Clinical trial NCT05032586: The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children
Official title: The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear and Anxiety
Keywords: anxiety
burn dressing
child
fear
pain
virtual reality
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 65
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: parallel assigment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was conducted to determine the effect of VR on the pain, anxiety, and fear levels experienced by patients during burn dressing. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65).

Detailed description: Burn injuries are considered one of the most severe physical and psychosocial traumas a person can face. Burn injuries, especially in the childhood, are an important health problem that causes long-term psychological and physiological consequences and includes rehabilitation processes that continue for years.

During burn treatment, wound debridement, daily dressing change, repair surgeries, and applications during hospitalization cause serious pain, physical stress, and psychological damage to the patient in burn injuries, as in all injuries. Anxiety, loss of control, hopelessness, disruption of body integrity, and pain during burns and procedures during the treatment process are early traumatic features of the burn.

Since pain is not only a sensory experience but also an emotional and cognitive experience, using pharmacological treatment methods alone may not be sufficient. Using nonpharmacological methods in addition to pharmacological methods is recommended in order to control the pain that occurs during wound care and reduce the dose of analgesic administered. The distraction technique is one of the most frequently preferred nonpharmacological methods to reduce pain perception during dressing and control fear and anxiety in children hospitalized in the clinic due to burns. It is a method included in the Nursing Interventions Classification taxonomy.

When the literature was examined, it was observed that there are a limited number of studies examining the effect of VR on pain and anxiety in children during burn dressing. However, there was no study evaluating the fear experienced during burn dressing in children. This study aimed to propagate the use of VR, which is a potentially important technology for nursing care and multidisciplinary healthcare team and has an important place in the treatment of burn patients by reducing the level of pain and anxiety experienced by patients. It is thought that the result of the research will shed light on how to reduce pain, fear, and anxiety experienced during dressing and contribute to the literature as an evidence-based nonpharmacological method.

The research is a randomized controlled experimental study conducted between April 2019 and September 2020. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65). The data were collected using the Descriptive Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale, and State-Trait Anxiety Inventory for Children. In addition, oxygen saturation and heart rate measurements were recorded before and after the procedure.

Eligibility criteria: Inclusion Criteria:

* being in the 7-12 age group,
* not having any dressing in the burn center before
* having a second degree superficial and deep burn
* having burns with a percentage of less than 10%,
* having upper and lower extremity burns
* not having any chronic disease other than burns,
* being willing to participate in the study,
* not having any mental and communication problems and visual impairments

Exclusion Criteria:

* being \<7 and \>12 years old
* having previous dressing in the burn center,
* having a 1st or 3rd degree burn area,
* having burns on the head, trunk, and genital area,
* having chronic illness other than burns any
* not being willing to participate in the study

Primary outcomes:
measure: Descriptive Information Form
timeFrame: up to 1 hour
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: up to 1 hour
measure: Children's Fear Scale
timeFrame: up to 1 hour
measure: State-Trait Anxiety Inventory for Children (STAI-C)
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: TURKEY
state: Yakutiye
Study officials:
References: