BurnNCT07796243
Video-Guided Jaw Relaxation and Breathing Exercises in Children With Burns
A study testing Video-Guided Jaw Relaxation and Video-Guided Breathing Exercise in people with Burn, run by Izmir Katip Celebi University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Burn
- What is being tested?
- Video-Guided Jaw Relaxation and Video-Guided Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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.
- Conditions
- Burn
- Being tested
- Video-Guided Jaw Relaxation, Video-Guided Breathing Exercise
- Keywords
- anxiety, fear, wound dressing
- Medical subject headings
- Burns, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Guided Jaw RelaxationBehavioural
- 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.
Video-Guided Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Video-Guided Breathing Exercise Group | Active comparator | 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 Receives: Behavioral: Video-Guided Breathing Exercise |
| Video-Guided Jaw Relaxation Group | Active comparator | 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. Receives: Behavioral: Video-Guided Jaw Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).
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.
Measured: 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.
Measured: During the burn dressing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Each participant will remain in the assigned group throughout the study, with no crossover between interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Esra Ardahan Akgül, PhD, Study chair, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796243
- Sponsor's protocol ID
- 27826
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07796243
- Acronym / sponsor ID
- 27826
- Conditions
- Burn
- Keywords
- anxiety, fear, wound dressing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Each participant will remain in the assigned group throughout the study, with no crossover between interventions.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Video-Guided Breathing Exercise Group | Active comparator | Behavioral: Video-Guided Breathing ExerciseIntervention 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 |
| Video-Guided Jaw Relaxation Group | Active comparator | Behavioral: Video-Guided Jaw RelaxationChildren 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Guided Jaw Relaxation1. 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. | Behavioural | Video-Guided Jaw Relaxation Group |
| Video-Guided Breathing ExerciseChildren 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. | Behavioural | Video-Guided Breathing Exercise Group |
Primary outcome
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.
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).
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.
1 secondary outcome
Wound Dressing Duration
Time frame: During the burn dressing procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esra Ardahan Akgül, PhD study chair
İzmir Katip Çelebi University
Questions about this trial
What is this clinical trial studying?
A study testing Video-Guided Jaw Relaxation and Video-Guided Breathing Exercise in people with Burn, run by Izmir Katip Celebi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.