The Effect of Virtual Reality Glasses Used Before Cesarean Section

NCT06680141 | Recruiting

• 1 other identifier: 2022/260
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• Spielberger State Anxiety Scale

  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.

  30 minutes

• Surgical Fear Scale (SFS):

  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.

  30 minutes

Study Arms (2)

Virtual Reality Glasses

EXPERIMENTAL

Among the women who have been admitted for a planned caesarean section, the Informed Consent Form and the Data Collection Form including Sociodemographic Characteristics, Surgical Fear Scale, Spielberg State-Trait Anxiety Scale will be applied to the women who meet the criteria and randomization will be applied. After randomization, they will be divided into a virtual reality glasses application group and a control group. All women will be applied the Spielberg State-Trait Anxiety Scale and Surgical Fear Scale in the patient room before and after the SGG application. The experimental group will be shown a video (30 minutes) of the 9-month fetal development process, with glasses on before going to surgery.

Other: Virtual reality glasses

control

NO INTERVENTION

Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform

Interventions

Virtual reality glasses OTHER

control group

Also known as: control group

Virtual Reality Glasses

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Emine KOÇ, Asst.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

• Nazlı Baltacı, Asst.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

Central Study Contacts

Sümeyye BAL, Ph.D

CONTACT

05434276696; sumeyyebal@gmail.com

Sümeyye BAL, Ph.D.

CONTACT

05434276696; sumeyyebal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: November 8, 2024
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-11

Locations

TU (1)