- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: IMRAN AMJAD, PhD
- Telefonnummer: 9233224390125
- E-Mail: IMRAN.AMJAD@RIPHAH.EDU.PK
Studieren Sie die Kontaktsicherung
- Name: Muhammad Asif Javed, MS-PT
- Telefonnummer: 9233224209422
- E-Mail: a.javed@riphah.edu.pk
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Rekrutierung
- Mayo Hospital
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Kontakt:
- IMRAN AMJAD, PhD
- Telefonnummer: 9233224390125
- E-Mail: IMRAN.AMJAD@RIPHAH.EDU.PK
-
Kontakt:
- Muhammad Asif Javed, MS-PT
- Telefonnummer: 923224209422
- E-Mail: a.javed@riphah.edu.pk
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
vancouver scar scale
Zeitfenster: Baseline, 5 week
|
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)
Zeitfenster: Baseline, 5 week
|
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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Areej Saher, MS-PT, Riphah International University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- REC/RCR&AHS/24/Areej Saher
Plan für individuelle Teilnehmerdaten (IPD)
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