Clinical trial NCT04306679: Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
Official title: Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
First posted: 2020-03-13
Enrollment: 98
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. children at age 8-17 years;
2. absence of psychiatry, cognitive, and/or neurological disorders;
3. understand the purpose and the instructions of the study, agree to participate and parent signed inform consent.

Exclusion Criteria:

1. children suffering from Post traumatic stress disorder.

Primary outcomes:
measure: Quality of pain intensity scores based on the concordance between pain reports on different scales.
timeFrame: Pain intensity rating before analgesic consumption.
measure: Quality of pain intensity scores based on the concordance between pain reports on different scales.
timeFrame: Pain intensity rating one hour after analgesic consumption.
Secondary outcomes:
measure: The difference between children assessment vs. nurses assessment.
timeFrame: NPS ratings before and one hour after analgesic consumption
measure: The average difference between children assessment vs. parents.
timeFrame: NPS ratings before and one hour after analgesic consumption
measure: The average decrease in pain following analgesia: NPS
timeFrame: NPS ratings before and one hour after analgesic consumption
measure: Quality of pain intensity scores based on the concordance between pain reports on different scales.
timeFrame: Pain intensity ratings before analgesic consumption.
measure: Quality of pain intensity scores based on the concordance between pain reports on different scales.
timeFrame: Pain intensity ratings one hour after analgesic consumption.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa, The Clinical Pain Innovation Lab
Study officials:
References:
citation: Zontag D, Kuperman P, Honigman L, Treister R. Agreement between children's, nurses' and parents' pain intensity reports is stronger before than after analgesic consumption: Results from a post-operative study. Int J Nurs Stud. 2022 Jun;130:104176. doi: 10.1016/j.ijnurstu.2022.104176. Epub 2022 Jan 15.