- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545863
Effect of Using Virtual Glasses on Anxiety, Pain and Comfort During Uterine Tonus Assessment (Uterine Tone)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
None Selected
-
Malatya, None Selected, Turkey (Türkiye), 44000
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: standard care
group without virtual glasses
|
|
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Experimental: virtual glasses applied group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
20 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 minute
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/5359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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