SurgeryNCT04306679
Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
A study testing Animation clips and Instructions in people with Surgery, run by University of Haifa at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Animation clips and Instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jun 2019to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 1. children suffering from Post traumatic stress disorder.
Trial locations and contacts
1 site in 1 country.
Israel1 site
University of Haifa, The Clinical Pain Innovation Lab
Haifa, 3498838
About this study
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.
Read more
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
- Being tested
- Animation clips, Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation clipsOther
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
InstructionsOther
Routine preoperative preparations, which included a section on pain assessment instructions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Animation clips |
| Control | Other | Children underwent the routine pre-operative preparations, which included a section on pain assessment. Receives: Other: Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pain intensity rating one hour after analgesic consumption.
Secondary outcomes (5)
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."
Measured: NPS ratings before and one hour after analgesic consumption
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."
Measured: NPS ratings before and one hour after analgesic consumption
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."
Measured: NPS ratings before and one hour after analgesic consumption
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.
Measured: Pain intensity ratings before analgesic consumption.
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.
Measured: Pain intensity ratings one hour after analgesic consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start20 Jun 2019
- Primary completion20 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306679
- Sponsor's protocol ID
- 0091-19-RMB
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35395574
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
- ClinicalTrials.gov ID
- NCT04306679
- Acronym / sponsor ID
- 0091-19-RMB
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: Animation clipsThe 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. |
| Control | Other | Other: InstructionsChildren underwent the routine pre-operative preparations, which included a section on pain assessment. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. children suffering from Post traumatic stress disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation clipsThe 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 | Other | Interventional arm |
| InstructionsRoutine preoperative preparations, which included a section on pain assessment instructions. | Other | Control |
Primary outcome
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.
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.
5 secondary outcomes
The difference between children assessment vs. nurses assessment.
Time frame: NPS ratings before and one hour after analgesic consumption
The average difference between children assessment vs. parents.
Time frame: NPS ratings before and one hour after analgesic consumption
The average decrease in pain following analgesia: NPS
Time frame: NPS ratings before and one hour after analgesic consumption
Quality of pain intensity scores based on the concordance between pain reports on different scales.
Time frame: Pain intensity ratings before analgesic consumption.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 35395574Zontag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation clips and Instructions in people with Surgery, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of pain intensity scores based on the concordance between pain reports on different scales. (time frame: Pain intensity rating before analgesic consumption.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.