None listed
Conditions
Brief summary
This study aims to evaluate the effect of thermotherapy on the performance of peripheral venous blood sampling in pediatric patients. Warm gel packs are applied before venipuncture to improve vein dilation and potentially reduce anxiety. Children aged 6 months to 17 years are allocated to an intervention group (thermotherapy plus Romla cream) or a control group (Romla cream only). A demonstrative subgroup undergoes ultrasound imaging to document venous changes before and after thermotherapy. The study compares venipuncture success, anxiety levels, and parent satisfaction between groups.
Interventions
The intervention consists of applying a children’s warm pack to the venipuncture site in addition to standard topical anesthesia with Romla cream. All patients in the intervention group first receive Romla cream according to clinical protocol, followed by the application of a plush-covered warm pack filled with thermal beads, heated to approximately 50–60°C and applied for about 10 minutes to promote venous dilation. After removal of the warm pack, standard skin disinfection is performed and ven
The intervention consists of applying a children’s warm pack to the venipuncture site in addition to standard topical anesthesia with Romla cream. All patients in the intervention group first receive Romla cream according to clinical protocol, followed by the application of a plush-covered warm pack filled with thermal beads, heated to approximately 50–60°C and applied for about 10 minutes to promote venous dilation. After removal of the warm pack, standard skin disinfection is performed and venipuncture is carried out according to clinical guidelines by a trained pediatric nurse. The intervention is administered once, immediately before the blood draw. Adherence to the intervention protocol is monitored by the pediatric nurse and documented in the patient’s medical record.
Sponsors
Emergency Clinical Hospital for Children Cluj-Napoca
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
Age between 6 months and 17 years. Admitted for day-care hospitalization (day admission). Accompanied by a parent or legal guardian who can provide informed consent. Requires peripheral venous blood sampling as part of medical care. Eligible to receive either Romla cream or no topical anesthesia, according to the study group allocation. Parent and child (when applicable) are willing to participate in all study procedures. Medically stable at the time of inclusion. No known allergies to thermotherapy materials, warm gel packs, or components of Romla cream (when applicable).
Exclusion criteria
Age outside the 6 months–17 years range. The child is not accompanied by a parent or legal guardian able to provide informed consent. The parent or legal guardian does not provide consent for the child’s participation. Known allergy to warm gel packs, thermotherapy materials, or Romla cream (when applicable). Critical medical condition or any illness that may contraindicate the use of thermotherapy (e.g., severe cardiac instability, impaired skin integrity, dermatological infections, acute fever, peripheral circulatory disorders). Any medical instability identified by the attending clinician that prevents safe participation. Refusal of participation by the parent or by the child (when age-appropriate).
Outcome results
None listed