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

NCT07030530 | Completed

• 1 other identifier: 2025/17
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

State Anxiety; Pregnancy; Mandala Coloring; Non-Stress Test; Virtual Reality

Outcome Measures

Primary Outcomes (1)

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

  Reactive Non-Stress Test Results

  20 minutes later

Study Arms (3)

Virtual Glasses Group

EXPERIMENTAL

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. Virtual reality videos are recommended to be watched for 5-20 minutes as they may cause nausea and vomiting. Since this study includes pregnant women, it is planned to play the virtual reality videos for 5-10 minutes.

Device: Virtual Glasses Group

Mandala Coloring activity group

EXPERIMENTAL

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.(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.

Other: Mandala Coloring activity group;

Control Group

NO INTERVENTION

Pregnant 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.

Interventions

Virtual Glasses Group DEVICE

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.

Virtual Glasses Group

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

Mandala Coloring activity group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatma Keskin Töre: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: June 30, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

TU (1)