assigned to the study or control group according to the number series containing the number drawn The study is completed as study group n45 and control group n45 Since the studyis planned as single-blind pregnant women are not informed about which study or control group they belonged to
Pregnant women in the study group are given multimedia information by watching a short video before amniocentesis and chorionic villus sampling Pregnant women in the control group are not given multimedia information before amniocentesis and chorionic villus sampling but are given brief verbal information about the procedure before amniocentesis and chorionic villus sampling The multimedia information training consist of a 5-minute video containing detailed amniocentesis and chorionic villus sampling application information A 5-minute video is developed by the authors and used for research purposes only The video is designed to provide pregnant women with a comprehensive overview of the amniocentesis and chorionic villus sampling procedure its benefits and potential risks and included real-life images to depict all aspects of the procedure
For the outcome measurements anxiety level pain stress and fear levels are assessed Anxiety level is assessed with STAI-III pain stress and fear levels are assessed with The Visual Analog Scale VAS After being included in the study the initial anxiety pain stress and fear levels of the participants in both groups are assessed Then the participants in the study group watched the information video while the pregnant women in the control group are given a standard verbal explanation After the amniocentesis and chorionic villus sampling procedures the second anxiety pain stress and fear levels of the participants in both groups are assessed
The Personal Information Form is created as a result of a literature review on the subject in order to determine the number of gynecological examinations and birth information of the individuals participating in the sample There are 27 questions in the Personal Information Form Information that cannot be obtained from the pregnant woman will be obtained from the pregnant womans relative or the pregnant womans file measurements such as body mass index calculation that cannot be accessed from the files will be made by the researcher
State-Trait Anxiety Inventory-I and II STAI-I-II is translated into Turkish STAI-I-II is used to measure temporary and permanent anxiety These scales are four-point Likert type consisting of 20 items While STAI-I describes an individuals feelings at a specific moment or under specific conditions STAI-II describes how an individual feels regardless of the situation and conditions The scale includes direct and indirect reverse statements The total scores of the indirect reverse statements are subtracted from the total weighted scores obtained from the direct statements and a fixed value of 50 points is added for STAI-I and 35 points for STAI-II The total score varies between 20 and 80 and scores of 45 and above are indicative of anxiety
VAS is 10 cm long and is applied by marking a point corresponding to the intensity of pain stress and fear felt by the patient on a vertical or horizontal line with different names on both ends The distance between the marked point and the lowest end of the line is measured in centimeters and the numerical value found indicates the intensity of pain stress and fear of the patient 0 indicates no pain stress or fear 1-3 indicates mild pain stress or fear 4-6 indicates moderate pain stress or fear and 7-10 indicates severe pain stress or fear Verbal and numerical assessment scales which are one-dimensional scales are less sensitive and reliable in repeated measurements The sensitivity and selectivity of the scale have been established and it is suitable for use It will be used in the study to evaluate the level of anxiety and fear towards gynecological examination Statistical analysis Data are analyzed using SPSS software version 210 SPSS Inc Chicago IL The one-sample Kolmogorov-Smirnov test is used to evaluate the distribution of variables before test selection Descriptive statistics are expressed as frequency mean and standard deviation Characteristics in the study and control groups are compared using the χ2 test for categorical variables and the Mann-Whitney U test for continuous variables The Wilcoxon signed-rank test is used to compare within-group differences between baseline and post-intervention scores The Mann-Whitney U test is used for between-group comparisons Statistical significance is accepted as p005 Effect sizes are calculated using the mean and standard deviation of the change scores for each group using GPower V317 University of Kiel Kiel Germany The statistical significance level is P 05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None