Cesarean SectionNCT06232057
Use of Virtual Reality Glasses for Pain and Anxiety After Cesarean
A study testing Virtual Reality in people with Cesarean Section and Pain, Postoperative, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial is to examine the effect of preoperative virtual reality used before cesarean on postoperative pain and anxiety. The main question[s] it aims to answer are: What is the anxiety level of women in the intervention and control groups after using virtual reality? What is the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section, Pain, Postoperative, Anxiety
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 10 Jul 2024
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years and over
- Communicate in Turkish
- Must have cesarean with spinal anesthesia
- Must have cesarean after the 37th week of pregnancy
- Must have a planned cesarean
Who cannot join
- Under 18 years
- Not being able to speak Turkish
- Vision and hearing problem
- Cesarean section with general anesthesia
- Emergency cesarean
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Virtual Reality Glasses Use on Postoperative Pain and Anxiety in Women Having a Caesarean Section
The goal of this randomized controlled trial is to examine the effect of preoperative virtual reality used before cesarean on postoperative pain and anxiety. The main question[s] it aims to answer are:
- What is the anxiety level of women in the intervention and control groups after using virtual reality?
- What is the pain level of women in the intervention and control groups after using virtual reality?
Women in the intervention group will be shown a relaxing video accompanied by virtual reality glasses before cesarean. No intervention will be applied to women in the control group. Researchers will compare pre- and post-operative anxiety levels and post-operative pain levels of both groups.
Read the detailed description
Cesarean is a major surgical operation that is widely performed around the world. Pain after cesarean is more significant than expected, and pain control remains a problem. In addition, the women undergoing cesarean experience stress and anxiety due to the surgical process. Anxiety and pain experienced after cesarean affect the mother physiologically and psychologically, negatively affecting the healing process. Therefore, it is essential to determine interventions that will reduce pain and anxiety in women undergoing cesarean. This study aims to examine the effect of preoperative virtual reality use on postoperative pain and anxiety in women undergoing cesarean.
This study has a randomized controlled experimental design. The research will be carried out in the Obstetrics and Gynecology Clinic of a public hospital in the North of Turkey. Women who had a cesarean will be included in the study. Participants will be randomly assigned to the intervention or control group using a computer-generated list. A data collection form including an Introductory information form including sociodemographic and obstetric characteristics, Spielberger State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) will used for each participant. After obtaining written informed consent, the anxiety levels of women in the intervention and control groups will be determined by applying a pre-test (STAI). Then, the women in the intervention group will be shown a relaxing video (video with a nature view accompanied by nature sounds) through preoperative virtual reality glasses. No intervention will be applied to women in the control group. After surgery, the anxiety levels of women in both groups will be evaluated in the first 4 hours, and the pain levels will be evaluated in the 2nd, 4th, and 6th hours. The IBM SPSS (Statistical Package for the Social Sciences) 21.0 package program will be used to evaluate the data obtained in the study.
- Conditions
- Cesarean Section, Pain, Postoperative, Anxiety
- Being tested
- Virtual Reality
- Keywords
- Cesarean Section, Pain, Anxiety, Virtual reality
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Women in the intervention group will be given a pre-test (STAI) before cesarean. Then, they will be shown a relaxing video (video with nature views accompanied by nature sounds) through virtual reality glasses for a maximum of 20 minutes. After a cesarean, women's anxiety levels (STAI) will be evaluated within the first 4 hours postoperatively. Pain levels (VAS) will be assessed postoperatively at the 2nd, 4th, and 6th hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Virtual Reality Application Group Receives: Other: Virtual Reality |
| Control Group | No intervention | Control group without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety level
Preoperative anxiety level will be measured with STAI.
Measured: Preoperatif
Postoperative pain level-1
The pain level at the 2nd hour after cesarean section will be measured with VAS.
Measured: Postoperative 2nd hour
Postoperative anxiety level
Anxiety level after cesarean section will be measured with STAI within the first 4 hours.
Measured: Within the first 4 hours postoperatively
Postoperative pain level-2
The pain level at the 4th hour after cesarean section will be measured with VAS.
Measured: Postoperative 4th hour
Postoperative pain level-3
The pain level at the 6th hour after cesarean section will be measured with VAS.
Measured: Postoperative 6th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- This randomized controlled study will be conducted with women who had a cesarean in the Obstetrics and Gynecology clinic of a public hospital in northern Turkey.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ELİF KETEN EDİS, Study director, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232057
- Sponsor's protocol ID
- AmasyaÜ-Ketenedis-001
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Virtual Reality Glasses Use on Postoperative Pain and Anxiety in Women Having a Caesarean Section
- ClinicalTrials.gov ID
- NCT06232057
- Acronym / sponsor ID
- AmasyaÜ-Ketenedis-001
- Conditions
- Cesarean Section, Pain, Postoperative, Anxiety
- Keywords
- Cesarean Section, Pain, Anxiety, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 30 Jan 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.
The goal of this randomized controlled trial is to examine the effect of preoperative virtual reality used before cesarean on postoperative pain and anxiety. The main question[s] it aims to answer are:
- What is the anxiety level of women in the intervention and control groups after using virtual reality?
- What is the pain level of women in the intervention and control groups after using virtual reality?
Women in the intervention group will be shown a relaxing video accompanied by virtual reality glasses before cesarean. No intervention will be applied to women in the control group. Researchers will compare pre- and post-operative anxiety levels and post-operative pain levels of both groups.
Detailed description
Cesarean is a major surgical operation that is widely performed around the world. Pain after cesarean is more significant than expected, and pain control remains a problem. In addition, the women undergoing cesarean experience stress and anxiety due to the surgical process. Anxiety and pain experienced after cesarean affect the mother physiologically and psychologically, negatively affecting the healing process. Therefore, it is essential to determine interventions that will reduce pain and anxiety in women undergoing cesarean. This study aims to examine the effect of preoperative virtual reality use on postoperative pain and anxiety in women undergoing cesarean.
This study has a randomized controlled experimental design. The research will be carried out in the Obstetrics and Gynecology Clinic of a public hospital in the North of Turkey. Women who had a cesarean will be included in the study. Participants will be randomly assigned to the intervention or control group using a computer-generated list. A data collection form including an Introductory information form including sociodemographic and obstetric characteristics, Spielberger State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) will used for each participant. After obtaining written informed consent, the anxiety levels of women in the intervention and control groups will be determined by applying a pre-test (STAI). Then, the women in the intervention group will be shown a relaxing video (video with a nature view accompanied by nature sounds) through preoperative virtual reality glasses. No intervention will be applied to women in the control group. After surgery, the anxiety levels of women in both groups will be evaluated in the first 4 hours, and the pain levels will be evaluated in the 2nd, 4th, and 6th hours. The IBM SPSS (Statistical Package for the Social Sciences) 21.0 package program will be used to evaluate the data obtained in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled study will be conducted with women who had a cesarean in the Obstetrics and Gynecology clinic of a public hospital in northern Turkey.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Virtual RealityVirtual Reality Application Group |
| Control Group | No intervention | –Control group without any intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years and over
- Communicate in Turkish
- Must have cesarean with spinal anesthesia
- Must have cesarean after the 37th week of pregnancy
- Must have a planned cesarean
Key exclusion criteria (5 listed)
- Under 18 years
- Not being able to speak Turkish
- Vision and hearing problem
- Cesarean section with general anesthesia
- Emergency cesarean
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 RealityWomen in the intervention group will be given a pre-test (STAI) before cesarean. Then, they will be shown a relaxing video (video with nature views accompanied by nature sounds) through virtual reality glasses for a maximum of 20 minutes. After a cesarean, women's anxiety levels (STAI) will be evaluated within the first 4 hours postoperatively. Pain levels (VAS) will be assessed postoperatively at the 2nd, 4th, and 6th hours. | Other | Intervention Group |
Primary outcome
Preoperative anxiety level
Time frame: Preoperatif
Preoperative anxiety level will be measured with STAI.
Postoperative pain level-1
Time frame: Postoperative 2nd hour
The pain level at the 2nd hour after cesarean section will be measured with VAS.
Postoperative anxiety level
Time frame: Within the first 4 hours postoperatively
Anxiety level after cesarean section will be measured with STAI within the first 4 hours.
Postoperative pain level-2
Time frame: Postoperative 4th hour
The pain level at the 4th hour after cesarean section will be measured with VAS.
Postoperative pain level-3
Time frame: Postoperative 6th hour
The pain level at the 6th hour after cesarean section will be measured with VAS.
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
ELİF KETEN EDİS study director
Amasya University
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 in people with Cesarean Section and Pain, Postoperative, run by Amasya 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 5 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 18 Oct 2024. 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?
Preoperative anxiety level (time frame: Preoperatif). The study lists 5 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 18 Oct 2024.