NCT05496647

Vırtual Reality, Music Therapy and Stress Ball-related Pain and Anxiety

Completed NA Last updated 14 March 2023

What this trial tests

NA trial testing Virtual Reality in Pain in 160 participants. Completed in 30 July 2022.

Timeline

15 June 2022

Primary endpoint
30 July 2022

30 July 2022

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	160
Start date	15 June 2022
Primary completion	30 July 2022
Estimated completion	30 July 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Virtual Reality
• Music Therapy
• Stress Ball Application
• Control

Conditions studied

• Pain — all drugs for Pain →
• Anxiety — all drugs for Anxiety →

Sponsor

Marmara University

Who can join

18 and older, female only, with Pain or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Outpatient surgical interventions; It is defined as surgical applications where the application time is short, the risk of complications is low, there is no need for intensive care after the intervention, and the patients can be discharged on the same day. It is applied in areas such as otolaryngology and maxillofacial surgery. Among all these areas, gynecological surgery is the area where the most outpatient surgery is performed. Some of the gynecological procedures that are generally applied in day surgery are as follows; Colposcopy, hysteroscopy, laparoscopy, dilatation-curettage, laparoscopic tubal ligation, treatment of the cervix with cautery or laser, removal of vulvar cysts, laser conization, cervical polypectomy and removal of Bartholin cysts.

In many state hospitals in our country, in daily gynecological surgical procedures; in some cases by premedication, in some cases under local anesthesia; however, patients are usually processed without anesthesia.

Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years.

Music therapy is defined as "the systematic use of music in a therapeutic relationship aimed at improving, maintaining and advancing emotional, physical and mental health". Music therapy has important physiological effects that reduce heart rate, blood pressure, body temperature, and respiratory rate, distract attention, increase the quality of life of patients, and reduce pain.

Stress ball emerges as a simple, reliable, inexpensive, and easily accessible method that helps patients reduce their anxiety. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing feelings of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. Based on all these reasons; The aim of this study is to determine the effects of virtual reality, music therapy, and stress ball applications on vital signs, pain, anxiety, and patient satisfaction during daily gynecological surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.