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Completed

NCT Number: NCT07545863

Effect of Using Virtual Glasses on Anxiety, Pain and Comfort During Uterine Tonus Assessment

This randomized controlled experimental study aimed to determine the effect of using virtual glasses during uterine tone assessment on anxiety, pain and comfort. The hypotheses of this study were determined as follows:

H1-a: Using virtual reality glasses during uterine tone assessment affects anxiety.

H1-b: Using virtual reality glasses during uterine tone assessment affects pain.

H1-c: Using virtual reality glasses during uterine tone assessment affects comfort.

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Key information

Conditions

Pregnancy Related Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, None Selected, 44000, Turkey (Türkiye)

About this study

Data collection tools will be collected from women who gave birth in the Maternity Ward of Malatya Education and Research Hospital between February 2024 and February 2025 and who agreed to participate in the study, using the face-to-face interview method on weekdays by the researchers. Data will be collected in two stages. The application time of the data collection tools is planned to be completed in approximately 20 minutes as pre-test and post-test. Before the women in the experimental group are applied with SG glasses, the Personal Information Form, State Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Scale (GCS) will be applied and pre-test data will be collected. Then, these women will watch videos with nature scenes using SG glasses during the uterine tone assessment. After the uterine tone assessment process is completed, the pregnant women in the experimental group will be applied the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Scale (GCS) again and the post-test data will be collected and the data collection process will be completed. Before the uterine tone assessment, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Scale (GCS) will be applied to the women in the control group and pre-test data will be collected. No intervention will be applied to these women during the uterine tone assessment process. After the uterine tone assessment process is completed, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and General Comfort Scale (GCS) will be applied to the pregnant women in the control group again and post-test data will be collected, and the data collection process will be completed. The pre-natal hemoglobin value and the 6th hour post-natal hemoglobin value of all women in the experimental and control groups will be recorded as part of the hospital's routine procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Literate, No communication problems, Within the first 24 hours after birth, No psychiatric diagnosis, No health problems during pregnancy.

Exclusion criteria

illiterate in intensive care after birth

Treatment and study plan

Virtual reality (VR) glasses are used as a midwifery intervention to reduce anxiety, stress, comfort and pain by drawing the individual's attention in a different direction. VR glasses are a stress in

Other

Virtual reality (VR) glasses are used as a midwifery intervention to reduce anxiety, stress, comfort and pain by drawing the individual's attention in a different direction. VR glasses are a stress induction method that provides a fictional reality simulation with visual-visual orientation and three-dimensional views that allow the person to experience real-time perspective. Women may experience pain at different levels in the postpartum period. Pain affects the woman's emotional state and severe pain can cause anxiety in the woman. Pain in the postpartum period is usually caused by rapid and intermittent contractions of the uterus. The application of pressure to the uterine fundus by the midwife to evaluate the amount of postpartum bleeding and the tone of the uterus may increase the woman's pain and anxiety level and may also cause deterioration in her general comfort. Considering this information, it is thought that the relaxing effect of using virtual glasses during the uterine ton

Primary outcomes

  1. Visual Analog Scale (VAS) scores

    Time frame: 20 minute

    The Visual Analog Scale will be used to assess the pain that will occur during the postpartum uterine tone assessment. VAS is a scale created between 0-10 cm. According to the scale, 0 cm: pain is not severe at all, 10 cm: unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.

Secondary outcomes

  1. Spielberger State Anxiety Inventory (STAI) Scores

    Time frame: 20 minute

    The inventory, which was developed by Spielberger, Gorsuch and Lushene in 1970 and whose validity and reliability in Turkish were made by Öner and Le Compte in 1985, consists of 20 items measuring state anxiety. The State Anxiety Inventory (SAI) requires the individual to describe how he/she feels at a certain moment and under certain conditions. The inventory is answered using 4-point scales. The feelings and behaviors expressed in the State Anxiety Inventory items are indicated by selecting one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the degree of severity of such experiences. There are 10 reverse items in the SAI. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The remaining items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 directly measure the expression. Two separate keys are prepared to determine the total weights of the direct and reverse items in scoring. The total weighted score obtained for the direct statements is subtracted

Other outcomes

  1. Postpartum Comfort Scale (PPSC) Scores

    Time frame: 20 minute

    The Postpartum Comfort Scale is a 5-point Likert-type scale developed by Karakaplan and Yıldız (2010) to measure comfort levels. Scoring and expressions ranging from "completely agree" (5 points) to "completely disagree" (1 point) were made for all scale items. The expression "completely agree" represents the highest comfort (5 points) in positive sentences, while it represents the lowest comfort (1 point) in negative sentences. In this case, the highest score that can be obtained from the scale is 170, and the lowest score is 34. An increase in the mean score obtained from the scale indicates that the comfort level has also increased. The Cronbach's Alpha reliability coefficient of the scale was found to be .78 for the total DSKÖ.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Acronym: Uterine Tone

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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