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he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06853821
Enrollment
105
Registered
2025-03-03
Start date
2025-02-01
Completion date
2026-01-29
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care

Keywords

Postpartum Period, Pain, Comfort Care, Virtual Reality

Brief 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. 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.

Interventions

OTHERComfort Theory Based Care

In the research, this group includes care-based intervention

OTHERVirtual Reality Glasses

In the research, this group includes interventions with virtual reality glasses.

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants were assigned to groups using the "simple randomization" method. Participants were not informed about which group they were in.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postpartum Comfort Scalepostpartum first day, postpartum second day, postpartum third dayIt 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 Scalepostpartum first day, postpartum second day, postpartum third dayIt is used to evaluate pain severity. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain) (Huskisson, 1974).

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORAyşe Çevirme

acevirme@sakarya.edu.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026