Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391112
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-04-25
Brief Title:
The Effect of Painting-Based Art Intervention on Maternal Anxiety and Fetal Parameters
Sponsor:
Osmaniye Korkut Ata University
Organization:
Osmaniye Korkut Ata University
Study Overview
Official Title:
Painting-Based Art of the Fetus During Non-Stress Testing Effect of Intervention on Maternal Anxiety and Fetal Parameters Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
It is observed that art-based programs one of the non-pharmacological methods play an active role in improving the health and well-being of pregnant women and reducing anxiety stress and depression This shows that arts-based experiences offer women a unique opportunity to explore all dimensions of the transition to motherhood When the literature is examined it is seen that art-based interventions are used in birth units neonatal intensive care and high-risk pregnancy units However no study has been found in which it was applied during the NST procedure Therefore the aim of our study is to examine the effect of picture-based art intervention on the fetus during the Non-Stress Test on maternal anxiety and fetal parameters
Detailed Description:
Hypotheses
H1 Painting-Based Art Intervention positively affects NST results H2 Painting-Based Art Intervention reduces the level of maternal anxiety
Study protocol methods and procedures to be applied
Type of Research
The research was planned as a randomized controlled clinical trial
Place and Time of Research
The research will be conducted at the NST polyclinic of Malatya Training and Research Hospital between January 2024 and May 2024
Population and Sample of the Research The population of the research will consist of pregnant women who have applied to the NST polyclinic have had at least one live birth have had NST before do not have any psychiatric or risky pregnancy diagnoses do not have communication problems and are older than the 32nd week of pregnancy
There are 6 NST devices in the NST polyclinic where the research will be conducted The assignment of pregnant women to the experimental and control groups will be made according to the device on which the NST procedure will be performed It was decided by lottery method to perform the procedures on pregnant women in the experimental or control group with the devices numbered 1-6 In the draw held before the start of the research it was determined that the pregnant women who would be included in the Painting-Based Art Intervention group with devices numbered 1 4 6 and the pregnant women who would be included in the control group with devices numbered 2 3 5 would undergo NST procedure In order to prevent contamination between the experimental and control groups in the research pregnant women who first form the control and then the experimental groups will be included in the study
Criteria for inclusion in the study
Not having any risk factors during pregnancy preeclampsia eclampsia intrauterine growth retardation PROM gestational diabetes and hypertension placenta previa twin pregnancy etc
Lack of uterine contraction No cardiovascular disease diagnosed in the fetus Pregnant women must be between the ages of 18-35 Conditions to be met before and during the NST procedure Not having smoked or consumed alcohol at least two hours before the NST procedure Having urinated before the NST procedure Giving the pregnant woman the left side lateral position Blood pressure values measured just before the NST procedure should be within the normal range
Exclusion criteria for the study
Any complications in the pregnancy Any complications in the fetus Refusal to accept the final test to be performed Data Collection Process Data Collection Tools Data will be collected using the Introductory Information Form State Anxiety Scale and Record Form for NST Findings developed by the researchers using the literature
Participant Introduction Form The Participant Introduction Form consists of questions that determine socio-demographic and obstetric characteristics knowledge about NST findings and drawing-based intervention
NST Findings Record Form NST Findings Registration Form is a form used by researchers to evaluate NST results of pregnant women This form contains data recording the findings of NST of pregnant women
Evaluation of NST Findings Record Form All pregnant women who agree to participate in the study will undergo NST with the NST device in the hospital NST results of pregnant women will be evaluated by researchers
As reactive NST In the presence of at least two accelerations that last for at least 15 seconds and are 15 beatsminute more than the baseline beat within the 20-minute period during which the electronic fetal heart rate traces are printed the result of the test will be considered as reactive NST
As nonreactive NST The absence of at least two accelerations that last for at least 15 seconds and are 15 beatsminute more than the baseline beat within the 20-minute period during which the electronic fetal heart rate traces are printed in the presence of severe variable decelerations and late decelerations or continuous fetal tachycardia of 160 beatsminute and above when the initial traces are normal If it develops the result will be evaluated as nonreactive NST
State Anxiety Scale The state-trait anxiety scale developed by Spielberg and his colleagues in 1964 to measure the anxiety levels of normal and abnormal individuals was adapted into Turkish by Öner and Le Compte The state anxiety part of the scale which consists of two parts will be used There are 20 statements in both scales and the answer options include four options each ranging from 1 to 4
The scales contain both direct straight expressions and reversed expressions While direct expressions express negative emotions tInverted expressions reflect positive emotions In the State Anxiety Scale these reversed statements are items 1 2 5 8 10 11 15 16 19 and 20 The statements in the scale are answered by selecting the options 1 not at all 2 a little 3 a lot and 4 completely in order to evaluate the emotions or behaviors according to the severity of the experiences The total score obtained varies between 20 and 80 a high score indicates a high level of anxiety
H1 Painting-Based Art Intervention positively affects NST results H2 Painting-Based Art Intervention reduces the level of maternal anxiety
Study protocol methods and procedures to be applied
Type of Research
The research was planned as a randomized controlled clinical trial
Place and Time of Research
The research will be conducted at the NST polyclinic of Malatya Training and Research Hospital between January 2024 and May 2024
Population and Sample of the Research The population of the research will consist of pregnant women who have applied to the NST polyclinic have had at least one live birth have had NST before do not have any psychiatric or risky pregnancy diagnoses do not have communication problems and are older than the 32nd week of pregnancy
There are 6 NST devices in the NST polyclinic where the research will be conducted The assignment of pregnant women to the experimental and control groups will be made according to the device on which the NST procedure will be performed It was decided by lottery method to perform the procedures on pregnant women in the experimental or control group with the devices numbered 1-6 In the draw held before the start of the research it was determined that the pregnant women who would be included in the Painting-Based Art Intervention group with devices numbered 1 4 6 and the pregnant women who would be included in the control group with devices numbered 2 3 5 would undergo NST procedure In order to prevent contamination between the experimental and control groups in the research pregnant women who first form the control and then the experimental groups will be included in the study
Criteria for inclusion in the study
Not having any risk factors during pregnancy preeclampsia eclampsia intrauterine growth retardation PROM gestational diabetes and hypertension placenta previa twin pregnancy etc
Lack of uterine contraction No cardiovascular disease diagnosed in the fetus Pregnant women must be between the ages of 18-35 Conditions to be met before and during the NST procedure Not having smoked or consumed alcohol at least two hours before the NST procedure Having urinated before the NST procedure Giving the pregnant woman the left side lateral position Blood pressure values measured just before the NST procedure should be within the normal range
Exclusion criteria for the study
Any complications in the pregnancy Any complications in the fetus Refusal to accept the final test to be performed Data Collection Process Data Collection Tools Data will be collected using the Introductory Information Form State Anxiety Scale and Record Form for NST Findings developed by the researchers using the literature
Participant Introduction Form The Participant Introduction Form consists of questions that determine socio-demographic and obstetric characteristics knowledge about NST findings and drawing-based intervention
NST Findings Record Form NST Findings Registration Form is a form used by researchers to evaluate NST results of pregnant women This form contains data recording the findings of NST of pregnant women
Evaluation of NST Findings Record Form All pregnant women who agree to participate in the study will undergo NST with the NST device in the hospital NST results of pregnant women will be evaluated by researchers
As reactive NST In the presence of at least two accelerations that last for at least 15 seconds and are 15 beatsminute more than the baseline beat within the 20-minute period during which the electronic fetal heart rate traces are printed the result of the test will be considered as reactive NST
As nonreactive NST The absence of at least two accelerations that last for at least 15 seconds and are 15 beatsminute more than the baseline beat within the 20-minute period during which the electronic fetal heart rate traces are printed in the presence of severe variable decelerations and late decelerations or continuous fetal tachycardia of 160 beatsminute and above when the initial traces are normal If it develops the result will be evaluated as nonreactive NST
State Anxiety Scale The state-trait anxiety scale developed by Spielberg and his colleagues in 1964 to measure the anxiety levels of normal and abnormal individuals was adapted into Turkish by Öner and Le Compte The state anxiety part of the scale which consists of two parts will be used There are 20 statements in both scales and the answer options include four options each ranging from 1 to 4
The scales contain both direct straight expressions and reversed expressions While direct expressions express negative emotions tInverted expressions reflect positive emotions In the State Anxiety Scale these reversed statements are items 1 2 5 8 10 11 15 16 19 and 20 The statements in the scale are answered by selecting the options 1 not at all 2 a little 3 a lot and 4 completely in order to evaluate the emotions or behaviors according to the severity of the experiences The total score obtained varies between 20 and 80 a high score indicates a high level of anxiety
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