The Effect of Using Nature Sounds and Virtual Reality Dur... | NCT07512999

NCT07512999

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Detailed Description

Pregnancy is a multidimensional process characterized not only by physiological changes but also by the restructuring of social roles and psychological adaptation. The changes that occur during this process affect both the mother and the fetus. Increased maternal stress and anxiety may influence fetal development through hormonal mechanisms. Therefore, regular and holistic monitoring of pregnancy is important. Antenatal care is a systematic evaluation process aimed at protecting maternal and fetal health and identifying risk factors. One of the frequently used non-invasive methods for assessing fetal health is the non-stress test. It is widely used because it is easy to administer and considered safe. The test evaluates the relationship between fetal heart rate, fetal movements, and uterine contractions. A reactive result indicates that the fetus is in good condition, whereas a non-reactive result may require further evaluation. Although the non-stress test is non-invasive and painless, it generally lasts at least 20 minutes, and remaining in the same position may lead to hypotension, discomfort, and anxiety. Increased maternal anxiety may affect fetal heart rate patterns, increase false-positive rates, and result in unnecessary interventions. Therefore, non-pharmacological interventions aimed at increasing maternal comfort and reducing anxiety during the NST process are important. Nature sounds may reduce perceived stress by promoting relaxation, while virtual reality may decrease anxiety and increase satisfaction by diverting attention away from the environment. The aim of this study is to determine the effects of using nature sounds and virtual reality during the non-stress test on fetal well-being, maternal anxiety, comfort, and satisfaction. The study sample will consist of all pregnant women admitted to the Non-Stress Test (NST) unit. A total of 150 women will be included in the sample: 50 for the virtual reality group, 50 for the nature sounds group, and 50 for the control group. Personal Information Form, Non Stress Test Evaluation Form, Visual Analog Scale for Satisfaction (VAS-Satisfaction), Visual Analog Scale for Comfort (VAS-Comfort), Spielberger State-Trait Anxiety Inventory (STAI) Scale, Intervention for the experimental group, the Evaluation Form (Virtual reality, Nature sounds) will be used in data collection.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual reality group	Experimental	After obtaining written informed consent from the women, data collection forms will be administered (Personal Information Form, Spielberger State-Trait Anxiety Inventory-STAI). This group will include 50 pregnant women. Following the administration of the survey form, the virtual reality headset will be introduced. The headset will be fitted before the procedure begins, and women will be instructed on how to continue watching the video while wearing the headset during the procedure. Women treated with virtual reality will be presented with videos of natural scenes (forest and sea) accompanied by nature sounds and asked to watch. After the procedure is complete, final tests will be conducted: Non-Stress Test Evaluation Form, Visual Analog Scale for Satisfaction (VAS-Satisfaction), Visual Analog Scale for Comfort (VAS-Comfort), Spielberger State-Trait Anxiety Inventory (STAI) Scale, Intervention for the experimental group, and the Evaluation Form (virtual reality, nature sounds).	Behavioral: Virtual Reality
Nature sounds group	Experimental	After obtaining written informed consent from the women, data collection forms will be administered (Personal Information Form, Spielberger State-Trait Anxiety Inventory-STAI). This group will include 50 pregnant women. Women in the nature sounds group will be provided with the opportunity to listen to relaxing nature sounds (sea, rain, wind, river, birds) using MP3 players and headphones, according to their preferences. After the procedure is complete, final tests will be conducted: Non-Stress Test Evaluation Form, Visual Analog Scale for Satisfaction (VAS-Satisfaction), Visual Analog Scale for Comfort (VAS-Comfort), Spielberger State-Trait Anxiety Inventory (STAI) Scale, Intervention for the experimental group, and the Evaluation Form (virtual reality, nature sounds).	Behavioral: Nature sounds
Control group	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality	Behavioral	Women treated with virtual reality will be presented with videos of natural scenes (forest and sea) accompanied by nature sounds and asked to watch. The headset will be fitted before the procedure begins, and women will be instructed on how to continue watching the video while wearing the headset during the procedure.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
State-Trait Anxiety Inventory (STAI) Scale	The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87	Before the non-stress test and after the procedure is completed (20 minutes after the start of the procedure)
Visual Analog Scale for Comfort (VAS-Comfort)	The Visual Analog Scale (VAS) will be used to determine the comfort levels of the participants. Developed by Price et al. in 1983 for the purpose of evaluating subjective pain, the VAS is an easy-to-apply measurement method whose validity and reliability are accepted in the international literature (Price et al., 1987; Akbay, 2026). Based on the individual's subjective evaluation, the VAS is used not only to determine the level of pain but also to evaluate subjective conditions such as fatigue and discomfort. The Visual Analog Scale (VAS) is a 10 cm long scale that can be arranged vertically or horizontally, with endpoints defined by different expressions. In this study, to evaluate the comfort levels of individuals, the leftmost end of the scale will be defined as "0 = Not comfortable at all" and the rightmost end as "10 = Very comfortable". To make the scale more understandable and applicable, vertical lines and numerical values will be used on the horizontal line.	After the non-stress test is completed (20 minutes after the start of the procedure)
Visual Analog Scale for Satisfaction (VAS-Satisfaction)	The VAS satisfaction form will be used to determine the satisfaction levels of the participants. The Visual Analog Scale (VAS) is a reliable and easily applicable measurement method with endpoints defined by different expressions, and is 10 cm long. VAS is also used to evaluate subjective states such as satisfaction. In this study, to evaluate the satisfaction levels of individuals, the leftmost end of the scale will be defined as "0 = Not satisfied at all" and the rightmost end as "10 = Very satisfied". In order to make the scale more understandable and applicable, vertical lines and numerical values will be used on the horizontal line.

Eligibility Module

Name	Role	Phone	Extension	Email
Elif KETEN EDİS, Assoc.Prof, PhD	Contact	+90 358 211 50 05	4802	elifketen05@gmail.com
Sevgi ARSLAN, BSc, RN	Contact	+90 358 211 50 05		sevgiedaarslan@gmail.com

Name	Affiliation	Role
Elif Keten Edis, PhD	Amasya University	Study Director

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

After obtaining written informed consent from the women, data collection forms will be administered (Personal Information Form, Spielberger State-Trait Anxiety Inventory-STAI). This group will include 50 pregnant women. Women in the control group will not receive any intervention. After the non-stress test is complete, final tests will be conducted: Non-Stress Test Evaluation Form, Visual Analog Scale for Satisfaction (VAS-Satisfaction), Visual Analog Scale for Comfort (VAS-Comfort), Spielberger State-Trait Anxiety Inventory (STAI) Scale, Intervention for the experimental group, and the Evaluation Form (virtual reality, nature sounds).