Use of Virtual Reality Glasses for Pain and Anxiety After Cesarean

Amasya University

Status: Enrolling

Conditions: Cesarean Section; Pain, Postoperative; Anxiety

Treatments: Other: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06232057

AmasyaÜ-Ketenedis-001

Details and patient eligibility

About

The goal of this randomized controlled trial is to examine the effect of preoperative virtual reality used before cesarean on postoperative pain and anxiety. The main question[s] it aims to answer are:

• What is the anxiety level of women in the intervention and control groups after using virtual reality?
• What is the pain level of women in the intervention and control groups after using virtual reality?

Women in the intervention group will be shown a relaxing video accompanied by virtual reality glasses before cesarean. No intervention will be applied to women in the control group. Researchers will compare pre- and post-operative anxiety levels and post-operative pain levels of both groups.

Full description

Cesarean is a major surgical operation that is widely performed around the world. Pain after cesarean is more significant than expected, and pain control remains a problem. In addition, the women undergoing cesarean experience stress and anxiety due to the surgical process. Anxiety and pain experienced after cesarean affect the mother physiologically and psychologically, negatively affecting the healing process. Therefore, it is essential to determine interventions that will reduce pain and anxiety in women undergoing cesarean. This study aims to examine the effect of preoperative virtual reality use on postoperative pain and anxiety in women undergoing cesarean.

This study has a randomized controlled experimental design. The research will be carried out in the Obstetrics and Gynecology Clinic of a public hospital in the North of Turkey. Women who had a cesarean will be included in the study. Participants will be randomly assigned to the intervention or control group using a computer-generated list. A data collection form including an Introductory information form including sociodemographic and obstetric characteristics, Spielberger State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) will used for each participant. After obtaining written informed consent, the anxiety levels of women in the intervention and control groups will be determined by applying a pre-test (STAI). Then, the women in the intervention group will be shown a relaxing video (video with a nature view accompanied by nature sounds) through preoperative virtual reality glasses. No intervention will be applied to women in the control group. After surgery, the anxiety levels of women in both groups will be evaluated in the first 4 hours, and the pain levels will be evaluated in the 2nd, 4th, and 6th hours. The IBM SPSS (Statistical Package for the Social Sciences) 21.0 package program will be used to evaluate the data obtained in the study.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and over
• Communicate in Turkish
• Must have cesarean with spinal anesthesia
• Must have cesarean after the 37th week of pregnancy
• Must have a planned cesarean

Exclusion criteria

• Under 18 years
• Not being able to speak Turkish
• Vision and hearing problem
• Cesarean section with general anesthesia
• Emergency cesarean

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Virtual Reality Application Group

Treatment:

Other: Virtual Reality

Control Group

No Intervention group

Description:

Control group without any intervention