Burn PatientsNCT07853794
Effect of Psychosocial Intervention on Body Image, Self Esteem, Burn Anxiety and Depression Among Patients With Burn
A study testing Psychosocial Intervention in people with Burn Patients and Psychosocial, run by Ain Shams University at 1 site in Egypt.
Trial summary
Burn injuries are a widespread health problem, one of the most devastating injuries, and the fourth frequent most type of trauma following traffic accidents, falls, and interpersonal violence, causing death and disability worldwide According the world health organization, an estimated 180 000 deaths every year are… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Patients, Psychosocial, Body Image
- What is being tested?
- Psychosocial Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranged between 18-60 years old.
- The range of the body surface area affected by burns should fall within 10-40%.
- Burning levels must be categorized as 1, 2, or 3
- Patients able to communicate and willing cooperate with researcher in the program.
Who cannot join
- Patient with severe cognitive functions and disability.
- Patients are currently participating in another burn Program.
Trial locations and contacts
1 site in 1 country.
About this study
Burn injuries are a widespread health problem, one of the most devastating injuries, and the fourth frequent most type of trauma following traffic accidents, falls, and interpersonal violence, causing death and disability worldwide According the world health organization, an estimated 180 000 deaths every year are caused by burns .Psychosocial Intervention enhancing psychological and social well-being of patients affected with burns, enable to regain functionality and help the patients return to the highest level of independence through increased satisfaction, improve coping, and reduced post-traumatic stress .So the study aims to evaluate the effect of psychosocial intervention on Body Image, Self Esteem, Burn Anxiety and Depression among patients with burn.
Read the detailed description
The study aims to evaluate the effect of psychosocial intervention on body Image, self-esteem, burn anxiety and depression among patients with burn through:
- Assessing the burn anxiety, burn depression, body image satisfaction and self-esteem among patients with burn.
- Develop and implement of psychosocial intervention.
- Evaluating the effect of psychosocial intervention on body Image, self-esteem, burn anxiety and depression among patients with burn.
A purposive sample of patients with burn composed of 64 cases (control group) and 64 cases (study group) have the following:
Inclusion criteria:
- Age ranged between 18-60 years old.
- Both genders.
- The range of the body surface area affected by burns should fall within 10-40%.
- Patients able to communicate and willing cooperate with researcher in the program.
- Conditions
- Burn Patients, Psychosocial, Body Image, Self Esteem, Anxiety, Depression
- Being tested
- Psychosocial Intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial InterventionBehavioural
Psychosocial Intervention enhancing psychological and social well-being of patients affected with burns, enable to regain functionality and help the patients return to the highest level of independence through increased satisfaction, improve coping, and reduced post-traumatic stress.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | participants who didn't receive the psychosocial intervention but were observed and assessed at the same time points (before and after the intervention) for comparison with the study group |
| Study Group | Other | Participants who received the psychosocial intervention and were assessed before and after the intervention Receives: Behavioral: Psychosocial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image Satisfaction Rating Scale (BISRS)
This tool was used to measure level of body image satisfaction among patients with burn. It included eighteen questions
The scoring system:
Include the 18 questions using five options, which were strongly disagree= one, disagree = two, neither agree = three, agree = four, strongly agree= five to select the option that best represents them.
A total score ranging from 18 to 90.
- 18-32.4 very dissatisfied.
- 32.5-46.9 dissatisfied.
- 47-61.4 neither satisfied.
- 61.5-75.9 satisfied.
- 76-90 very satisfied.
Measured: baseline and 6 months after intervention
Self-Esteem Scale (RSE)
This tool was used to measure level of self-esteem among patients with burn.
The scoring system:
Include the 10 questions using four options, which were strongly agree= one, agree = two, disagree = three, strongly disagree= four to select the option that best represents them.
- 10-20 Low self-esteem.
- 21-30 Moderate self-esteem.
- 31-40 High self-esteem.
Measured: Baseline and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start26 Jan 2026
- Primary completion30 Jul 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853794
- Sponsor's protocol ID
- 26.08.1433
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychosocial Intervention on Body Image, Self Esteem, Burn Anxiety and Depression Among Patients With Burn
- ClinicalTrials.gov ID
- NCT07853794
- Acronym / sponsor ID
- 26.08.1433
- Conditions
- Burn Patients, Psychosocial, Body Image, Self Esteem, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 2 Oct 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.
Burn injuries are a widespread health problem, one of the most devastating injuries, and the fourth frequent most type of trauma following traffic accidents, falls, and interpersonal violence, causing death and disability worldwide According the world health organization, an estimated 180 000 deaths every year are caused by burns .Psychosocial Intervention enhancing psychological and social well-being of patients affected with burns, enable to regain functionality and help the patients return to the highest level of independence through increased satisfaction, improve coping, and reduced post-traumatic stress .So the study aims to evaluate the effect of psychosocial intervention on Body Image, Self Esteem, Burn Anxiety and Depression among patients with burn.
Detailed description
The study aims to evaluate the effect of psychosocial intervention on body Image, self-esteem, burn anxiety and depression among patients with burn through:
- Assessing the burn anxiety, burn depression, body image satisfaction and self-esteem among patients with burn.
- Develop and implement of psychosocial intervention.
- Evaluating the effect of psychosocial intervention on body Image, self-esteem, burn anxiety and depression among patients with burn.
A purposive sample of patients with burn composed of 64 cases (control group) and 64 cases (study group) have the following:
Inclusion criteria:
- Age ranged between 18-60 years old.
- Both genders.
- The range of the body surface area affected by burns should fall within 10-40%.
- Patients able to communicate and willing cooperate with researcher in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –participants who didn't receive the psychosocial intervention but were observed and assessed at the same time points (before and after the intervention) for comparison with the study group |
| Study Group | Other | Behavioral: Psychosocial InterventionParticipants who received the psychosocial intervention and were assessed before and after the intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged between 18-60 years old.
- The range of the body surface area affected by burns should fall within 10-40%.
- Burning levels must be categorized as 1, 2, or 3
- Patients able to communicate and willing cooperate with researcher in the program.
Key exclusion criteria (2 listed)
- Patient with severe cognitive functions and disability.
- Patients are currently participating in another burn Program.
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 |
|---|---|---|
| Psychosocial InterventionPsychosocial Intervention enhancing psychological and social well-being of patients affected with burns, enable to regain functionality and help the patients return to the highest level of independence through increased satisfaction, improve coping, and reduced post-traumatic stress. | Behavioural | Study Group |
Primary outcome
Body Image Satisfaction Rating Scale (BISRS)
Time frame: baseline and 6 months after intervention
This tool was used to measure level of body image satisfaction among patients with burn. It included eighteen questions The scoring system: Include the 18 questions using five options, which were strongly disagree= one, disagree = two, neither agree = three, agree = four, strongly agree= five to select the option that best represents them. A total score ranging from 18 to 90. * 18-32.4 very dissatisfied. * 32.5-46.9 dissatisfied. * 47-61.4 neither satisfied. * 61.5-75.9 satisfied. * 76-90 very satisfied.
Self-Esteem Scale (RSE)
Time frame: Baseline and 6 months after intervention
This tool was used to measure level of self-esteem among patients with burn. The scoring system: Include the 10 questions using four options, which were strongly agree= one, agree = two, disagree = three, strongly disagree= four to select the option that best represents them. * 10-20 Low self-esteem. * 21-30 Moderate self-esteem. * 31-40 High self-esteem.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention in people with Burn Patients and Psychosocial, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Image Satisfaction Rating Scale (BISRS) (time frame: baseline and 6 months after intervention). 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 2 Oct 2026.