Obstetrics and GynaecologyNCT06668428
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section
A study testing Virtual Reality Glasses in people with Obstetrics and Gynaecology and Nursing, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetrics and Gynaecology, Nursing, Caesarean Section
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2024to 15 Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gynecology and Obstetrics Department affiliated to the Gynecology and Obstetrics Department of Samsun Education and Research Hospital
Samsun, 55
About this study
Official title: 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.
- Conditions
- Obstetrics and Gynaecology, Nursing, Caesarean Section, Pain, Anxiety
- Being tested
- Virtual Reality Glasses
- Keywords
- Pain, Anxiety, Caesarean Section, Nurse, Virtual Reality, Nature Sounds
- 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 GlassesDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group with Standard Care | No intervention | 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). |
| Intervention Group Using Virtual Reality Glasses | Experimental | 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. Receives: Device: Virtual Reality Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level
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.
Measured: Anxiety levels were assessed before and after the intervention.
Pain Level
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.
Measured: Pain levels were assessed before and after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start24 Dec 2024
- Primary completion17 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrics and GynaecologyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Parallel groups
- Model description
- The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Baltacı, Ondokuz Mayıs University
- Investigators
- Nazlı Baltacı, Assoc. Prof., phD, Study director, baltacinazli@gmail.comGizem Türkmen, MSc Student, Principal investigator, gizemturkkmen19@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668428
- Sponsor's protocol ID
- OMU-TURKMEN-2024/367
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The data collected for this study will be used solely for the purposes of the present research. Only aggregated results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality and Nature Sounds on Pain and Anxiety After Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06668428
- Acronym / sponsor ID
- OMU-TURKMEN-2024/367
- Conditions
- Obstetrics and Gynaecology, Nursing, Caesarean Section, Pain, Anxiety
- Keywords
- Pain, Anxiety, Caesarean Section, Nurse, Virtual Reality, Nature Sounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 31 Oct 2024 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Control Group with Standard Care | No intervention | –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). |
| Intervention Group Using Virtual Reality Glasses | Experimental | Device: Virtual Reality GlassesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 GlassesPharmacological 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). | Device | Intervention Group Using Virtual Reality Glasses |
Primary outcome
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.
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.
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The data collected for this study will be used solely for the purposes of the present research. Only aggregated results will be reported.
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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.
Nazlı Baltacı, Assoc. Prof., phD study director
baltacinazli@gmail.com
Gizem Türkmen, MSc Student principal investigator
gizemturkkmen19@gmail.com
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 Glasses in people with Obstetrics and Gynaecology and Nursing, run by Ondokuz Mayıs 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 6 inclusion and 5 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 14 Sep 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?
State Anxiety Level (time frame: Anxiety levels were assessed before and after the intervention.). The study lists 2 primary outcomes in all. 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 14 Sep 2026.