Expired Study
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Norfolk, Virginia 23507


Purpose:

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.


Study summary:

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)


Criteria:

Inclusion Criteria: - infants with a gestational age between 32-42 weeks at delivery and post-natal age of less than 20 weeks old Exclusion Criteria: - acetaminophen or ibuprofen administration within 4 hours prior to immunization, current neurological disorder, known genetic anomaly, moderate to severe illness with or without fever at the time of vaccination, anaphylactic reaction to previous dose of vaccine, or if infant was previously enrolled in the study at 2 months.


Study is Available At:


Original ID:

EVMS


NCT ID:

NCT01368861


Secondary ID:


Study Acronym:


Brief Title:

Effective Analgesia During Routine Immunizations


Official Title:

Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

2 Months


Maximum Age:

4 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital of The King's Daughters


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

230


Enrollment Type:

Actual


Overall Contact Information

Official Name:John W Harrington, MD
Principal Investigator
Children's Hospital of The King's Daughters

Study Dates

Start Date:June 2010
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:July 2015
Last Changed Date:July 28, 2015
First Received Date:June 3, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:To measure 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.
Time Frame:every 15 sec
Safety Issues:False
Description:Does the 5 S's improve the percieved pain of infants receiving vaccinations. The Modified Riley Pain Scale which measure 3 aspects of pain was utilized. The scale is validated for the assessment of acute pain in preterm and term infants.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:control
Description:water and normal physical comfort provided by mom
Study Arm Type:Other
Arm Name:sucrose
Description:sugar and normal physical comfort provided by mom
Study Arm Type:Other
Arm Name:physical intervention
Description:physical intervention using the 5 S's and water
Study Arm Type:Other
Arm Name:physical intervention and sucrose
Description:Physical intervention using the 5 S's and sugar water

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital of The King's Daughters

Samples and Retentions

Study Population: All patients were enrolled from the General Academic Pediatric outpatient practice located at The Children's Hospital of The King's Daughters in Norfolk, VA. This practice serves a predominantly urban, Medicaid enrolled, African-American population and has approximately 30,000 annual visits per year.
Sample Method:Probability Sample

Study References

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Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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PMID:11927701
Reference Type:Reference
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Reference Type:Reference
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Reference Type:Reference
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PMID:20937658
Reference Type:Reference
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PMID:20091512
Reference Type:Reference
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PMID:19837254
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Reference Type:Reference
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PMID:11257372
Reference Type:Reference
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Reference Type:Reference
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PMID:10475601

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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