Burn Patient Care, Virtual Reality, Music, Pain, Anxiety and Pain Anxiety

NCT05688891 | Completed DMC

• 1 other identifier: 2022/514/221/7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PAIN; ANXIETY; PAIN ANXIETY

Keywords

Burn care; Pain; Anxiety; Pain anxiety; Nursing

Outcome Measures

Primary Outcomes (3)

• Pain evaluated using Visual Analog Scale

  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'.

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

• Anxiety evaluated using The State Anxiety Inventory

  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.

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

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

  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.

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

Secondary Outcomes (1)

• Anxiety evaluated using The Trait Anxiety Inventory

  State from baseline (before implementation)

Study Arms (3)

Virtual reality

EXPERIMENTAL

Before the procedure, "Visual Analogue Scale-VAS", "Spielberger State and Trait Anxiety Inventory", "Burn-Specific Pain Anxiety Scale" were filled in.5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened. Video monitoring with Virtual Reality continued throughout the entire dressing.This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings.After the procedure, the scales were filled again.

Other: Virtual reality

Music

EXPERIMENTAL

5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings.After the procedure, the scales were filled again.

Other: Music

Control

NO INTERVENTION

During the burn dressing procedure, no intervention method was used, and routine treatment and care interventions were continued.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings.

Interventions

Virtual reality OTHER

5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened. Audio and video settings were made and started to be watched. Video monitoring with Virtual Reality continued throughout the entire dressing. This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings.

Virtual reality

Music OTHER

5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing. After the process was finished, the music was turned off and the headphones were removed. This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings.

Music

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%,
• nd 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karabuk University: lead
• Prof. Dr. SEHER DENİZ ÖZTEKİN: collaborator

Study Sites (1)

Turkey, Istanbul University-Cerrahpasa

Istanbul, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: March 14, 2022
• Primary Completion: January 14, 2023
• Study Completion: November 17, 2023
• Last Updated: December 10, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)