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Clinical Trials/NCT04306679
NCT04306679
Completed
Not Applicable

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

University of Haifa1 site in 1 country98 target enrollmentJune 20, 2019
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
University of Haifa
Enrollment
98
Locations
1
Primary Endpoint
Quality of pain intensity scores based on the concordance between pain reports on different scales.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2019
End Date
November 21, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • The average difference between children assessment vs. parents.(NPS ratings before and one hour after analgesic consumption)
  • The difference between children assessment vs. nurses assessment.(NPS ratings before and one hour after analgesic consumption)
  • Quality of pain intensity scores based on the concordance between pain reports on different scales.(Pain intensity ratings one hour after analgesic consumption.)
  • The average decrease in pain following analgesia: NPS(NPS ratings before and one hour after analgesic consumption)

Study Sites (1)

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