NCT01568372

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

March 26, 2012

Last Update Submit

October 3, 2017

Conditions

Keywords

pediatrictonsillectomypain managementnurse follow-up

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

EXPERIMENTAL

This 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

Other: Telephone follow-up

Standard care group

NO INTERVENTION

This 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.

Also known as: Nursing interventions, Nursing follow-up
Nurse telephone follow-up

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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.

MeSH Terms

Conditions

PainAgnosia

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sylvie Le May, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

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

Locations