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NCT01379885 · ClinicalTrials.gov registry record · NA
Reducing Immunization Distress (RID)
A NA study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- NA
- Development phase
- 77
- Enrollment target
NCT01379885: Clinical Trial NA study, sponsored by University of California, San Francisco.
NCT01379885 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 77 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379885, a NA study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience. Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to: 1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome); 2. Parent report of child pain using the FPS-R; 3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14; 4. Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales; 5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.
Primary Outcome
Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale (primary outcome); Parent report of child pain using the FPS-R.
Interventions
- BEHAVIORAL Standard technique
- BEHAVIORAL Parent participation technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-01 |
| Phase | NA |
Why NCT01379885 stopped before completion
NCT01379885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard technique is the first listed.
NCT01379885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01379885 about?
NCT01379885 is a clinical study titled "Reducing Immunization Distress (RID)". The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child s...
What is the current status of trial NCT01379885?
This trial is currently terminated. It is a NA study. The enrollment target is 77 participants. The study started on 2011-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01379885?
The interventions under investigation include: Standard technique (BEHAVIORAL), Parent participation technique (BEHAVIORAL).
Who is sponsoring clinical trial NCT01379885?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01379885's enrollment target sits among peer trials
77 1062nd of 2000 higher than 939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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