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

NCT04306679 | Completed

• 1 other identifier: 0091-19-RMB
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

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

  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.

  Pain intensity rating before analgesic consumption.

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

  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.

  Pain intensity rating one hour after analgesic consumption.

Secondary Outcomes (5)

• The difference between children assessment vs. nurses assessment.

  NPS ratings before and one hour after analgesic consumption

• The average difference between children assessment vs. parents.

  NPS ratings before and one hour after analgesic consumption

• The average decrease in pain following analgesia: NPS

  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 before 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.

Study Arms (2)

Interventional arm

EXPERIMENTAL

The intervention, which was aimed to educate children on how to use pain scales and provide reliable pain assessments was based on a two short animation clips, lasting approximately 5 min each, and a short (5 min) guided interaction between the study nurse and the participants, in between the two clips.

Other: Animation clips

Control

OTHER

Children underwent the routine pre-operative preparations, which included a section on pain assessment.

Other: Instructions

Interventions

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

Interventional arm

Instructions OTHER

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

Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. children suffering from Post traumatic stress disorder.

Sponsors & Collaborators

• University of Haifa: lead
• Rambam Health Care Campus: collaborator

Study Sites (1)

University of Haifa, The Clinical Pain Innovation Lab

Haifa, 3498838, Israel

Location

Related Publications (1)

• 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.

  PMID: 35395574 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 13, 2020
• Study Start: June 20, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 21, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)