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Not yet recruitingNCT07796243Updated Sep 8, 2026

Video-Guided Jaw Relaxation and Breathing Exercises in Children With Burns

An interventional study of Video-Guided Jaw Relaxation and Video-Guided Breathing Exercise in Burn, sponsored by Izmir Katip Celebi University. Not yet recruiting. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study summary

This randomized controlled trial aims to evaluate the effects of video-guided jaw relaxation and video-guided breathing exercises on anxiety, fear, and dressing duration in children with burns. Children aged 4-10 years receiving inpatient care in a pediatric burn unit will be randomly assigned to one of three groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Children in the intervention groups will perform the assigned exercise simultaneously with a 5-minute video before burn dressing, while children in the control group will receive routine care. Anxiety and fear will be assessed at three time points: before the intervention (T1), immediately after the intervention and before dressing (T2), and immediately after dressing (T3). Dressing duration will also be recorded. The study will determine whether these brief, video-guided non-pharmacological interventions reduce anxiety and fear associated with burn dressing and affect dressing duration in children.

Read the 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.

02

Conditions studied

  • Burn

Keywords

  • anxiety
  • fear
  • wound dressing
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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.

  • 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

    Behavioral: Video-Guided Breathing Exercise

  • 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.

    Behavioral: Video-Guided Jaw Relaxation

Interventions

  • BehavioralVideo-Guided Jaw Relaxation

    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.

  • BehavioralVideo-Guided Breathing Exercise

    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.

06

What researchers measure

Primary outcomes

  1. Anxiety Level

    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.

    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).

  2. Fear Level

    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.

    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).

Secondary outcomes

  1. Wound Dressing Duration

    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.

    Time frame: During the burn dressing procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Individual participant data (IPD) will not be publicly shared due to the involvement of pediatric participants and considerations regarding participant privacy and confidentiality. Aggregated and anonymized study findings will be reported in scientific publications and presentations.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for Apr 2028, 10 months later.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 10 months is below that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 1, 2026
StartEst.
Jun 1, 2027
Primary completionEst.
Apr 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796243
Responsible party
ESRA ARDAHAN AKGUL (Asst. Prof., Izmir Katip Celebi University) — Principal investigator
First posted
Sep 1, 2026
Start date
Jun 1, 2027 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Esra Ardahan Akgül, PhD
study chair · İzmir Katip Çelebi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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