The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous

NCT06336421 | Completed

• 1 other identifier: Şuletuvanç
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room.

Conditions

Cesarean Section Complications

Keywords

Virtual Reality; Cesarean; Primiparous; Anxiety; Vital Signs

Outcome Measures

Primary Outcomes (3)

• Personal Information Form

  There are 18 questions in this form, prepared by the researchers in line with the literature.

  8 months

• State Anxiety Scale

  This scale was developed by Spielberger et al. Developed by. The adaptation of the scale to Turkish and its validity and reliability studies were carried out by Öner and Le Compte in 1983.The scale is a 4-point Likert scale consisting of the options "not at all", "somewhat", "a lot", "completely". There are 10 direct and 10 reversed statements in the scale. Positive (increasing the total anxiety score) for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18 in the scale; 1, 2, 5, 8, 10, 11, 15, 16, 19 Negative scores (reducing the total anxiety score) are obtained for the 20th items. The highest score is 80 and the lowest score is 20. A high total score indicates that the person's anxiety level is also high.Cronbach's alpha coefficient was found to be 0.79 for state anxiety. In this study, Cronbach's Alpha value was found to be 0.83.

  8 months

• Pregnant follow-up form

  Blood pressure, pulse, respiration and the amount of oxygen in the blood were measured before and after the procedure and recorded on this form.

  8 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. The video, in which baby pictures will be shown accompanied by virtual reality music, was prepared by the researcher and a faculty member in the music department. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.

Other: Virtual Reality

Control group

NO INTERVENTION

* Written consent was obtained from pregnant women who agreed to participate in the study. * 10 minutes before cesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women. * The pregnant woman's anxiety level before the procedure was determined using the State Anxiety Scale. * Before the procedure, blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded. * Routine practice was performed during cesarean section. * 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed.

Interventions

Virtual Reality OTHER

VR Box brand virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having undergone epidural anesthesia, spinal anesthesia, combined anesthesia,
• Not having an emergency cesarean section,
• Being over 18 years of age,
• Being at least a primary school graduate,
• Not having been diagnosed with a high-risk pregnancy,
• Agreeing to participate in the research voluntarily,
• Not having any hearing or vision problems (for the experimental group),
• Not taking medications that affect blood pressure and pulse rate (such as digoxin, adrenaline, dopamine),
• No diagnosed psychiatric disease,
• Being primiparous,
• Being between 38-40 weeks of pregnancy.

You may not qualify if:

• Leaving the study at any stage of the research
• Patients who need general anesthesia during surgery.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ayse Aydin

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ayşe Aydın

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistics expert
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: November 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: March 22, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)