Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT01368861
Brief Summary:
The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits.
Detailed Description:
Study Procedure
Infants meeting inclusion criteria were identified daily by reviewing the list of patients scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal guardian was approached prior to vaccination by the research assistant for participation in the study. If the parent/guardian accepted to participate in the vaccine study, the consenting process was performed and patients were brought to a designated examination room. Infants of parents or guardians who consented were randomly assigned to one of four study groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40 cards, which were recycled with each group of 40 infants enrolled into the study. The four groups of the study included:
1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after Immunization (Control Group)
2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or guardian after immunization (Sucrose Group)
3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical Group)
4. 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical and Sucrose Group)
Study:
NCT01368861
Study Brief:
Protocol Section:
NCT01368861