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

NCT07030530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-09-26

No results posted yet for this study

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. 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.

Conditions

  • Pregnancy
  • State Anxiety

Interventions

DEVICE

Virtual Glasses Group

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.

OTHER

Mandala Coloring activity group;

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

Sponsors & Collaborators

  • Fatma Keskin Töre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-07-15
Completion
2025-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030530 on ClinicalTrials.gov