Pregnancy TestsNCT06391112
The Effect of Painting-Based Art Intervention on Maternal Anxiety and Fetal Parameters
A study testing Painting Based Art intervention in people with Pregnancy Tests, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Pregnancy Tests
- What is being tested?
- Painting Based Art intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Not having any risk factors during pregnancy
- Lack of uterine contraction
- No cardiovascular disease diagnosed in the fetus
- Pregnant women must be between the ages of 18-35
Who cannot join
- Any complications in the pregnancy
- Any complications in the fetus
- Refusal to accept the final test to be performed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turgut Özal Medical Training and Research Hospital
Malatya, 44000
About this study
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
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.
Read the 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 beats/minute 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 beats/minute 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 beats/minute 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.
- Conditions
- Pregnancy Tests
- Being tested
- Painting Based Art intervention
- Keywords
- Art Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Painting Based Art interventionOther
Painting Based Art Effect of Intervention on Maternal Anxiety and Fetal Parameters
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Pregnant women in the control group will receive standard outpatient clinic treatment. |
| Experimental group | Experimental | In the research, pregnant women in the Painting-Based Art Intervention group will be asked to imagine their own babies during the NST procedure and after imagining them, they will be asked to draw them in a drawing book. Receives: Other: Painting Based Art intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1983). 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.
Measured: one week
Secondary outcomes (1)
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 NST findings of pregnant women.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2024
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is a control and experimental group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANSU AĞRALI, Osmaniye Korkut Ata University
- Investigators
- Gülçin Nacar, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391112
- Sponsor's protocol ID
- OsmaniyeKAU-SBF-CA-01
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06391112
- Acronym / sponsor ID
- OsmaniyeKAU-SBF-CA-01
- Conditions
- Pregnancy Tests
- Keywords
- Art Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 beats/minute 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 beats/minute 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 beats/minute 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There is a control and experimental group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Pregnant women in the control group will receive standard outpatient clinic treatment. |
| Experimental group | Experimental | Other: Painting Based Art interventionIn the research, pregnant women in the Painting-Based Art Intervention group will be asked to imagine their own babies during the NST procedure and after imagining them, they will be asked to draw them in a drawing book. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Not having any risk factors during pregnancy
- Lack of uterine contraction
- No cardiovascular disease diagnosed in the fetus
- Pregnant women must be between the ages of 18-35
Key exclusion criteria (3 listed)
- Any complications in the pregnancy
- Any complications in the fetus
- Refusal to accept the final test to be performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Painting Based Art interventionPainting Based Art Effect of Intervention on Maternal Anxiety and Fetal Parameters | Other | Experimental group |
Primary outcome
State Anxiety Scale
Time frame: one week
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 (1983). 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.
1 secondary outcome
NST Findings Record Form
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülçin Nacar study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Painting Based Art intervention in people with Pregnancy Tests, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.