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

NCT05496647 | Completed DMC

• 1 other identifier: MarmaraU-OZ-2022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Anxiety

Keywords

Nursing; Virtual Reality; Music Therapy,; Stress Ball; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  Fear of Pain Scale-III; Participants mark the option that best describes the severity of their fear according to their pain experiences regarding the items listed on the scale. In the scoring, it means that 1- fear is never heard, and 5-fear is excessive. The lowest score that can be obtained in total is 30, and the highest score is 150.The lowest score that can be obtained for the sub-dimensions is 10, and the highest score is 50. The higher the individual's score on the scale, the higher the fear of pain. Visual Analog Scale = VAS; In order to determine the severity of the pain experienced by the participants during and after the outpatient gynecological surgical procedure, score measurements in centimeters (cm) will be determined on the vertically prepared GCS. Visual Comparison Scale (0cm;No pain, 0.5cm- 3.0cm;Mild pain, 3.5cm-6.5cm;Moderate pain, 7.0cm-10.0cm;Severe pain).

  5 Months

Secondary Outcomes (4)

• Anxiety Intensity

  5 Months

• Patient Information Form

  5 Months

• Life Information Tracking Form

  5 Months

• Patient Satisfaction Evaluation Form

  5 Months

Study Arms (4)

Virtual Reality (VR)

EXPERIMENTAL

Virtual Reality Application (VR) VR group patients will be shown VR videos that include landscapes such as nature and the sea, giving people a feeling of comfort and peace, and making them feel like they are inside. During the surgical procedure, VR videos will be watched for an average of 20 minutes with X-brand VR glasses. In the research, similar studies will be examined and 360o VR video, which is a licensed product with atmospheric music background, containing relaxing nature images and nature sounds will be used.

Other: Virtual Reality

Music Therapy

EXPERIMENTAL

Music Therapy Application During the surgical procedure, an mp3 player, and music therapy CDs of uşşak and Hüseyni will be used. (Oline will also create a list from music platforms (fizzy-Spotify, etc.)) Before starting the procedure, the patients will be asked about their music preferences and the music will be played to the patients (20 minutes) during the procedure in line with their preferences. Headphones provided by the researcher will be used for patients with headphones, and for patients without headphones. The music authorities used (hüseyni and uşşak) will be provided and used by order, by obtaining the necessary permissions from the official site of TÜMATA.

Other: Music Therapy

Stress Ball Application

EXPERIMENTAL

Stress Ball Application A sufficient number of stress balls will be provided by the investigator for each patient to use separately before starting the study. Before starting the day-to-day gynecological surgery, patients in the stress ball group will be given a round, colored, medium-hard, compressible Knaftmed ball made of high-quality silicone. To avoid implying that the procedure is inherently stressful, it will be referred to as a squeezing ball when instructing patients about stress ball application. During the surgical procedure, it will be said that he can squeeze the stress ball as often as he wants for about 20-25 minutes and the stress ball will be given to each patient.

Other: Stress Ball Application

Control

EXPERIMENTAL

During the process; Women in the control group will not undergo any intervention other than routine surgery.

Other: Control

Interventions

Virtual Reality OTHER

Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; the Preferred video will be watched with Virtual Reality Glasses for approximately 20 minutes during the process, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form, Visual Comparison Scale will be filled. 2\. Measurements After Daily Gynecological Surgery; At the 1st hour after the procedure, Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3\. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale and Satisfaction Evaluation Form will be filled.

Virtual Reality (VR)

Music Therapy OTHER

Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; During the procedure, the preferred music for Music Therapy will be played for approximately 20 minutes, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2\. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3\. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.

Music Therapy

Stress Ball Application OTHER

Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; the Stress ball will be played for approximately 20 minutes during the process. After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2\. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3\. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.

Stress Ball Application

Control OTHER

Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; Women in the control group will not undergo any intervention other than routine surgery. After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2\. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3\. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure, the Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who will undergo daily gynecological surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old,
• Can speak Turkish,
• Subjected to daily gynecological surgery for the first time,
• Does not have any psychiatric disease and mental perception problems,
• Having no vision, hearing, and perception problems,
• Having no physical problems squeezing a stress ball,
• There will be women who agree to participate in the research verbally and in writing.

You may not qualify if:

• Having used analgesic or anesthetic drugs within 24 hours before or during the procedure
• Using antidepressant, anxiolytic and sedative drugs
• Communication difficulties and mental disability
• Patients with severe vision and hearing problems, and physical disabilities (with open wounds on their hands, insufficient muscle strength to squeeze a stress ball) will not be included in the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tuğba öz, PhD RN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Criteria for Inclusion in the Research * Over 18 years old, * Can speak Turkish, * Subjected to daily gynecological surgery for the first time, * Does not have any psychiatric disease and mental perception problems, * Having no vision, hearing, and perception problems, * Having no physical problems squeezing a stress ball, * There will be women who agree to participate in the research verbally and in writing.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, Professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: June 15, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

TU (1)