Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306679
Enrollment
98
Registered
2020-03-13
Start date
2019-06-20
Completion date
2019-11-21
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

Routine preoperative preparations, which included a section on pain assessment instructions.

OTHERAnimation clips

The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies

Sponsors

Rambam Health Care Campus
CollaboratorOTHER
University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of pain intensity scores based on the concordance between pain reports on different scales.Pain intensity rating before analgesic consumption.The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values. The average difference of the 6 pairs was calculated. The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.

Secondary

MeasureTime frameDescription
The difference between children assessment vs. nurses assessment.NPS ratings before and one hour after analgesic consumptionThe difference between children pain assessment vs. nurses assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates no pain and 10 the worst pain imaginable.
The average difference between children assessment vs. parents.NPS ratings before and one hour after analgesic consumptionThe difference between children pain assessment vs. parents assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates no pain and 10 the worst pain imaginable.
The average decrease in pain following analgesia: NPSNPS ratings before and one hour after analgesic consumptionThe average decrease in pain following analgesic consumption (Delta NPS) based on a 0-10 numerical pain scale (NPS), in which 0 indicates no pain and 10 the worst pain imaginable.
Quality of pain intensity scores based on the concordance between pain reports on different scales.Pain intensity ratings before analgesic consumption.The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment). To assure that variability will be appropriately reflected by this measure, subjects who reported only 0 or only 10 in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026