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Clinical Trials/NCT05688891
NCT05688891
Completed
Not Applicable

The Effect of Virtual Reality and Music on Pain, Anxiety and Pain Anxiety in Burn Patient Care

Karabuk University1 site in 1 country120 target enrollmentMarch 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PAIN
Sponsor
Karabuk University
Enrollment
120
Locations
1
Primary Endpoint
Anxiety evaluated using The State Anxiety Inventory
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety in burn patients during dressing changes and debridement.

In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care.

Detailed Description

Wound debridement, wound care, surgical interventions and other invasive procedures applied during burn treatment cause the patient to feel pain, and the repeated pain process creates anxiety in the patient. In the studies in the literature, it is stated that anxiety and pain are closely related, pain affects the level of anxiety and anxiety affects the severity of pain. The role of nurses in the burn team is very important in the management of pain and anxiety in the treatment of burns, which have both physiological and psychological effects. The most important responsibility of the nurse in burn patient care is continuous and individualized pain diagnosis and management. Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety. Music is widely used to reduce pain and anxiety in burn patients during dressing changes and debridement. Virtual reality (VR) glasses, which facilitate daydreaming and daydreaming, are another method used to reduce pain and anxiety. With the development of technology, the use of virtual reality glasses by nurses as a method of distraction, especially in burn patients, is increasing. In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care. The sample group was selected in accordance with the research criteria from the individuals in the population who were given permission to participate in the research after the purpose of the research was explained. Within the scope of the planned study, the sample size to be used in determining the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care, effect size d= 0.485 (effect size), α=0.05 ( margin of error), 1-β With the help of the G-power (version 3.1) package program, a total of 120 people (at least 40 people in each group) were calculated, as =0.80 (power). A list was created for 120 patients who met the inclusion criteria in the study and distributed to the experimental and control groups using a computerized randomization program.

Registry
clinicaltrials.gov
Start Date
March 14, 2022
End Date
November 17, 2023
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karabuk University
Responsible Party
Principal Investigator
Principal Investigator

RABİA GÖRÜCÜ

research assistant

Istanbul University - Cerrahpasa

Eligibility Criteria

Inclusion Criteria

  • be between the ages of 18-65,
  • Ability to read, write and speak Turkish,
  • Not participating in another clinical trial at the same time,
  • Not having any problems that prevent cognitive, affective and verbal communication,
  • Having a patient group with a burnt total body area (TBSA) of less than 15%,
  • 2nd degree and 3rd degree patient group in the granulation stage,
  • No burns on the head, ears and face,
  • Being a patient group with daily dressing changes and dressing frequency of 1-15,
  • Absence of complaints such as respiratory problems that would prevent him from participating in the study,
  • Absence of vision and hearing problems.

Exclusion Criteria

  • Pain intensity is between 8-10 points,
  • Being under the influence of pharmacological or non-pharmacological intervention that will affect the pain,
  • Being a first degree patient group,
  • Having neurological, psychological and psychiatric diseases,
  • Burns on the head, ears and face,
  • Having vision and hearing problems,
  • Applying sedation to the patient during the dressing,
  • Stop watching VR glasses during dressing,
  • Stop listening to music during dressing.

Outcomes

Primary Outcomes

Anxiety evaluated using The State Anxiety Inventory

Time Frame: Change from baseline (before implementation) and 2th week of practice

It is a self-assessment scale consisting of twenty items developed by Spielberger et al. (1970) to determine state anxiety levels. The Turkish validity and reliability study of this scale was performed by Öner and LeCompte (1977), and the internal consistency (Cronbach's Alpha) coefficients were found to be between 0.83 and 0.92 for the state anxiety scale (Öner \& LeCompte, 1998). Higher total scores on the scale indicate a high level of state anxiety. The response options collected in four classes in the state anxiety scale are (1) Not at all, (2) Somewhat, (3) A lot, and (4) Completely. There are ten reversed statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The scores obtained in the scale theoretically vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

Pain evaluated using Visual Analog Scale

Time Frame: Change from baseline (before implementation) and 2th week of practice

Visual Analog Scale (VAS) is the most frequently used and simplest to use scale. In the scale with numbers between 0-10, "0" defines painlessness and "10" defines the most severe pain. In order to define the numerical value of the patient's pain/anxiety severity, the patient is asked to mark the ruler consisting of a 10 cm line, and the patient's pain severity score is determined as a result of the measurement. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.

Pain Anxiety evaluated using The Burn Specific Pain Anxiety Scale (BSPAS)

Time Frame: Change from baseline (before implementation) and 2th week of practice

The Burn Specific Pain Anxiety Scale (BSPAS) is another tool which evaluates pain related anxiety in burn patients. For each question in this scale, 0 "never" and 10 "worst possible" are accepted. The scale total score is calculated by summing the scores of all items and the lowest score is 0 and the highest score is 80. The higher the total score, the higher the anxiety experienced by the patient about painful procedures while in the hospital.

Secondary Outcomes

  • Anxiety evaluated using The Trait Anxiety Inventory(State from baseline (before implementation))

Study Sites (1)

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