Testing the Dutch version of the Parents’ Postoperative Pain Measure (PPPM)

ISRCTN	ISRCTN12813822
DOI	https://doi.org/10.1186/ISRCTN12813822
Secondary identifying numbers	E.C. 5394

Submission date: 21/10/2020
Registration date: 22/10/2020
Last edited: 22/01/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims.
More and more operations in children take place in an outpatient setting (no overnight stay in hospital). Consequently, parents at home play an increasingly important role in the postoperative care of their child.
An essential part of this care is to recognize and treat pain, which is not always evident in children because they also show certain behavioral changes after an operation. Queen Paola Children’s Hospital is currently conducting research into these behavioral changes in children after an operation and pain measurements by parents.

Who can participate?
Children between 2 and 12 years old who will undergo an outpatient operation.

What does the study involve?
Prior to the operation parents fill in a questionnaire concerning their child’s behavior.
Once back home after the operation the parent will keep a diary for five days, in which the behavioral changes of the child are scored twice a day (in the morning after breakfast and in the evening after supper).
If the child is older than 6, they will be provided with a diary to indicate a pain score by means of a face scale twice a day done at the same time as the parent diary.

What are the possible benefits and risks of participating?
None

Where is the study run from?
ZNA Middelheim - Queen Paola Children’s hospital (Belgium)

When is the study starting and how long is it expected to run for?
December 2019 to February 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Johan Berghmans, johan.berghmans@zna.be

Contact information

Dr Johan Berghmans
Scientific

Wijerveldstraat 69
Hasselt
3500
Belgium

ORCID ID	0000-0002-3835-562X
Phone	+32 (0)478496755
Email	johan.berghmans@zna.be

Study information

Study design	Single-centre prospective observational study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	The Dutch version of the Parents’ Postoperative Pain Measure (PPPM) – validity and reliability in the assessment of postoperative pain among children aged between 2 and 12 years
Study acronym	PPPM-D-form
Study objectives	To establish the reliability, validity, and sensitivity to change overtime (longitudinal sensitivity) of the Dutch version of the Parents’ Postoperative Pain Measure (PPPM-D) in the assessment of postoperative pain among children aged between 2 and 12 years.
Ethics approval(s)	Approved 08/07/2020, Commissie voor Medische Ethiek ZNA, Institutional Review Board (ZNA/OCMW Antwerpen, Lindendreef 1, 2020 Antwerpen, Belgium; +32(0)32803429; ), ref: 009;OG 031; E.C. 5394
Health condition(s) or problem(s) studied	Assessment of postoperative pain
Intervention	A formal forward-back-forward translation procedure to translate the PPPM into Dutch (PPPM-D) will be carried out. Furthermore an expert panel of two psychologists and two anesthesiologists will evaluate the translation. This prospective observational study aims to include 120 children stratified according to: 1. Child’s age - age between 2-5 and between 6- 12 years of age (dichotomy based on the child’s ability to self-report of pain intensity by using the Faces Pain Scale Revised – FPS-R) 2. Different kinds of surgery (general, orthopedic, urologic, maxillofacial and otolaryngologic) related to the expected level of postoperative pain intensity levels (mild, moderate, severe). After receiving precise instructions one accompanying parent will complete the PPPM-D at the day of surgery (before the intervention) and directly after surgery in the evening and this parent will later rate the child’s pain twice a day (morning-evening) during the first 5 postoperative days. In parallel with the PPPM assessments, parents will also use a Numerical Rating Scale (NRS) to assess the pain of their child. Also, children between 6 and 12 years will rate their pain intensity twice a day during 5 days postoperative by using the Faces Pain Scale Revised (FPS-R).
Intervention type	Other
Primary outcome measure	Pain measured using the Dutch version of Parents’ Postoperative Pain Measure (PPPM-D) two times each day by parents (after breakfast and in the evening after dinner) during five consecutive days. Parents will also fill in the PPPM-D on the day of surgery before the intervention as basic assessment
Secondary outcome measures	1. Pain measured using a Numerical Rating Scale (NRS-11) two times each day by parents (after breakfast and in the evening after dinner) during five consecutive days. Parents will also fill in the NRS on the day of surgery before the intervention as basic assessment 2. Pain measured using the Faces Pain Scale-Revised (FPS-R) two times each day during 5 postoperative days (self report by the children)
Overall study start date	01/12/2019
Completion date	28/02/2023

Eligibility

Participant type(s)	Mixed
Age group	Child
Lower age limit	2 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	120
Total final enrolment	120
Key inclusion criteria	1. Children 2 – 12 years old 2. Information and consent forms for parents and an assent form explained to the child 3. Undergoing one of the following surgical procedures: inguinal hernia repair, myringotomy, adenoidectomy, gastroscopy, dental surgery, orchidopexy, strabismus, circumcision, adenotonsillectomy, orthopedic osteosyntheses 4. One accompanying parent present at induction 5. Parents who speak and understand Dutch 6. No premedication
Key exclusion criteria	1. Known mental/cognitive retardation 2. American Society Anesthesiologists ASA physical status >II
Date of first enrolment	01/11/2020
Date of final enrolment	31/08/2022

Locations

Countries of recruitment

Belgium

Study participating centre

ZNA Middelheim - Queen Paola Children's Hospital

Lindendreef 1
Antwerpen
2020
Belgium

Sponsor information

ZNA Middelheim Hospital
Hospital/treatment centre

Lindendreef 1
Antwerpen
2020
Belgium

Phone	+32 (0)32803993
Email	stefaan.goossens@zna.be
Website	http://zna.be
"ROR"	https://ror.org/01z5jvj74

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	28/07/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in high-impact peer-reviewed journal.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v1.0	26/05/2020	06/11/2020	No	No
Results article			22/01/2024	Yes	No

Additional files

ISRCTN12813822_PROTOCOL_v1.0_26May2020.pdf: uploaded 06/11/2020

Editorial Notes

22/01/2024: Publication reference added.
13/02/2023: The intention to publish date was changed from 28/02/2023 to 28/07/2023.
24/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/11/2022 to 28/02/2023.
2. The intention to publish date was changed from 30/12/2021 to 28/02/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
13/04/2022: The recruitment end date has been changed from 30/04/2022 to 31/08/2022.
14/12/2021: The recruitment end date was changed from 01/12/2021 to 30/04/2022.
06/11/2020: Uploaded protocol (not peer reviewed) Version 1.0, 26 May 2020.
22/10/2020: Trial’s existence confirmed by Commissie voor Medische Ethiek ZNA