The Effect of Virtual Reality Glasses Used Before Cesarean Section

January 20, 2025 updated by: Sümeyye BAL, Ondokuz Mayıs University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Samsun, Turkey, 55200
        • Recruiting
        • Ondokuz Mayis University
        • Contact:
          • Sümeyye BAL, Ph.D.
          • Phone Number: 6424 0(362)3121919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Glasses
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 group
Other Names:
  • control group
No Intervention: control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Chair: Emine KOÇ, Asst.Prof, Ondokuz Mayıs University
  • Study Chair: Nazlı Baltacı, Asst.Prof, Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/260

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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