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

NCT06853821 | Completed

• 1 other identifier: E-71522473-050.04-363990-135
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Care

Keywords

Postpartum Period; Pain; Comfort Care; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  postpartum first day, postpartum second day, postpartum third day

Study Arms (3)

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.

Other: Comfort Theory Based Care

Experimental Group (Virtual Reality Glasses)

EXPERIMENTAL

The experimental group will be intervened with virtual reality glasses.

Other: Virtual Reality Glasses

Interventions

Comfort Theory Based Care OTHER

In the research, this group includes care-based intervention

Experimental Group (Comfort Theory Based Care

Virtual Reality Glasses OTHER

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

Experimental Group (Virtual Reality Glasses)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Kocaeli State Hospital

Kocaeli, 41100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 7930099 BACKGROUND

• Karakaplan, S. ve Yıldız, H. (2010). Doğum Sonu Konfor Ölçeği geliştirme çalışması. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 3(1),55-65.

  BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Çevirme

  acevirme@sakarya.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were assigned to groups using the "simple randomization" method. Participants were not informed about which group they were in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: March 3, 2025
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: January 29, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)