CareNCT06853821
he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort
A study testing Comfort Theory Based Care and Virtual Reality Glasses in people with Care, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Care
- What is being tested?
- Comfort Theory Based Care and Virtual Reality Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 29 Jan 2026
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in research
- Having given birth with epidural anesthesia
- Being between the ages of 18-35
- Having given birth within 37-41 weeks of pregnancy
- Having a primiparous cesarean birth
Who cannot join
- Having a normal birth
- Having given birth with general anesthesia
- Having a disability that limits vision, hearing or communication
- Having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Comfort Theory-Based Care and the Use of Virtual Reality Glasses on Pain and Comfort in the Postpartum Period: Randomized Controlled Study
The research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. The hypotheses of the study are:
H0: Comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period.
Read more
H1-1: Comfort theory-based care has an effect on pain level in the postpartum period.
H1-2: Comfort theory-based care has an effect on comfort in the postpartum period.
H2-1: The use of virtual reality glasses in the postpartum period has an effect on the level of pain.
H2-2: The use of virtual reality glasses in the postpartum period has an effect on comfort.
Read the detailed description
Although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. In our country, as in many other countries, cesarean delivery rates are quite high.Pain in cesarean births is more severe and lasts longer than in vaginal birth. Along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.In the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving Kolcaba's Comfort Theory-based care to the other. Personal Information Form, Postpartum Comfort Scale, Visual Analogue Scale (VAS) and Virtual Reality Glasses Form will be used as measurement tools.This study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.Increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.
- Conditions
- Care
- Being tested
- Comfort Theory Based Care, Virtual Reality Glasses
- Keywords
- Postpartum Period, Pain, Comfort Care, Virtual Reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Theory Based CareOther
In the research, this group includes care-based intervention
Virtual Reality GlassesOther
In the research, this group includes interventions with virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be given to the control group. Pre-Post Test: A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals. |
| Experimental Group (Comfort Theory Based Care | Experimental | The experimental group will be intervened by providing comfort theory-based care.
Pre-Post Test:
A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals. Receives: Other: Comfort Theory Based Care |
| Experimental Group (Virtual Reality Glasses) | Experimental | The experimental group will be intervened with virtual reality glasses. Receives: Other: Virtual Reality Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Comfort Scale
It is a 5-point Likert type scale consisting of 34 items developed by Katharine Kolcaba (1994). Cronbach's Alpha number of the scale was determined as 0.78. The minimum score from the scale is 34 and the maximum score is 170. As the score increases, comfort increases.
Measured: postpartum first day, postpartum second day, postpartum third day
Visual Analog Scale
It is used to evaluate pain severity. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain) (Huskisson, 1974).
Measured: postpartum first day, postpartum second day, postpartum third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Sep 2025
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CareStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşe Çevirme, Study director, acevirme@sakarya.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853821
- Sponsor's protocol ID
- E-71522473-050.04-363990-135
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994 Jun;19(6):1178-84. doi: 10.1111/j.1365-2648.1994.tb01202.x.
PubMed 7930099Karakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Comfort Theory-Based Care and the Use of Virtual Reality Glasses on Pain and Comfort in the Postpartum Period: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06853821
- Acronym / sponsor ID
- E-71522473-050.04-363990-135
- Conditions
- Care
- Keywords
- Postpartum Period, Pain, Comfort Care, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 3 Mar 2025 (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 research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. The hypotheses of the study are:
H0: Comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period.
H1-1: Comfort theory-based care has an effect on pain level in the postpartum period.
H1-2: Comfort theory-based care has an effect on comfort in the postpartum period.
H2-1: The use of virtual reality glasses in the postpartum period has an effect on the level of pain.
H2-2: The use of virtual reality glasses in the postpartum period has an effect on comfort.
Detailed description
Although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. In our country, as in many other countries, cesarean delivery rates are quite high.Pain in cesarean births is more severe and lasts longer than in vaginal birth. Along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.In the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving Kolcaba's Comfort Theory-based care to the other. Personal Information Form, Postpartum Comfort Scale, Visual Analogue Scale (VAS) and Virtual Reality Glasses Form will be used as measurement tools.This study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.Increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be given to the control group. Pre-Post Test: A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals. |
| Experimental Group (Comfort Theory Based Care | Experimental | Other: Comfort Theory Based CareThe experimental group will be intervened by providing comfort theory-based care. Pre-Post Test: A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals. |
| Experimental Group (Virtual Reality Glasses) | Experimental | Other: Virtual Reality GlassesThe experimental group will be intervened with virtual reality glasses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to participate in research
- Having given birth with epidural anesthesia
- Being between the ages of 18-35
- Having given birth within 37-41 weeks of pregnancy
- Having a primiparous cesarean birth
Key exclusion criteria (4 listed)
- Having a normal birth
- Having given birth with general anesthesia
- Having a disability that limits vision, hearing or communication
- Having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding
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 |
|---|---|---|
| Comfort Theory Based CareIn the research, this group includes care-based intervention | Other | Experimental Group (Comfort Theory Based Care |
| Virtual Reality GlassesIn the research, this group includes interventions with virtual reality glasses. | Other | Experimental Group (Virtual Reality Glasses) |
Primary outcome
Postpartum Comfort Scale
Time frame: postpartum first day, postpartum second day, postpartum third day
It is a 5-point Likert type scale consisting of 34 items developed by Katharine Kolcaba (1994). Cronbach's Alpha number of the scale was determined as 0.78. The minimum score from the scale is 34 and the maximum score is 170. As the score increases, comfort increases.
Visual Analog Scale
Time frame: postpartum first day, postpartum second day, postpartum third day
It is used to evaluate pain severity. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain) (Huskisson, 1974).
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 Apr 2026.
- Background: PubMed 7930099Kolcaba KY. A theory of holistic comfort for nursing. J Adv Nurs. 1994 Jun;19(6):1178-84. doi: 10.1111/j.1365-2648.1994.tb01202.x.
- BackgroundKarakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- 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.
Ayşe Çevirme study director
acevirme@sakarya.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Theory Based Care and Virtual Reality Glasses in people with Care, run by Sakarya 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 4 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 Apr 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?
Postpartum Comfort Scale (time frame: postpartum first day, postpartum second day, postpartum third day). 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?
On the ClinicalTrials.gov record for NCT06853821, which also lists 3 linked publications.
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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.