- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07796243
Video-Guided Jaw Relaxation and Breathing Exercises in Children With Burns
Effects of Video-Guided Jaw Relaxation and Breathing Exercises on Anxiety, Fear, and Dressing Duration in Children With Burns: A Three-Arm Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Burn dressing procedures can be stressful and anxiety-provoking experiences for children. Repeated exposure to painful dressing procedures may contribute to anticipatory anxiety and fear, which can further complicate the child's experience of burn care. Non-pharmacological interventions may provide a simple and supportive approach to managing these responses alongside routine clinical care.
Jaw relaxation is a relaxation technique that does not require sequential contraction and relaxation of multiple muscle groups. The technique involves allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and maintaining a slow breathing rhythm consisting of inhalation, exhalation, and rest. Although jaw relaxation has been investigated in adults with burns, evidence regarding its use in children with burns is lacking. This study adapts the technique for children using a brief video-guided approach.
This study is designed as a three-arm randomized controlled trial involving children aged 4-10 years receiving inpatient treatment in a pediatric burn unit. A total of 60 children will be assigned to one of three groups: a video-guided jaw relaxation group, a video-guided breathing exercise group, or a control group. Children in the video-guided jaw relaxation group will watch a 5-minute video demonstrating jaw, tongue, and lip relaxation combined with a slow inhale-exhale-rest breathing rhythm and will perform the demonstrated exercises simultaneously. Children in the video-guided breathing exercise group will follow a 5-minute video demonstrating the same slow breathing rhythm without instructions related to relaxation of the jaw, tongue, or lips. The control group will receive routine care without either video-guided intervention.
Anxiety and fear will be assessed at three time points: before the intervention (T1), immediately after the intervention and before burn dressing (T2), and immediately after completion of the dressing procedure (T3). Anxiety will be assessed using the Children's Anxiety Meter-State, and fear will be assessed using the Child Fear Scale. The total duration of the dressing procedure will also be recorded using a stopwatch.
The study aims to determine and compare the effects of video-guided jaw relaxation and video-guided breathing exercises on anxiety, fear, and dressing duration in children undergoing burn dressing. The findings may provide evidence for a brief, developmentally appropriate, and easily applicable non-pharmacological intervention that can be integrated into pediatric burn care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children aged 4-10 years Receiving inpatient treatment in the Pediatric Burn Unit Having undergone at least three previous burn dressing procedures Able to communicate in Turkish No visual or hearing impairment that would prevent participation in the video-guided intervention No administration of an anxiolytic medication before the dressing procedure that could affect the study outcomes No burns involving the face or neck Child and parent/legal guardian willing to participate in the study and provide the required assent/consent
Exclusion Criteria:
Child or parent/legal guardian requesting withdrawal from the study Inability to tolerate or complete the assigned video-guided jaw relaxation or breathing exercise Development of a serious clinical complication or requirement for intensive care during data collection Inability or refusal to comply with the study protocol, including discontinuation or refusal of the assigned intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Children assigned to the control group will receive routine care without any video-guided relaxation or breathing intervention.
Anxiety and fear will be assessed at the same time points as in the intervention groups: before the dressing procedure (T1), immediately before dressing (T2), and immediately after completion of the dressing procedure (T3).
The total duration of the dressing procedure will also be recorded.
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|
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Active Comparator: Video-Guided Breathing Exercise Group
Intervention Description: Children assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing. The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video. The video will not include any instructions regarding |
Children assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing.
The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video.
The video will not include any instructions regarding relaxation of the jaw, tongue, or lips.
Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.
|
|
Active Comparator: Video-Guided Jaw Relaxation Group
Children assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing.
The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm.
Children will be instructed to perform the demonstrated exercises simultaneously while watching the video.
Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.
|
1. Video-Guided Jaw Relaxation Intervention Description: Children assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing. The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm. Children will be instructed to perform the demonstrated exercises simultaneously while watching the video. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Level
Time Frame: At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).
|
Anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S).
The CAM-S is a visual scale designed to assess children's current state anxiety.
Higher scores indicate higher levels of anxiety.
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At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).
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|
Fear Level
Time Frame: At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).
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Fear will be assessed using the Child Fear Scale (CFS), which consists of five facial expressions ranging from 0 (no fear) to 4 (severe fear).
Higher scores indicate higher levels of fear.
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At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound Dressing Duration
Time Frame: During the burn dressing procedure
|
The total duration of the burn dressing procedure will be measured using a stopwatch.
The measurement will begin at the start of the dressing procedure and end when the dressing procedure is completed.
Dressing duration will be recorded in minutes.
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During the burn dressing procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Esra Ardahan Akgül, PhD, İzmir Katip Çelebi University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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