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

Primary Purpose

PAIN, ANXIETY, PAIN ANXIETY

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Music
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for PAIN focused on measuring Burn care, Pain, Anxiety, Pain anxiety, Nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Turkey, Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Virtual reality

Music

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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'.
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.
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.

Secondary Outcome Measures

Anxiety evaluated using The Trait Anxiety Inventory
In the trait anxiety scale, the number of reversed statements is seven and these make up the items 21, 26, 27, 30, 33, 36 and 39. On the trait anxiety scale, reversed statements the number of statements is seven and these make up Articles 21, 26, 27, 30, 33, 36 and 39. The scores obtained from both scales 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. The same is true when interpreting scores in percentile order. That is, the low percentile rank (1, 5, 10) indicates less anxiety. The average score level determined in the applications varies between 36 and 41.

Full Information

First Posted
January 9, 2023
Last Updated
January 19, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof. Dr. SEHER DENİZ ÖZTEKİN
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1. Study Identification

Unique Protocol Identification Number
NCT05688891
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
January 14, 2023 (Actual)
Study Completion Date
January 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof. Dr. SEHER DENİZ ÖZTEKİN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAIN, ANXIETY, PAIN ANXIETY
Keywords
Burn care, Pain, Anxiety, Pain anxiety, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain evaluated using Visual Analog Scale
Description
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'.
Time Frame
Change from baseline (before implementation) and 2th week of practice
Title
Anxiety evaluated using The State Anxiety Inventory
Description
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.
Time Frame
Change from baseline (before implementation) and 2th week of practice
Title
Pain Anxiety evaluated using The Burn Specific Pain Anxiety Scale (BSPAS)
Description
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.
Time Frame
Change from baseline (before implementation) and 2th week of practice
Secondary Outcome Measure Information:
Title
Anxiety evaluated using The Trait Anxiety Inventory
Description
In the trait anxiety scale, the number of reversed statements is seven and these make up the items 21, 26, 27, 30, 33, 36 and 39. On the trait anxiety scale, reversed statements the number of statements is seven and these make up Articles 21, 26, 27, 30, 33, 36 and 39. The scores obtained from both scales 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. The same is true when interpreting scores in percentile order. That is, the low percentile rank (1, 5, 10) indicates less anxiety. The average score level determined in the applications varies between 36 and 41.
Time Frame
State from baseline (before implementation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia GÖRÜCÜ, Master
Phone
+90 212-224-2618
Ext
27109
Email
raba_1622@hotmail.cm
Facility Information:
Facility Name
Turkey, Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia GÖRÜCÜ, master
Phone
5548517366
Email
raba_1622@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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