Condition category
Mental and Behavioural Disorders
Date applied
02/04/2010
Date assigned
18/05/2010
Last edited
18/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Johan Berghmans

ORCID ID

Contact details

Lindendreef 1
Antwerp
2020
Belgium
+32 (0)3 280 3995
johan.berghmans@zna.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AR001

Study information

Scientific title

Evaluation of the influence of audiovisual information on the anxiety and contentement of the parent present during the induction of anaesthesia on children

Acronym

Anredaud

Study hypothesis

Offering audiovisual information may influence pre-operative and post-operative state anxiety of the parents of a child undergoing surgery.

Ethics approval

Medical Research Ethics Committee (MREC) - Ziekenhuisnetwerk Antwerpen (ZNA) approved on the 10th February 2010 (ref: 3541)

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anxiety reduction

Intervention

This is randomised double-blind research in which 120 parents will take part who will accompany the child to the operating room. After filling out the admission form, we collect the following demographic data of the parents and the child: the age, gender of the parent present, the parent's native language, type of surgery, whether or not it is the first surgery the child undergoes, if the parents have other children who have undergone surgery, the highest qualification of the parents and if there has been a prior consultation between the parents and the anaesthetist (this will take 5 minutes).

All parents receive standard written information about what the anaesthesia implies and what will precisely happen at the induction. No premedication is given. During the whole course, a voluntary worker will be present.

At admission (the day of the surgery), the parents and their child are randomised in a control group and an intervention group. We are going to use blind-numbered envelopes to do this. This randomisation will be carried out using computer generated numbers. Men as well as women will be included in this.

After that, we will verify the anxiety score of the parent present. We will use the State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS), the latter also questions the need for information. Every parent present will also be asked to fill in the two questionnaires. This will take approximately 10 minutes.

The intervention group will then receive audiovisual information, in the form of a short movie (duration: 4 minutes), the control group does not see the movie. This movie will describe the hospitalisation, the transport to the operating room, the induction and the induction of the anaesthesia by telling a story about the journey of young boy to "Groenland" (Greenland), a metaphor for our operating room, together with his friend "Mister Dragon". During the journey, the young boy meets Caroline and together with his mum he arrives in Groenland. The movie was shot at the Koningin Paola Kinderziekenhuis.

After this, we will ask the both parental groups to fill in the state-part of the STAI (Spielberger) and the APAIS again (this will take approximately 4 minutes). After this, the child and the parent present will be guided to the operating room.

During the induction, the anaesthetist fills in the Induction Compliance Checklist (ICC) and the Visual Analogue Scale (VAS). The anaesthetist does not know to which group the parent has been allocated.

The ICC is developed to score the child’s behaviour during the induction of anaesthesia. The list consists of 11 items indicating the level obligingness of the child at induction. The total score = the amount of categories checked (perfect score = 0).

The VAS is a 100 mm horizontal line with two behavioural extremes (not anxious to very anxious) on both ends. The anaesthetist marks how anxious the child is during induction.

After the induction of the anaesthesia on the child, the parent and the voluntary worker leave the operating room. All parents are asked to fill in the state anxiety part of the STAI (Spielberger) and the APAIS again (duration: 4 minutes).

All accompanying parents will also be asked to fill in a short additional questionnaire which will assess the general satisfaction level, the quality of the provided preoperative information and the benefit of the provided audiovisual information (intervention group only). We use a VAS scale for which the parent is asked to put a mark between the two extremes.

The questions are:
1. Were you satisfied about the given information in connection to the anaesthesia? (absolutely not to very satisfied)
2. Were you very motivated to be present at the induction of anaesthesia? (not to absolutely want to be present)
3. Do you believe that your presence is useful for your child? (not useful to absolutely necessary)
4. Are you satisfied with the course of the procedure? (totally not to very satisfied)
5. Do you think that giving audiovisual information is useful for the preparation of anaesthesia? (intervention group only) (totally not to very useful)

The anxiety which the child has experienced according to the parent during the induction is also measured by means of a VAS scale. As previously discussed, the VAS scale is a 100 mm horizontal line with two behavioural extremes (not anxious to very anxious) which are on either side of the scale. The parent present marks the level of anxiety during induction of the child.

6. How anxious was your child according during the induction? (totally not anxious to very anxious)

This will take an additional 5 minutes. The total duration to fill in the questionnaires in both arms (intervention and control) will be 28 minutes. The intervention group will see the audiovisual information (short movie) which will take another 4 minutes, therefore the total duration of treatment in the control group will be 28 minutes and the total duration of treatment in the intervention group will be 32 minutes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

State anxiety reduction reduction (STAI Spielberger and APAIS), measured at admission (T1), after viewing (or not) the audiovisual information (T2) just before entering the operating theatre and when the parents leave the operating theatre (T3).

Secondary outcome measures

1. Correlation between state anxiety and trait anxiety (STAI Spielberger), measured at admission (T1), after viewing (or not) the audiovisual information (T2) just before entering the operating theatre and when the parents leave the operating theatre (T3)
2. Correlation between need for information (information part of the APAIS) and the state/trait anxiety (state part of APAIS and STAI Spielberger), measured at admission (T1)
3. Correlation between Induction Compliance Checklist (ICC) and anxiety measure of the child at induction by using a VAS. Both measurements are done after induction by the anaesthetist (Tafter induction anaesthetist).
4. Anxiety measure of the child (by the parent) at induction by using a VAS. This will be done after induction by the parent, when the parent has left the operating theatre (Tafter induction parent). Correlation will be sought between VAS (Tafter induction parent) and the ICC (Tafter induction Anaesthetist).
5. Satisfaction measurement of the parents by using a VAS (Tafter induction parent)

Overall trial start date

15/02/2010

Overall trial end date

01/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged older than 6 months, either sex
2. Written consent ('Informed Consent')
3. Parents who understand and speak Dutch
4. Parent present at induction
5. No premedication
6. Parent of a child undergoing surgery in a daycentre
7. American Society of Anaesthesiologists classification (ASA) 1 - 2 and 3

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Not understanding/speaking Dutch
2. No consent for the research
3. Children younger than 6 months

Recruitment start date

15/02/2010

Recruitment end date

01/08/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Lindendreef 1
Antwerp
2020
Belgium

Sponsor information

Organisation

ZNA Middelheim - Queen Paola Children’s Hospital (Belgium)

Sponsor details

Lindendreef 1
Antwerp
2020
Belgium
johan.berghmans@zna.be

Sponsor type

Hospital/treatment centre

Website

http://www.zna.be

Funders

Funder type

Hospital/treatment centre

Funder name

ZNA Middelheim - Queen Paola Children’s Hospital (Belgium) - Department of Anaesthesia and Reanimation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes