Clinical trial NCT06668428: Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section
Official title: Effects of Virtual Reality and Nature Sounds on Pain and Anxiety After Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstetrics and Gynaecology
Nursing
Caesarean Section
Pain
Anxiety
Keywords: Pain
Anxiety
Caesarean Section
Nurse
Virtual Reality
Nature Sounds
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to determine the effects of virtual reality application on pain and anxiety in postpartum women after cesarean section. It will be applied to women who have had a cesarean section and who volunteered to participate in the study and were randomly assigned to intervention (n=40) and control (n=40) groups in a faculty hospital and a state hospital in Turkey. The use of virtual reality glasses will be taught to the postpartum women in the intervention group. After the initial mobilization, the postpartum women will be shown a nature view video with virtual reality glasses (VRG) accompanied by nature sounds for 20 minutes. The aim of this application is to enable women to watch nature images more effectively accompanied by nature sounds, thus allowing them to focus on the images and sounds, distract them, relax and remove them from the tension of the current environment. The application will be performed with the women in a semi-recumbent position and without sleeping. The same application will be applied to each woman and the glasses will be disinfected with Dermosept surface disinfectant, which provides cold sterilization, before the application. No application will be applied to the control group; only the general routine maintenance of the hospital will be performed. Data will be collected by the researcher through face-to-face interviews based on the statements of the women after cesarean section.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being over 18 years of ageBeing able to read and write in Turkish
* Giving birth at term, having a single, live and healthy baby
* The baby being with the mother
* Having a healthy/risk-free pregnancy
* Having had spinal anesthesia.

Exclusion Criteria:

* Having a diagnosed psychiatric disease,
* Having a mental disability and communication problem,
* Having a vision or hearing problem,
* Developing complications during or after a cesarean section,
* Having any obstacles to postpartum mobilization.

Primary outcomes:
measure: State Anxiety Level
timeFrame: Anxiety levels will be assessed 2 minutes before intervention and 2 minutes after the end of the intervention.
measure: Pain Level
timeFrame: Pain levels will be assessed 2 minutes before the intervention and 2 minutes after the end of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Gynecology and Obstetrics Department affiliated to the Gynecology and Obstetrics Department of Samsun Education and Research Hospital
Study officials:
affiliation: baltacinazli@gmail.com
name: Nazlı Baltacı, Assoc. Prof., phD
role: STUDY_DIRECTOR
affiliation: gizemturkkmen19@gmail.com
name: Gizem Türkmen, MSc Student
role: PRINCIPAL_INVESTIGATOR
References: