Clinical trial NCT06232057: Use of Virtual Reality Glasses for Pain and Anxiety After Cesarean
Official title: The Effect of Preoperative Virtual Reality Glasses Use on Postoperative Pain and Anxiety in Women Having a Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Pain, Postoperative
Anxiety
Keywords: Cesarean Section
Pain
Anxiety
Virtual reality
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Preoperative anxiety level
timeFrame: Preoperatif
measure: Postoperative pain level-1
timeFrame: Postoperative 2nd hour
measure: Postoperative anxiety level
timeFrame: Within the first 4 hours postoperatively
measure: Postoperative pain level-2
timeFrame: Postoperative 4th hour
measure: Postoperative pain level-3
timeFrame: Postoperative 6th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
affiliation: Amasya University
name: ELİF KETEN EDİS
role: STUDY_DIRECTOR
References: