Clinical trial NCT06853821: he Effect of Care and the Use of Virtual Reality Glasses on Pain and Comfort
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Care
Keywords: Postpartum Period
Pain
Comfort Care
Virtual Reality
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum Comfort Scale
timeFrame: postpartum first day, postpartum second day, postpartum third day
measure: Visual Analog Scale
timeFrame: postpartum first day, postpartum second day, postpartum third day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: acevirme@sakarya.edu.tr
name: Ayşe Çevirme
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Karakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.