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PregnancyNCT07030530

Virtual Reality Video and Mandala Coloring Activity on Anxiety Levels, Satisfaction and Non-Stress Test Results of Pregnant Women

A study testing Virtual Glasses Group and Mandala Coloring activity group; in people with Pregnancy and State Anxiety, run by Fatma Keskin Töre at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-stress testing (NST) is one of the most commonly used non-invasive tests to assess fetal health. NST is widely used because it is non-invasive and easy to interpret. However, although it is a painless procedure, pregnant women may experience anxiety during the procedure. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, State Anxiety
What is being tested?
Virtual Glasses Group and Mandala Coloring activity group;
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Jun 2025to 1 Aug 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be over 18 years of age,
  • Not having any chronic or metabolic disease (completely healthy pregnant women)
  • Not having any psychiatric illne

Who cannot join

  • -Multiple pregnancy
  • Contraction on NST communication and visual impairment, uterine contraction as a result of NST,
  • Have any chronic disease (such as diabetes mellitus, hypertension, heart failure),
  • Have pregnancy complications (such as pre-eclampsia, gestational diabetes, Rh incompatibility),
  • History of infertility and conceived with assisted reproductive techniques,
  • The fetus has an identified problem (such as anomaly, intrauterine growth retardation and cardiovascular disease),
  • Pregnant women who provided false or incomplete information were excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kahramanmaraş Sütçü İmam Üniversitesi

    Kahramanmaraş

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Virtual Reality Video and Mandala Coloring Activity on Anxiety Levels, Satisfaction and Non-Stress Test Results of Pregnant Women

Non-stress testing (NST) is one of the most commonly used non-invasive tests to assess fetal health. NST is widely used because it is non-invasive and easy to interpret. However, although it is a painless procedure, pregnant women may experience anxiety during the procedure. The high level of anxiety experienced by the pregnant woman during the NST procedure affects the test result and may increase the rate of non-reactive NST, leading to misinterpretation. These false positive rates of NST lead to an increase in cesarean section rates. Recent studies have shown that methods that increase fetal movements and shorten the duration of NST are used. When the literature is examined, it is seen that non-pharmacological methods such as music therapy, virtual reality and abdominal touching applied during the NST procedure reduce the anxiety of pregnant women and positively affect the NST results. With this proposed project, it is aimed to determine the Effect of Virtual Reality Video and Mandala Coloring Activity on Anxiety Levels, Satisfaction and Non-Stress Test Results of Pregnant Women.

The study is a randomized controlled experimental type study in pretest-posttest design and the population of the study will consist of pregnant women who applied to Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Obstetrics and Gynecology Outpatient Clinic and were referred to NST. Simple randomization method will be used while sampling the pregnant women. The power analysis was performed under 95% power (1-β), number of groups=3 and α=0.05, and in the light of these parameters, it was concluded that a sample size of at least 90 participants was required for this study. In case of data loss, it was envisaged to increase the sample size by 20%. Accordingly, the project was planned to be conducted with a total of n=108 participants, with 36 pregnant women in each group. After the ethics committee permission, institutional permission will be obtained from Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. Data will be collected using the "Personal Introduction Form", "State Anxiety Scale", "NST findings record form" in which NST findings are recorded, and Visual Analog Scale-Satisfaction Form to evaluate their satisfaction after NST.

Read the detailed description

In the first part of the study, pregnant women who apply to Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Obstetrics and Gynecology Outpatient Clinic and are referred to NST and meet the inclusion criteria will be informed about the project and verbal and written consent will be obtained. In this direction, survey questions will be directed to pregnant women who agree to participate in the study. In the study, pre-test data will be obtained with 13-question Participant Introduction Form and 20-question State Anxiety Scale forms. Post-test data will be obtained after the NST procedure is completed for the experimental groups, the researcher will ask the State Anxiety Scale, VAS-Satisfaction form by face-to-face interview method and the NST Findings Record Form will be filled by the researcher.

and the explanations made to the pregnant women before the procedure will be made in a room outside the NST room.

Randomization Pregnant women included in the study will be randomized with the single-blinded randomized rule. Randomization will be done by using the random integer generator method in the numbers subheading of the random.org website, and three-group columns will be created with numbers from 1 to 108. At the beginning of the study, lots will be drawn to determine which of the 3 columns will be the experimental groups and which will be the control group. When there is a participant who meets the inclusion criteria, the participant will be included in whichever group the next number is in.

Data Collection Tools Data will be collected using the Personal Introduction Form, which determines the socio-demographic and obstetric characteristics of women and their knowledge about NST, the State Anxiety Scale, the NST Findings Record Form, which includes the findings related to NST, which allows the researchers to evaluate the NST result of pregnant women, and the Visual Analog Scale (VAS) - Satisfaction Form to evaluate their satisfaction after NST.

Personal Introduction Form This form was created by the researchers to determine women's sociodemographic (age, educational status, etc.), obstetric characteristics (pregnancy, abortion and number of living children) and knowledge about NST (receiving information about NST before, from whom they received the information, reason for NST withdrawal, etc.).

