Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000706471
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
27/05/2016
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a child-focussed, incentive and educational resource kit (‘Up and Go Goodie Bag’) on encouraging early upright mobilisation in children post abdominal surgery.
Scientific title
The effect of a child-focussed, incentive and educational resource kit (‘Up and Go Goodie Bag’) compared with current care on encouraging early upright mobilisation and preventing post operative pulmonary complications in children aged 9-12 years of age who have undergone abdominal surgery.
Secondary ID [1] 286014 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative pulmonary complications 293977 0
Condition category
Condition code
Respiratory 294277 294277 0 0
Other respiratory disorders / diseases
Surgery 294340 294340 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (Up and Go Goodie Bag)
The "Up and Go" Goodie Bag will include child-friendly age appropriate information on the benefits of early upright mobilization and breathing exercises in the post-operative period. The information will include instruction on how to perform the breathing exercise routine and how to perform supported coughing. Incentives to encourage these exercises will include the provision of age appropriate toys such as whistles and bubble blowers. Incentives to encourage upright mobilization and completion of breathing exercises will include sticker charts with rewards for reaching goal points. Consumers, including the youth advisory committee of PMH will be consulted about the presentation of the information and contents of the Up and Go Goodie Bag.

The goodie bag is administered day 0, i.e., day of the surgery, but post operatively on the day of the surgery. The goodie bags, activities and incentives cover the first 5 days post operatively until discharge. The minimum recommended frequency would be ten deep breaths (ie one breathing exercises/activity) per hour that the child is awake or one period of upright mobilisation, which includes sitting out of bed, or assisted walking per hour the child is awake. The time of upright mobilsation is dependent on recovery stage i.e., day post op with increasing time expected as days progress. The frequency of breathing exercises and upright time are outcomes being assessed within this trial to determine recommended recommended protocols as there is currently no good data of what to recommend for children. Parental support to initiate and complete activities is required. It is anticipated that older aged children (10-12 year old) may show self initiation but this is uncertain.
Intervention code [1] 290992 0
Treatment: Other
Intervention code [2] 291045 0
Behaviour
Comparator / control treatment
The control group will receive current, standard medical, nursing and physiotherapy care. Curent standard care includes nursing general observation including pain assessments and referral for physiotherapy from medical staff as they see appropriate.
Control group
Active

Outcomes
Primary outcome [1] 294070 0
Intensity and frequency of mobilization measured using positional activity logger (PAL 2) on a daily basis for the first 5 days including:
Uptime duration (minutes),
Maximal single upright period (minutes),
Sit-to-stand frequency (counts)
The PAL 2 is a modified version of the Uptimer, which has been shown to be a reliable and valid method of recording uptime in adults and children post abdominal surgery (Browning et al 2007; Eldridge et al 2003). The PAL 2 records the quantity of time spent in an upright position – termed uptime. The device is worn on the thigh and senses changes in position via three mercury tilt switches. Data are downloaded and analysed.
Timepoint [1] 294070 0
Daily for the first 5 days post operatively or until discharge if this time is shorter.
Primary outcome [2] 294072 0
Length of stay
Timepoint [2] 294072 0
Total inpatient days from day 0 post operative to discharge.
Secondary outcome [1] 312465 0
Subjective evaluation of pain levels (Likert Pain scales or Faces Pain Scale)
A numerical Likert rating scale will measure pain intensity in children aged 8-12years. Participants will be asked to verbally rate the intensity of pain on a scale from "0" (no pain) to "'10" (worst pain possible; most hurt possible). Numerical rating scales have been shown to be valid, reliable and to have good sensitivity to change in perceived pain in children post operatively as young as 8 years of age (Page et al 2008).
For children aged 4-8 years the Faces Pain Scale will be used to measure pain intensity. The Faces Pain Scale is a visual scale composed of six faces illustrating increasing levels of pain intensity. Children are asked to choose the face that best describes the intensity of the pain they are currently experiencing. Scores range from 0 to 10 with the faces representing the lower and higher levels of pain intensity coded as 0 and 10, respectively. The Faces Pain Scale is highly correlated with the visual analogue scale (r =.93) showing good validity (Hicks et al 2003).
Timepoint [1] 312465 0
Daily from Day 0 post operatively to discharge.
Secondary outcome [2] 312466 0
Development of post op pulmonary complications
Postoperative pulmonary complications will be defined as when there are four or more of the eight criteria as defined by Scholes et al, 2009. While there is no consensus about the best tool to use in diagnosing post operative pulmonary complications in abdominal surgery, particularly children, these criteria were selected on the basis that they are the most recently described and have been used in recent Australian studies in adult populations (Scholes et al 2009; Haines et al 2013).
Timepoint [2] 312466 0
Daily from day 0 post operatively to discharge.
Secondary outcome [3] 312467 0
Gut motility which is assesses by the number of days to oral feed tolerance.
Clinical studies on post-surgical gastrointestinal motility have used indicators such as the occurrence of the first flatus, the time required to resume oral intake, or the recovery of bowel sounds (Nakayoshi et al 2008).
Timepoint [3] 312467 0
Time to first oral intake post operatively.
Secondary outcome [4] 312468 0
Referrals to physiotherapy, reason for referral and physiotherapy occasions of service
Timepoint [4] 312468 0
Daily from day 0 post operative to discharge.
Secondary outcome [5] 312469 0
Medical/Nursing staff perceived efficacy of Up and Go Goodie bag utising a survey which will be specifically developed for this trial.
Timepoint [5] 312469 0
End of trial period.

Eligibility
Key inclusion criteria
Patients undergoing abdominal surgery (open or laparoscopic, upper or lower)
Child or parent able to understand simple age-appropriate written English
Admitted to Ward 5C (surgical ward)
Return to the ward (5C ) the day of their surgery.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Post operative order request for rest in bed for greater than 24 hours.
Patients who return for further surgery within the first 4 post operative days
Patients with any pre-existing, tertiary hospital managed respiratory condition other than asthma
Non-ambulant patients (eg. children with Cerebral Palsy GMFCS level IV and V)
Patients operated on Saturday or Sunday
Inability to understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Design: Quasi Experimental Before and After Study Design
A “before and after” study design will be used. The “before” period (control phase) will enrol consecutive patients who have undergone abdominal surgery before Up and Go Goodie Bag implementation (intervention). These control group participants will receive standard medical/nursing care which includes encouragement of early mobilization and referral for physiotherapy only on medical request.

The “after” period (intervention phase) involves enrolment of consecutive patients who have undergone abdominal surgery and who will receive standard medical/nursing care as well as being supplied on day 0 with an Up and Go Goodie bag designed to encourage early mobilization and deep breathing exercises. They will also receive a referral for chest physiotherapy only on medical request.

It is not possible to have a randomised controlled study design as it is difficult to have subjects in a shared room or ward visibly receiving different management approaches at the same time. Nursing care would be influenced by the intervention and the trial results would be confounded

Control Phase
Participants will be recruited sequentially on arrival to the ward after an abdominal surgical procedure. Families will be provided with an informed consent sheet. These participants in the control period will receive current standard care, including encouragement and assistance from nursing staff to mobilise, and referrals to physiotherapy by medical staff as required.

Up right time of participants in this control phase will be measured using the Positional Activity Logger 2 (PAL 2). A research assistant will apply the PAL2 to recruited participants and educate them on its required use. The PAL2 will be checked daily by the research assist to ensure that continuous data recording is occurring and monitor participant compliance with its wear. The PAL2 is worn for 24 hours a day for five consecutive days including showering/bathing. It will be removed on the day of discharge. If the participant is discharged prior to Day 5, the PAL 2 will be removed on the morning of discharge. If the PAL 2 is dislodged, inadvertently removed, or ceased to record, only full day data from the correctly worn activity logger will be used. Following discharge, the research assistance will collate data regarding patient demographics, surgical history, PMH, gut motility, evidence of PPC and referral history to Physiotherapy.


Intervention Phase
During the intervention phase, nursing staff will be asked to distribute the Up and Go Goodie Bags to participants recruited in the trial on their first day on the ward. The Research Assistant will monitor adherence and will award incentive prizes when uptime is achieved and goals are reached. The Research Assistant will supply participants with the PAL2 on arrival to the ward and collect data as described in the Control Phase.

Intensity and frequency of mobilization measured using positional activity logger (PAL 2) on a daily basis for the first 5 days including:
Uptime duration (minutes),
Maximal single upright period (minutes),
Sit-to-stand frequency (counts)
The PAL 2 is a modified version of the Uptimer, which has been shown to be a reliable and valid method of recording uptime in adults and children post abdominal surgery (Browning et al 2007; Eldridge et al 2003). The PAL 2 records the quantity of time spent in an upright position – termed uptime. The device is worn on the thigh and senses changes in position via three mercury tilt switches. Data are downloaded and analysed.

Subjective evaluation of pain levels (Likert Pain scales or Faces Pain Scale)
A numerical Likert rating scale will measure pain intensity in children aged 8-12years. Participants will be asked to verbally rate the intensity of pain on a scale from "0" (no pain) to "'10" (worst pain possible; most hurt possible). Numerical rating scales have been shown to be valid, reliable and to have good sensitivity to change in perceived pain in children post operatively as young as 8 years of age (Page et al 2012).

For children aged 4-8 years the Faces Pain Scale will be used to measure pain intensity. The Faces Pain Scale is a visual scale composed of six faces illustrating increasing levels of pain intensity. Children are asked to choose the face that best describes the intensity of the pain they are currently experiencing. Scores range from 0 to 10 with the faces representing the lower and higher levels of pain intensity coded as 0 and 10, respectively. The Faces Pain Scale is highly correlated with the visual analogue scale (r =.93) showing good validity (Hicks et al 2003).

Development of post op pulmonary complications
Postoperative pulmonary complications will be defined as when there are four or more of the eight criteria as defined by Scholes et al, 2009. While there is no consensus about the best tool to use in diagnosing post operative pulmonary complications in abdominal surgery, particularly children, these criteria were selected on the basis that they are the most recently described and have been used in recent Australian studies in adult populations (Scholes et al 2009; Haines et al 2013).

Gut motility which is assesses by the number of days to oral feed tolerance.
Clinical studies on post-surgical gastrointestinal motility have used indicators such as the occurrence of the first flatus, the time required to resume oral intake, or the recovery of bowel sounds (Nakayoshi et al 2008).

At the end of the trial medical/rursing staff perceived efficacy of Up and Go Goodie bag utising a survey which will be specifically developed for this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
two group, sequential enrolment
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/05/2016
Actual
Date of last participant enrolment
Anticipated
1/09/2018
Actual
Date of last data collection
Anticipated
1/11/2018
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7906 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 15868 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 290607 0
Charities/Societies/Foundations
Name [1] 290607 0
PMH Foundation
Baron-Hay Grant
Country [1] 290607 0
Australia
Primary sponsor type
Hospital
Name
Princess MArgaret Hospital
Address
GPO BOX D184
Perth WA 6840
Country
Australia
Secondary sponsor category [1] 289293 0
None
Name [1] 289293 0
Address [1] 289293 0
Country [1] 289293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292238 0
Princess Margaret Hospital
Ethics committee address [1] 292238 0
Ethics committee country [1] 292238 0
Australia
Date submitted for ethics approval [1] 292238 0
06/01/2015
Approval date [1] 292238 0
04/12/2015
Ethics approval number [1] 292238 0
2015006EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54254 0
Ms Julie Depiazzi
Address 54254 0
Princess Margaret Hospital
Department of Physiotherapy
GPO BOX D184
Perth WA 6840
Country 54254 0
Australia
Phone 54254 0
61 8 9340 8503
Fax 54254 0
Email 54254 0
[email protected]
Contact person for public queries
Name 54255 0
Julie Depiazzi
Address 54255 0
Princess Margaret Hospital
Department of Physiotherapy
GPO BOX D184
Perth WA 6840
Country 54255 0
Australia
Phone 54255 0
61 8 9340 8503
Fax 54255 0
Email 54255 0
[email protected]
Contact person for scientific queries
Name 54256 0
Noula Gibson
Address 54256 0
Princess Margaret Hospital
Department of Physiotherapy
GPO BOX D184
Perth WA 6840
Country 54256 0
Australia
Phone 54256 0
61 8 9340 8503
Fax 54256 0
Email 54256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.