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- Klinische proef NCT07578883
Scar Mobilization Improves Scars and Quality of Life in Burned Children.
Effects of the Scar Tissue Mobilization on Scar Thickness, Pliability and Quality of Life in Children With Upper Extremity Burns.
Studie Overzicht
Gedetailleerde beschrijving
Burn injuries, especially to the upper extremities, are common in children and can lead to hypertrophic scarring, resulting in pain, stiffness, and reduced range of motion. These complications significantly impact a child's ability to perform daily activities and affect overall quality of life and development. Rehabilitation plays a vital role in recovery, with scar tissue mobilization being a key intervention to improve scar flexibility and function. While commonly used, there is limited evidence on its specific effects in pediatric upper limb burns. This study aims to assess the impact of scar tissue mobilization on scar thickness, pliability and quality of life in children with upper extremity burns.
The study design will be Quasi experimental study. The data will be collected from mayo hospital, Lahore. The study will be completed in 10 months after the approval of synopsis. Children aged 8 to 13 years old will be included in this study and each patient will receive the same intervention. The participants will receive scar tissue mobilization intervention for 15 minutes twice a week for 5 weeks. Participants fulfilling the eligibility criteria will be asked to assign the consent form before entering into the study. The scar thickness and pliability will be measure from the Vancouver Scar Scale (VSS) and quality of life with Brisbane Scar Impact Profile (BBSIP). The synopsis will be presented to Research Ethical Committee of Riphah International University, Lahore for ethical approval to conduct this study. Data will be analyzed through SPSS 27.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: IMRAN AMJAD, PhD
- Telefoonnummer: 9233224390125
- E-mail: IMRAN.AMJAD@RIPHAH.EDU.PK
Studie Contact Back-up
- Naam: Muhammad Asif Javed, MS-PT
- Telefoonnummer: 9233224209422
- E-mail: a.javed@riphah.edu.pk
Studie Locaties
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Werving
- Mayo Hospital
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Contact:
- IMRAN AMJAD, PhD
- Telefoonnummer: 9233224390125
- E-mail: IMRAN.AMJAD@RIPHAH.EDU.PK
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Contact:
- Muhammad Asif Javed, MS-PT
- Telefoonnummer: 923224209422
- E-mail: a.javed@riphah.edu.pk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 8-13 years
- Stable scar and referred for scar management
- Affected upper extremity joints (shoulder, elbow and wrist) with burned injuries
- Partial thickness and full thickness burn.
Exclusion Criteria:
- Pre-existing skin condition or allergies
- Neurological disorders affecting motor function
- Fracture with burn in upper limbs
- Patient with only superficial burns
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Scar Tissue Mobilization on Scars and Quality of Life in Pediatric Upper Extremity Burns
Patients received 15-minute massage sessions twice weekly for 5 weeks by the same therapist.
Techniques included moderate-pressure strokes around wounds.
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15-minute massage twice weekly for 5 weeks using baby oil by the same therapist.
Included moderate-pressure strokes, finger pressing, circular movements, skin rolling, and finishing gliding strokes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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vancouver scar scale
Tijdsspanne: Baseline, 5 week
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The Vancouver Scar Scale (VSS) is a widely used semi-quantitative tool for scar assessment that evaluates four parameters: vascularity, pigmentation, pliability, and height/thickness.
It has a total score range of 0-13/14, where 0 indicates normal skin and higher scores represent more severe scarring, including thick scars and contractures.
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Baseline, 5 week
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Brisbane burn scar impact profile (BBSIP)
Tijdsspanne: Baseline, 5 week
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A 40-item scale assessing children's quality of life across domains such as daily activities, hand function, appearance, psychological status, social relationships, and school activities.
Items are scored from 0 (not at all) to 4 (a lot), with total scores classified as good (40-80), fair (80-100), and poor (>100).
A 58-item burn scar-specific HRQoL self-report tool covering 10 domains including sensory, mobility, daily living, social interaction, appearance, and emotional reactions.
Items use dichotomous, 11-point, or 5-point Likert scales; scores are calculated per domain, with lower scores indicating better quality of life.
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Baseline, 5 week
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Areej Saher, MS-PT, Riphah International University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- REC/RCR&AHS/24/Areej Saher
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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