Use of Virtual Reality Glasses for Pain and Anxiety After Cesarean

NCT06232057 | Completed

• 1 other identifier: AmasyaÜ-Ketenedis-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Pain, Postoperative; Anxiety

Keywords

Cesarean Section; Pain; Anxiety; Virtual reality

Outcome Measures

Primary Outcomes (5)

• Preoperative anxiety level

  Preoperative anxiety level will be measured with STAI.

  Preoperatif

• Postoperative pain level-1

  The pain level at the 2nd hour after cesarean section will be measured with VAS.

  Postoperative 2nd hour

• Postoperative anxiety level

  Anxiety level after cesarean section will be measured with STAI within the first 4 hours.

  Within the first 4 hours postoperatively

• Postoperative pain level-2

  The pain level at the 4th hour after cesarean section will be measured with VAS.

  Postoperative 4th hour

• Postoperative pain level-3

  The pain level at the 6th hour after cesarean section will be measured with VAS.

  Postoperative 6th hour

Study Arms (2)

Intervention Group

EXPERIMENTAL

Virtual Reality Application Group

Other: Virtual Reality

Control Group

NO INTERVENTION

Control group without any intervention

Interventions

Virtual Reality OTHER

Women in the intervention group will be given a pre-test (STAI) before cesarean. Then, they will be shown a relaxing video (video with nature views accompanied by nature sounds) through virtual reality glasses for a maximum of 20 minutes. After a cesarean, women's anxiety levels (STAI) will be evaluated within the first 4 hours postoperatively. Pain levels (VAS) will be assessed postoperatively at the 2nd, 4th, and 6th hours.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University

Amasya, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• ELİF KETEN EDİS

  Amasya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled study will be conducted with women who had a cesarean in the Obstetrics and Gynecology clinic of a public hospital in northern Turkey.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)