Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety After Cesarean Section: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Gizem Türkmen, MSc Student
- Phone Number: 05434302033
- Email: gizemturkkmen19@gmail.com
Study Contact Backup
- Name: Nazlı Baltacı, Assoc. Prof., phD
- Phone Number: 03623121919- 6359
- Email: baltacinazli@gmail.com
Study Locations
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Samsun, Turkey (Türkiye), 55
- Gynecology and Obstetrics Department affiliated to the Gynecology and Obstetrics Department of Samsun Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Being over 18 years of ageBeing able to read and write in Turkish
- Giving birth at term, having a single, live and healthy baby
- The baby being with the mother
- Having a healthy/risk-free pregnancy
- Having had spinal anesthesia.
Exclusion Criteria:
- Having a diagnosed psychiatric disease,
- Having a mental disability and communication problem,
- Having a vision or hearing problem,
- Developing complications during or after a cesarean section,
- Having any obstacles to postpartum mobilization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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No Intervention: Control Group with Standard Care
Participants in the control group did not undergo any intervention other than routine post-caesarean care (verbal information about the procedure and brief written information about the procedure are planned to be provided).
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Experimental: Intervention Group Using Virtual Reality Glasses
The researcher informed the women in the intervention group about the study, introduced them to the virtual reality glasses after obtaining written consent, and taught them how to use the glasses.
Subsequently, the data collection form, State Anxiety Scale, and visual analogue scale rating scale for pain were administered face-to-face to both groups.
After the first mobilisation, postpartum women were shown a nature landscape video through virtual reality glasses (VRG) accompanied by nature sounds for an average of 20 minutes.
Each woman watched the same video.
Pain and anxiety were reassessed after the application.
The same application was performed for each woman, and the goggles were disinfected with Dermosept surface disinfectant, which provides cold sterilisation, prior to the application.
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Pharmacological and non-pharmacological methods are applied in the management of pain and anxiety after cesarean section (Tetik & Tekinemre, 2017).
In addition to medical treatment during the post-cesarean care process, complementary and supportive non-pharmacological approaches can be used to address the woman holistically and provide multi-faceted contributions to the health of the mother and baby (Ali, 2022; Bayraktar, 2023).
One of the non-pharmacological approaches, virtual reality glasses, is a device that provides two or three-dimensional environments to stimulate our senses by creating illusions of images (Appel et al., 2021).
SGG creates a therapeutic effect by diverting attention, provides relaxation, and can thus be used in the management of pain and anxiety (Ayed et al., 2019).
It has been determined that virtual reality glasses are an effective method in the management of pain and anxiety in the field of nursing (Akıncı & Aydın Özkan, 2024).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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State Anxiety Level
Time Frame: Anxiety levels were assessed before and after the intervention.
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State anxiety level will be measured with Spielberger State Anxiety Scale.
The Turkish reliability and validity study of the scale, which was developed by Spielberger and his colleagues to measure an individual's state and trait anxiety levels, was conducted by Öner and Le Compte in 1983.
The scale examines anxiety in two sub-dimensions: State Anxiety measures an individual's feelings under a certain moment and condition, while Trait Anxiety expresses the individual's general anxiety level.
Each statement in the scale is a 4-point Likert-type scale.
There are 20 items in both types in the Spielberger State-Trait Anxiety Scale.
The total score obtained from the scale varies between 20 and 80, with high scores indicating a high level of anxiety.
The scale does not have any cut-off value.
Cronbach's alpha coefficient was found to be 0.83 for State Anxiety.
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Anxiety levels were assessed before and after the intervention.
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Pain Level
Time Frame: Pain levels were assessed before and after the intervention.
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Pain level will be measured with Visual Analog Scale.
The use of the scale, developed by Price et al. in 1983, is achieved by measuring pain based on the statements of the people participating in the research.
It is a one-dimensional, easy-to-administer scale and is widely used.
It is a scale that the individual evaluates by making marks on a horizontal or vertical line of 10 cm or 100 mm, indicating that one end is very good and the other end is very poor.
In our study, the scale starts with "mild pain" and ends with "very severe pain".
A higher score from the scale indicates increased pain intensity.
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Pain levels were assessed before and after the intervention.
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Nazlı Baltacı, Assoc. Prof., phD, baltacinazli@gmail.com
- Principal Investigator: Gizem Türkmen, MSc Student, gizemturkkmen19@gmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- OMU-TURKMEN-2024/367
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
product manufactured in and exported from the U.S.
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