NCT07545863

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

uterustonevirtual realitypuerperiumpainanxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minute

Secondary Outcomes (1)

  • Spielberger State Anxiety Inventory (STAI) Scores

    20 minute

Other Outcomes (1)

  • Postpartum Comfort Scale (PPSC) Scores

    20 minute

Study Arms (2)

standard care

NO INTERVENTION

group without virtual glasses

virtual glasses applied group

EXPERIMENTAL

virtual glasses applied group

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

Interventions

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

virtual glasses applied group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • illiterate in intensive care after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, None Selected, 44000, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant)
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

April 22, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Research results will be shared.

Locations