Clinical trial NCT05688891: Burn Patient Care, Virtual Reality, Music, Pain, Anxiety and Pain Anxiety
Official title: The Effect of Virtual Reality and Music on Pain, Anxiety and Pain Anxiety in Burn Patient Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PAIN
ANXIETY
PAIN ANXIETY
Keywords: Burn care
Pain
Anxiety
Pain anxiety
Nursing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Prof. Dr. SEHER DENİZ ÖZTEKİN
First posted: 2023-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain evaluated using Visual Analog Scale
timeFrame: Change from baseline (before implementation) and 2th week of practice
measure: Anxiety evaluated using The State Anxiety Inventory
timeFrame: Change from baseline (before implementation) and 2th week of practice
measure: Pain Anxiety evaluated using The Burn Specific Pain Anxiety Scale (BSPAS)
timeFrame: Change from baseline (before implementation) and 2th week of practice
Secondary outcomes:
measure: Anxiety evaluated using The Trait Anxiety Inventory
timeFrame: State from baseline (before implementation)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Turkey, Istanbul University-Cerrahpasa
Study officials:
References: