The Effect of Virtual Reality Glasses Used Before Cesarean Section

NCT ID: NCT06680141

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual reality glasses

Intervention Type OTHER

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality glasses

control group

Intervention Type OTHER

Other Intervention Names

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control group

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Sümeyye BAL

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine KOÇ, Asst.Prof

Role: STUDY_CHAIR

Ondokuz Mayıs University

Nazlı Baltacı, Asst.Prof

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

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Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sümeyye BAL, Ph.D

Role: CONTACT

05434276696

Sümeyye BAL, Ph.D.

Role: CONTACT

05434276696

Facility Contacts

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Sümeyye BAL, Ph.D.

Role: primary

0(362)3121919 ext. 6424

Other Identifiers

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2022/260

Identifier Type: -

Identifier Source: org_study_id

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