Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to determine if a nurse telephone follow-up to parents of children who underwent a removal of their tonsils would be effective in reducing pain intensity, complications and resort to other healthcare services
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started May 2010
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedOctober 5, 2017
October 1, 2017
5 months
March 26, 2012
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain intensity scores on the 3rd day after surgery
Mean pain intensity score on the 3rd postoperative day (POD)
Pain assessed on the 3rd postoperative day
Pain intensity scores on the 5th day after surgery
Mean pain intensity score on the 5th postoperative day (POD)
Pain assessed on the 5th postoperative day
Pain intensity scores on the 10th day after surgery
Mean pain intensity score on the 10th postoperative day (POD)
Pain assessed on the 10th postoperative day
Secondary Outcomes (1)
postoperative complications
Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day
Study Arms (2)
Nurse telephone follow-up
EXPERIMENTALThis group received a telephone follow-up by a nurse following discharge from the hospital and up until the 10th postoperative day, which is considered as the usual period of healing for a tonsillectomy
Standard care group
NO INTERVENTIONThis group received the standard care which consisted of an informative session before discharge and no follow-up once discharged home.
Interventions
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
Eligibility Criteria
You may qualify if:
- ASA I or II
- Elective surgery for tonsillectomy
- Parents or children able to read, and understand French or English
- Family equipped with a phone at home
- Child discharged home after the surgery
You may not qualify if:
- Abused cases
- Children with a cognitive deficit
- Children suffering from chronic pain
- Child who had another surgical procedure within a month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Ste.Justine's
Montreal, Quebec, H3T 1C5, Canada
Related Publications (1)
Paquette J, Le May S, Lachance Fiola J, Villeneuve E, Lapointe A, Bourgault P. A randomized clinical trial of a nurse telephone follow-up on paediatric tonsillectomy pain management and complications. J Adv Nurs. 2013 Sep;69(9):2054-65. doi: 10.1111/jan.12072. Epub 2013 Jan 13.
PMID: 23311981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Le May, PhD
Université de Montréal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Clinician Specialist
Study Record Dates
First Submitted
March 26, 2012
First Posted
April 2, 2012
Study Start
May 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 5, 2017
Record last verified: 2017-10