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NCT Number: NCT04306679

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

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.

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Key information

Conditions

Surgery

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa, The Clinical Pain Innovation Lab

Haifa, 3498838, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • children suffering from Post traumatic stress disorder.

Treatment and study plan

Animation clips

Other

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

Instructions

Other

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

Primary outcomes

  1. Quality of pain intensity scores based on the concordance between pain reports on different scales.

    Time frame: 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.

  2. Quality of pain intensity scores based on the concordance between pain reports on different scales.

    Time frame: Pain intensity rating one hour after 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 outcomes

  1. The difference between children assessment vs. nurses assessment.

    Time frame: NPS ratings before and one hour after analgesic consumption

    The 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."

  2. The average difference between children assessment vs. parents.

    Time frame: NPS ratings before and one hour after analgesic consumption

    The 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."

  3. The average decrease in pain following analgesia: NPS

    Time frame: NPS ratings before and one hour after analgesic consumption

    The 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."

  4. Quality of pain intensity scores based on the concordance between pain reports on different scales.

    Time frame: 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.

  5. Quality of pain intensity scores based on the concordance between pain reports on different scales.

    Time frame: Pain intensity ratings one hour after 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Rambam Health Care Campus

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2020
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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