Last reviewed · How we verify
NCT05070325
Nonpharmacological Methods for Children
NA trial testing Cold application group in Child in 150 participants. Completed in 20 December 2018.
30 June 2018
Quick facts
| Lead sponsor | Bandırma Onyedi Eylül University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 150 |
| Start date | 1 November 2017 |
| Primary completion | 30 June 2018 |
| Estimated completion | 20 December 2018 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Cold application group
- Shotblocker group
- Control Group — full drug profile →
Conditions studied
- Child — all drugs for Child →
- Procedural Anxiety — all drugs for Procedural Anxiety →
- Procedural Pain — all drugs for Procedural Pain →
Sponsor
Bandırma Onyedi Eylül University
Who can join
Adults 7 to 12, any sex, with Child or Procedural Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of the methods of cold application and Shotblocker on the pain and anxiety level of the children in reducing the pain associated with the intramuscular injection. The hypotheses of the study: Hypothesis 0. Shotblocker and the cold application to the injection site prior to the injection are not effective in reducing the pain associated with the intramuscular injection in children. Hypothesis 1. Using ShotBlocker during the intramuscular injection reduces the pain and anxiety experienced by the child. Hypothesis 2. Applying cold to the injection site prior to the intramuscular injection reduces the pain and anxiety experienced by the child. This research was designed as a randomized controlled experimental study in a university hospital in Çorum. The sample of the study comprised 150 children aged 7 to 12 years who were brought to the pediatric injection room in a university hospital and had intramuscular injection. The children were randomized into the Shotblocker (n=50), cold application (n=50) and control (n=50) groups. In addition to Wong-Baker Pain Scale and Child Anxiety Scale, the Child Information Form was used in the study to determine the introductory characteristics of the children and their family.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05070325
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05070325 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bandırma Onyedi Eylül University
- Last refreshed: 15 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05070325.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing