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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306679
• Other study ID #: 0091-19-RMB
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: March 2020
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 21, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Animation 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
• Instructions
Routine preoperative preparations, which included a section on pain assessment instructions.

Locations

Country	Name	City	State
Israel	University of Haifa, The Clinical Pain Innovation Lab	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	The difference between children assessment vs. nurses assessment.	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."	NPS ratings before and one hour after analgesic consumption
Secondary	The average difference between children assessment vs. parents.	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."	NPS ratings before and one hour after analgesic consumption
Secondary	The average decrease in pain following analgesia: NPS	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."	NPS ratings before and one hour after analgesic consumption
Secondary	Quality of pain intensity scores based on the concordance between pain reports on different scales.	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.	Pain intensity ratings before analgesic consumption.
Secondary	Quality of pain intensity scores based on the concordance between pain reports on different scales.	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.	Pain intensity ratings one hour after analgesic consumption.