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Clinical Trials/NCT06680141
NCT06680141
Recruiting
Not Applicable

The Effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

Ondokuz Mayıs University1 site in 1 country120 target enrollmentNovember 1, 2024
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Ondokuz Mayıs University
Enrollment
120
Locations
1
Primary Endpoint
Spielberger State Anxiety Scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

Detailed Description

Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group. The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups. Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied. control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Sümeyye BAL

Director

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Will undergo a cesarean section for the first time,
  • Are over the age of 18,
  • Have no diagnosed mental illness,
  • Have no diagnosed physical illness in themselves or their baby,
  • Volunteer to participate in the study

Exclusion Criteria

  • Have previously undergone a cesarean section,
  • Are under the age of 18,
  • Have a diagnosed mental illness,
  • Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -

Outcomes

Primary Outcomes

Spielberger State Anxiety Scale

Time Frame: 30 minutes

The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87. It will be applied half an hour before the surgery.

Surgical Fear Scale (SFS):

Time Frame: 30 minutes

The scale was developed by Theunissen et al. (2014) and its validity and reliability for use in Turkey were established by Bağdigen and Karaman Özlü (2018). The scale consists of 8 items in an 11-point Likert format, scored between 0 and 10. It is divided into two subscales, each containing 4 items, measuring short-term and long-term fears related to surgery. Items 1-4 assess fear regarding short-term outcomes of surgery, while items 5-8 evaluate fear concerning long-term outcomes. Each item is rated from "0: not afraid at all" to "10: extremely afraid." A higher total score, with a maximum of 26 points, indicates a greater level of fear. In the validity and reliability study, the Cronbach's alpha coefficient for the total score was found to be 0.93.It will be applied half an hour before the surgery.

Study Sites (1)

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