Pregnancy RelatedUterine ToneNCT07545863
Effect of Using Virtual Glasses on Anxiety, Pain and Comfort During Uterine Tonus Assessment
A study testing 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 in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate, No communication problems, Within the first 24 hours after birth, No psychiatric diagnosis, No health problems during pregnancy.
Who cannot join
- illiterate in intensive care after birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University
Malatya, None Selected, 44000
About this study
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.
Read the detailed description
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.
- Conditions
- Pregnancy Related
- Being tested
- 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
- Keywords
- uterus, tone, virtual reality, puerperium, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 inOther
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
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | group without virtual glasses |
| virtual glasses applied group | Experimental | virtual glasses applied group Receives: 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 in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) scores
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.
Measured: 20 minute
Secondary outcomes (1)
Spielberger State Anxiety Inventory (STAI) Scores
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
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevhibe Coban, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545863
- Sponsor's protocol ID
- 2023/5359
- Acronym
- Uterine Tone
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Virtual Glasses on Anxiety, Pain and Comfort During Uterine Tonus Assessment
- ClinicalTrials.gov ID
- NCT07545863
- Acronym / sponsor ID
- Uterine Tone / 2023/5359
- Conditions
- Pregnancy Related
- Keywords
- uterus, tone, virtual reality, puerperium, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –group without virtual glasses |
| virtual glasses applied group | Experimental | 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 invirtual glasses applied group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Literate, No communication problems, Within the first 24 hours after birth, No psychiatric diagnosis, No health problems during pregnancy.
Key exclusion criteria (1 listed)
- illiterate in intensive care after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 inVirtual 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 | Other | virtual glasses applied group |
Primary outcome
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.
1 secondary outcome
Spielberger State Anxiety Inventory (STAI) Scores
Time frame: 20 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- https://pubmed.ncbi.nlm.nih.gov/31003667/Link provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Pregnancy Related, run by Inonu University 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 1 inclusion and 1 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 22 Apr 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?
Visual Analog Scale (VAS) scores (time frame: 20 minute). 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 22 Apr 2026.