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NCT Number: NCT06680141

The Effect of Virtual Reality Glasses Used Before Cesarean Section

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sümeyye BAL, Ph.D.

CONTACT

0(362)3121919 ext. 6424

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Virtual reality glasses

Other

control group

Other names: control group

Primary outcomes

  1. 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.

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Sümeyye BAL, Ph.D

CONTACT

[email protected]

05434276696

Sümeyye BAL, Ph.D.

CONTACT

[email protected]

05434276696

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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