Improvement of care during nurse-patient encounters for burn injuries in children by video interaction guidance

ISRCTN ISRCTN12850570
DOI https://doi.org/10.1186/ISRCTN12850570
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number MZH2011-28, project number: 1501
Sponsor Association of Dutch Burn Centres
Funder Nederlandse Brandwonden Stichting
Submission date
30/03/2022
Registration date
01/04/2022
Last edited
20/10/2023
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
Wound dressing changes are (daily) recurring nursing interventions in the treatment of paediatric patients with burns. An intervention that is painful and stressful for the child, and also for the nurse is an unwelcome but necessary act. It is thought that if nurses have more skills to interact with children during recurring medical events or nursing interventions, the events could be less distressing and painful for the children (Nillson et al., 2011). Video interaction guidance (VIG) has been applied to optimize the interaction between the nurse and the child. VIG is an intervention that builds positive relationships through filming and feedback sessions, micro-analysing interactions between the nurse and the child. The nurses find VIG a valuable and positive experience, but is there actually a change, improvement in interaction?

The study aims to investigate whether nurses’ interactional behaviour during recurring wound dressing changes can be improved by video interactive guidance and to check whether the interaction is associated with more comfort for the child.

Who can participate?
Nurses working in two Dutch burn centres for at least one year.

What does the study involve?
Participants will be randomly allocated to 2 or 3 VIG feedback sessions guided by a certified video-interactive guider (intervention group) or to work as usual (control group).
Before and after the intervention, 3 video recordings were made of nurse-child encounters in which wound dressings were changed. In the control group also 6 recordings per nurse were made. The videos were watched by a blinded observer to rate the interactional behaviour of nurses during wound dressing changes in children. In addition, child behaviour in all video recordings was scored by a blinded observer.

What are the possible benefits and risks of participating?
Possible benefits: enhancement of the fundamentals of care by improved relationships. There are no risks for nurses participating in this study.

Where is the study run from?
Association of Dutch Burn Centres (the Netherlands)

When is the study starting and how long is it expected to run for?
August 2012 to April 2018

Who is funding the study?
Dutch Burn Foundation (the Netherlands)

Who is the main contact?
Dr Anuschka Niemeijer, a.niemeijer@mzh.nl

Contact information

Dr Anuschka Niemeijer
Principal investigator

Association of Dutch Burn Centres
Zeestraat 27-2
Beverwijk
Z1940 EA
Netherlands

Phone +31(0)505245565
Email a.niemeijer@mzh.nl

Study information

Primary study designInterventional
Study designInterventional randomized controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImprovement of care during nurse-patient encounters for burn injuries in children by video interaction guidance: a randomized controlled trial of effectiveness
Study acronymICVIG
Study objectivesThis study examines whether Video Interactive Guidance (VIG) is a useful tool to improve the nurses’ professional relationships during nurse-patient encounters and whether better interaction is associated with more comfort as experienced by patients.
Ethics approval(s)1. Approved 11/09/2012, Medical ethics committee (Martini Hospital, van Swietenplein 1, 9728NT Groningen, The Netherlands; +31 (0)505246311; MEC@mzh.nl), ref: 2011-28
2. Approved 19/01/2016, Medical ethics committee (Maasstad Hospital Maasstadweg 21, 3079DZ Rotterdam, The Netherlands; +31(0)102913216; kLeistraM@maasstad.nl), ref: L2015-088
Health condition(s) or problem(s) studiedInteraction between the nurse and child with burns during woundcare.
InterventionIn total 17 burn care nurses were randomized into two groups: an intervention group (7 nurses) and a control group. The intervention group received 2 or 3 VIG feedback sessions guided by a certified video-interactive guider. Before and after the intervention, 3 video recordings were made of nurse-child encounters in which wound dressings were changed. In the control group also 6 recordings per nurse were made. Both nurses and parents of the children were asked for informed consent. The videos were watched by a blinded observer. The observer scored the recorded wound dressing changes using the nurse-child interaction taxonomy (NCIT) for interactional behaviour of nurses during wound dressing changes in children (16 items scored on a 7 point scale). In addition, child behaviour in all video-recordings (n=102) was scored with the Comfort-B scale by a blinded observer.

Selection of nurses and allocation to the VIG and no-VIG group was performed by someone not involved in data acquisition. For the selection of participants, a computer randomised generated list was used and computerised coin flipping for the allocation (http://www.random.org).

Rating of outcome measures started after all tapes during nursing were made. All tapes were blinded, i.e. their sequence could not be identified by the raters. Furthermore, the raters did not know which of the nurses received VIG. An experienced, independent third rater scored all tapes regarding pain and discomfort using the COMFORT-B scale. This rater was also blinded for allocation.
Intervention typeBehavioural
Primary outcome measure(s)

Nurses’ skills to interact with their patients are measured with the Nurse-Child Interaction Taxonomy (NCIT, van Ingen Schenau-Veldman et al., 2020) before and after the intervention. Videotapes of wound dressing changes are systematically scored using the NCIT. The NCIT was specially developed to score the interaction between nurses and children with burns during wound dressing changes.

Key secondary outcome measure(s)

The intensity of pain and distress experienced by the child is measured using the COMFORT behaviour scale (COMFORT-B) at the time of care encounter by a blinded observer.

Completion date20/04/2018

Eligibility

Participant type(s)Health professional
Age groupAdult
SexAll
Target sample size at registration17
Total final enrolment17
Key inclusion criteriaNurses with at least one year of experience working in our burn centres
Key exclusion criteriaNurses with less than one year of experience
Date of first enrolment06/12/2012
Date of final enrolment01/02/2016

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Martini Hospital
van Swietenplein 1
Groningen
9728 NT
Netherlands
Maasstad Hospital
Maasstadweg 21
Rotterdam
3079 DZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
IPD sharing planThis data can be obtained on request.
ingensa@mzh.nl

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 23/02/2023 20/10/2023 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

20/10/2023: Publication reference added.
01/04/2022: Trial's existence confirmed by Medical ethics committee of Martini Hospital.