- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06668428
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section
July 29, 2025 updated by: Nazlı Baltacı, Ondokuz Mayıs University
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety After Cesarean Section: A Randomized Controlled Trial
This study was conducted to determine the effects of virtual reality application on pain and anxiety in women who gave birth by caesarean section.
It was applied to women who had given birth by caesarean section at a public hospital in northern Turkey, voluntarily agreed to participate in the study, and were randomly assigned to the intervention (n=40) and control (n=40) groups.
Women in the intervention group were taught how to use virtual reality goggles.
After the first mobilisation, women were shown a nature landscape video through virtual reality goggles (VRG) accompanied by nature sounds for an average of 20 minutes.
The aim of this application was to enable women to view nature images more effectively accompanied by nature sounds, thereby helping them to focus on the images and sounds, distract their attention, relax, and escape the tension of their surroundings.
The application was carried out with the women in a semi-reclining position and without sleeping.
The same application was applied to each woman, and the glasses were disinfected with Dermosept surface disinfectant, which provides cold sterilisation, before the application.
No application was made to the women in the control group; only the hospital's routine care was applied.
The data were collected by the researcher through face-to-face interviews based on the statements of women after caesarean section.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Samsun, Turkey, 55
- Gynecology and Obstetrics Department affiliated to the Gynecology and Obstetrics Department of Samsun Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
|
|
Experimental: Control 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Level
Time Frame: Anxiety levels were assessed before and after the intervention.
|
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.
|
Anxiety levels were assessed before and after the intervention.
|
|
Pain Level
Time Frame: Pain levels were assessed before and after the intervention.
|
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.
|
Pain levels were assessed before and after the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nazlı Baltacı, Assoc. Prof., phD, baltacinazli@gmail.com
- Principal Investigator: Gizem Türkmen, MSc Student, gizemturkkmen19@gmail.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 24, 2024
Primary Completion (Actual)
March 17, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
October 30, 2024
First Submitted That Met QC Criteria
October 30, 2024
First Posted (Actual)
October 31, 2024
Study Record Updates
Last Update Posted (Actual)
August 1, 2025
Last Update Submitted That Met QC Criteria
July 29, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMU-TURKMEN-2024/367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
You are undertaking that your answers to the questions will be kept confidential and will not be shared with anyone.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on Virtual Reality Glasses
-
Cihat OzyılmazCompletedChild | Anxiety | FearTurkey
-
Yuzuncu Yil UniversityCompletedHyperthyroidism | Virtual RealityTurkey (Türkiye)
-
Ankara Yildirim Beyazıt UniversityCompletedVirtual Reality | Education | Bariatric Surgery | NursingTurkey (Türkiye)
-
Biruni UniversityCompleted
-
Saglik Bilimleri UniversitesiCompletedPain | Anxiety | Gastro-Intestinal DisorderTurkey
-
Necmettin Erbakan UniversityHealth Institutes of TurkeyCompleted
-
Özlem ÇiçekIzmir Bakircay UniversityCompletedEpisiotomy WoundTurkey
-
Istanbul Sabahattin Zaim UniversityCompleted
-
Esra DOĞAN YILMAZ, RN, MScCompletedThe Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing ColonoscopyAnxiety | Colonoscopy | Vital SignsTurkey
-
Saglik Bilimleri UniversitesiUnknown