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Completed

NCT Number: NCT06853821

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

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.

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Key information

Conditions

Care Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli State Hospital

Kocaeli, 41100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comfort Theory Based Care

Other

In the research, this group includes care-based intervention

Virtual reality glasses

Other

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

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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