he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort
April 11, 2026 updated by: Sakarya University
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
105
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
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Kocaeli, Turkey (Türkiye), 41100
- Kocaeli State Hospital
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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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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. |
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Experimental: Experimental Group (Comfort Theory Based Care
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. |
In the research, this group includes care-based intervention
|
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Experimental: Experimental Group (Virtual Reality Glasses)
The experimental group will be intervened with virtual reality glasses.
|
In the research, this group includes interventions with virtual reality glasses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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postpartum first day, postpartum second day, postpartum third day
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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).
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postpartum first day, postpartum second day, postpartum third day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ayşe Çevirme, acevirme@sakarya.edu.tr
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- 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.
- Karakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.
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)
February 1, 2025
Primary Completion (Actual)
September 1, 2025
Study Completion (Actual)
January 29, 2026
Study Registration Dates
First Submitted
September 3, 2024
First Submitted That Met QC Criteria
February 28, 2025
First Posted (Actual)
March 3, 2025
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 11, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-71522473-050.04-363990-135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.