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

NCT ID: NCT04306679

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2019-11-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional arm

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.

Group Type: EXPERIMENTAL

Animation clips

Intervention Type: 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

Control

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

Group Type: OTHER

Instructions

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Instructions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Haifa, The Clinical Pain Innovation Lab

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 35395574 (View on PubMed)

Other Identifiers

0091-19-RMB

Identifier Type: -

Identifier Source: org_study_id