NCT04306679

Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery

Completed NA Last updated 13 March 2020

What this trial tests

NA trial testing Animation clips in Surgery in 98 participants. Completed in 21 November 2019.

Timeline

20 June 2019

Primary endpoint
20 November 2019

21 November 2019

Quick facts

Lead sponsor	University of Haifa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	98
Start date	20 June 2019
Primary completion	20 November 2019
Estimated completion	21 November 2019
Sites	1 location across Israel

Drugs / interventions tested

• Animation clips
• Instructions

Conditions studied

• Surgery — all drugs for Surgery →

Sponsor

University of Haifa

Who can join

Adults 8 to 17, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Treating pain, just as treating other medical conditions, depends on accurate assessment of patient's condition. When assessing pain, as other subjective symptoms, the challenge is twofold because the assessment is dependent on patient's understanding and use of the scale, all the more so in children

So far, attempts to improve pain assessments have been focused on the development and refining pain scales. No emphasis has been placed on improving patient's ability to report their pain. Our purpose is to evaluate a training program designed to improve the quality of children's post-surgical pain intensity reports.

After receiving Helsinki approval, eligible children and their parents will signed informed-consent. After surgery, the children, their parents, and the department nurses will assess children's pain intensity. Immediately after the nurse assessment, parents will assess their child's pain (blindly and independently) and the children will report their pain on four different pain scales.

Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be invited to participate. Children in the experimental group will be exposed to a training program, developed for this study, aimed to teach and train how to report pain. The control group will receive the standard pre-surgical instructions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Agreement between children's, nurses' and parents' pain intensity reports is stronger before than after analgesic consumption: Results from a post-operative study.
   Zontag D, Kuperman P, Honigman L, Treister R. · · 2022 · cited 7× · PMID 35395574 · DOI 10.1016/j.ijnurstu.2022.104176
2. Effects of Pain-Reporting Education Program on Children's Pain Reports-Results From a Randomized Controlled Post-operative Pediatric Pain Trial.
   Zontag D, Honigman L, Kuperman P, Treister R. · · 2021 · cited 5× · PMID 34307251 · DOI 10.3389/fped.2021.672324