State Anxiety Scale (SAS) The adaptation of the State-Trait Anxiety Scale, which was developed by Spielberg et al. in 1970 to measure anxiety level, into Turkish was performed by Öner and Le Compte (1983). The scale consists of two parts and the State Anxiety part was used in this study. There are 20 statements in the scale . The scales include both direct statements and inverted statements. While direct statements express negative emotions, inverted statements reflect positive emotions. In the State Anxiety Scale, these reversed statements are items numbered 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The statements in the scale are answered by marking (1) not at all, (2) a little, (3) a lot, and (4) completely in order to evaluate emotions or behaviors according to the severity of the experiences. The total score obtained varies between 20 and 80. A high score on the scale indicates a high level of anxiety. The Cronbach alpha value of the scale was found between 0.94 and 0.96 .

NST Findings Record Form The NST Findings Record Form is a form used by researchers to evaluate the NST results of pregnant women. This form contains data in which the findings of NST of pregnant women are recorded .

Evaluation of the NST Findings Record Form; NST results of pregnant women were evaluated by the researchers. As reactive NST, the result of the test will be accepted as reactive NST in the presence of at least two accelerations lasting at least 15 seconds and 15 beats/minute more than the baseline beat within 20 minutes of electronic fetal heart rate tracings . As nonreactive NST, the result of the test will be considered as nonreactive NST in the absence of at least two accelerations lasting at least 15 seconds and lasting more than 15 beats/min more than the baseline beat within 20 minutes of printing electronic fetal heart rate tracings, in the presence of severe variable deselerations and late deselerations, or in the development of continuous fetal tachycardia of 160 beats/min or more when the baseline tracings are normal .

Visual Analog Scale (VAS)- Satisfaction Form The scale developed by Price et al. (1983) is a very simple, easy-to-administer measurement method used to measure subjective experiences. It is a measurement tool that is evaluated by individuals marking a horizontal or vertical line of 10 cm or 100 mm, with one end indicating "very good" and the other end indicating "very bad". This line is only straight

Being tested
Virtual Glasses Group, Mandala Coloring activity group;
Keywords
State Anxiety, Pregnancy, Mandala Coloring, Non-Stress Test, Virtual Reality
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Glasses GroupDevice

    Virtual Glasses Group; Pregnant women in the virtual reality group will be shown a virtual reality video in VR mode via smartphone during the NST procedure (with the pregnant woman lying on her left side). It will be watched with virtual reality glasses containing nature sounds (streams, birds, etc.). Pregnant women will be informed about the use of virtual reality goggles before being shown the virtual reality video and will be asked to stop watching the video if they feel any discomfort. It is recommended to watch virtual reality videos for 5-20 minutes because they may cause nausea and vomiting (23). Since this study includes pregnant women, it is planned to play the virtual reality videos for 5-10 minutes.

  • Mandala Coloring activity group;Other

    Mandala Coloring activity group; In studies examining the effect of art therapy on the reduction of psychological symptoms, it has been shown that the use of round patterns is more effective in symptom management. In line with these studies, ready-made mandala coloring templates with round shapes will be used in our study. Each participant will be asked to choose one of the mandala coloring templates. Each participant will be given colored pencils and asked to color the mandala template of their choice during the NST

Study groups in NCT07030530
Study groupRoleWhat they receive
Mandala Coloring activity groupExperimentalMandala Coloring activity group; In studies examining the effect of art therapy on the reduction of psychological symptoms, it has been shown that the use of round patterns is more effective in symptom management.(24) In line with these studies, ready-made mandala coloring templates with round shapes will be used in our study (25,26). Each participant will be asked to choose one of the mandala coloring templates. Each participant will be given colored pencils and asked to color the mandala template of their choice during the NST (27,28). After the procedure is completed, the pregnant women will be asked the State Anxiety Scale, VAS-Satisfaction form and the NST Findings Record Form will be completed by the researcher.
Receives: Other: Mandala Coloring activity group;
Control GroupNo interventionPregnant women in the control group will undergo standard outpatient clinic practice. Pregnant women in the control group will be asked Personal Information Form and State Anxiety Scale form questions in the pretest. After the procedure is completed, the pregnant women will be asked the State Anxiety Scale, VAS-Satisfaction form in the post-test and the NST Findings Record Form will be completed by the researcher.
Virtual Glasses GroupOtherPregnant women assigned to the Virtual Reality Group will watch a virtual reality (VR) video through a VR headset connected to a smartphone during the non-stress test (NST) procedure while lying in the left lateral position. The VR video will feature natural scenery accompanied by relaxing nature sounds, such as flowing water and birdsong. Before the intervention, participants will receive instructions on the use of the VR headset and will be informed that they may discontinue viewing the video at any time if they experience any discomfort. Since VR exposure may cause nausea or vomiting, the recommended viewing duration is 5-20 minutes. As this study involves pregnant women, the VR video will be presented for 5-10 minutes.
Receives: Device: Virtual Glasses Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Virtual Reality Video and Mandala Coloring Activity on Non-Stress Test Results

    Reactive Non-Stress Test Results

    Measured: 20 minutes later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completion15 Jul 2025
  4. Study completion1 Aug 2025

Resources

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
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030530
Sponsor's protocol ID
2025/17
Status last verified
Jul 2026
First submitted
12 Jun 2025
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Glasses Group and Mandala Coloring activity group; in people with Pregnancy and State Anxiety, run by Fatma Keskin Töre 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 3 inclusion and 7 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 2026. 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?

The Effect of Virtual Reality Video and Mandala Coloring Activity on Non-Stress Test Results (time frame: 20 minutes later). 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 2026.

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