Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001138875
Ethics application status
Approved
Date submitted
13/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Posture and its Effects on Health-Related Information Recall and Medication Attitudes
Scientific title
Posture and its Effects on Health-Related Information Recall and Medication Attitudes in Healthy Adults
Secondary ID [1] 304660 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor Cognitive Processing 322619 0
Medication Attitudes 322620 0
Negative mood 322626 0
Poor Posture 322981 0
Condition category
Condition code
Mental Health 320240 320240 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 320553 320553 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a randomised control trial that follows a 1:1 randomisation ratio.

The study is a single-centre study that will be conducted at the University of Auckland Grafton Clinical Centre. The study session is a one-off session that is expected to take approximately 30 to 40 minutes and is delivered by the co-investigator of the study. Participants will be allocated to either the group seated in a slumped posture or the group seated in an upright posture. The seating posture is manipulated by discretely altering the height of an iPad/ tablet tripod stand. The iPad/ tablet stand will be at a fixed height for all the participants in each condition. For participants in the upright posture group, the stand will be set 1.30 meters above the ground. For participants in the slumped posture, the stand will be set 0.65 meters above the ground. Those participants with a low height stand are expected to adopt a slumped posture to see the screen properly (intervention condition), whereas those with a high height stand are expected to adopt a more upright posture to see the screen (control condition). Participants will not know that there are two groups that have different height screens.

At the start of the session, participants will receive a brief introduction. They will be told that the study will investigate whether a video is a good way to tell patients about health and medical information. Participants will be asked permission to turn on a video camera (to record postural angles), which serves as a postural manipulation check. However, to maintain participant blindness, participants will be told that the video camera is set up to ensure that all the participants watch the full video and complete the questionnaires without being distracted (e.g. not using their mobile phone while watching the video).

Participants in both groups will first complete the demographic questionnaire and then
watch an 8-minute health information video. The video contains audio-recorded instructions
for the task and a brief introduction of what psoriasis is. The main content is a recording of a
mock consultation with Dr Paul Jarrett (Consultant dermatologist). The mock consultation explains a type of treatment recommended to treat severe psoriasis, along with the benefits, side effects of the treatment and how to take the medication. After the participants have watched the video, they will complete a series of online questionnaires. The design of the content of the video is partly based on a previous study showing that healthy participants have poor memory of information given about an anaesthetic (Sanderberg et al., 2012).
Intervention code [1] 321023 0
Behaviour
Comparator / control treatment
Active control group (the upright posture group is the active control group)
Control group
Active

Outcomes
Primary outcome [1] 328104 0
Positive and Negative health information recall assessed using a coding system designed using the transcript used for the video. This coding system has been used in past research and derived from Sanderberg et al. (2012).
Timepoint [1] 328104 0
Immediately after intervention
Secondary outcome [1] 397638 0
Expectations of the medication assessed by a composite of items adapted from the Beliefs about Medication Questionnaire-Specific scale (Horne et al., 1999) and from the Brief Illness Perception Questionnaire (Broadbent et al.,2006).
Items will be summed from both scales and Cronbach's alpha will be assessed for the scale reliability.
Timepoint [1] 397638 0
Immediately after intervention
Secondary outcome [2] 397639 0
Willingness to take medication assessed by items adapted from past research. The willingness scale was derived from Johnson et al.. (2009), which explored the effects engagement has on increasing patients’ willingness to take medication.
Timepoint [2] 397639 0
Immediately after intervention
Secondary outcome [3] 397641 0
Valence-Arousal state assessed with Visual Analogue Scales and the Linguistic Inquiry and Word Count text analysis program.
Timepoint [3] 397641 0
Immediately after intervention
Secondary outcome [4] 397659 0
Posture assessed by taking still frames from the video and measured using manual analysis (Protractor). The angles include the head, neck and shoulder.
Timepoint [4] 397659 0
4-time points

before demographic questionnaire (baseline)
during the video task at two minutes
during the video task three minutes
during follow-up questionnaire (2 minutes after viewing the video)
Secondary outcome [5] 398917 0
Confidence in taking medication assessed using the confidence scale adapted from the Treatment Satisfaction Questionnaire for Medication scale (Atkinson et al., 2004).
Timepoint [5] 398917 0
Immediately after intervention

Eligibility
Key inclusion criteria
The inclusion criteria for the study will be
(1) participants are able to understand, read and write/type in English
(2) participants are aged 16 or more.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for the study will be
(1) participants who have impaired vision or hearing that makes it difficult to use the computer or hear the researcher.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed Opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random online number generator on the computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted using G*Power (3.1.9.7) software to determine the necessary sample size, prior to recruitment (Faul et al., 2009). A systematic review and meta-analysis exploring the effect of expansive and contractive postures on affective and behavioural responses reported that all the combined self-reported outcomes reported a medium effect size (g equals .45) (Elkjær et al., 2020). Furthermore, research looking at the effects of posture on positive and negative recall found an effect size of n2 equals .12, which is a medium to large effect (Michalak et al., 2014). Using d equals .50 (a medium effect), choosing a power of .80 and an alpha of .05, a total sample of 128 people (64 participants per group) would be required to find a difference between two independent means between the postures (upright versus slumped) on positive and negative information recall. Given that the study is cross-sectional, there should no loss to follow-up, so the sample size will not need to be adjusted to compensate for attrition.

To analyse if the primary outcome, memory, is different between the two groups, independent t-tests will be conducted. To investigate whether there is a change in scores between the posture groups on the medication attitudes (positive and negative expectation, willingness, and confidence) independent t-tests will be conducted. To analyse if there is a difference between the valence-arousal state between the two groups, independent t-tests will be conducted. To analyse if valence-arousal effects mediate the relationship between posture and cognitive processing, a Sobel test will be conducted.
To analyse if the written responses between the two groups differed in the number of positive emotion words, negative emotion words, pronouns, and cognitive processing words, independent t-tests will be conducted. To analyse if the postural manipulation is maintained throughout the study, a mixed Analysis of Variance (ANOVA) (4 timepoints by 2 groups) will be conducted. Sensitivity analysis may be conducted based on measures of prior knowledge of the medication and condition (psoriasis).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 23932 0
New Zealand
State/province [1] 23932 0
Auckland

Funding & Sponsors
Funding source category [1] 309002 0
University
Name [1] 309002 0
The University of Auckland
Country [1] 309002 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 309966 0
None
Name [1] 309966 0
Address [1] 309966 0
Country [1] 309966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308892 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 308892 0
Ethics committee country [1] 308892 0
New Zealand
Date submitted for ethics approval [1] 308892 0
19/06/2021
Approval date [1] 308892 0
16/07/2021
Ethics approval number [1] 308892 0
AH22895

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

Contacts
Principal investigator
Name 112242 0
Prof Elizabeth Broadbent
Address 112242 0
Department of Psychological Medicine
The University of Auckland, Faculty of Medical and Health Sciences
Building 507
85 Park Road
Grafton
Auckland 1023
New Zealand.
Country 112242 0
New Zealand
Phone 112242 0
+64 9 923 6756
Fax 112242 0
Email 112242 0
[email protected]
Contact person for public queries
Name 112243 0
Elizabeth Broadbent
Address 112243 0
Department of Psychological Medicine
The University of Auckland, Faculty of Medical and Health Sciences
Building 507
85 Park Road
Grafton
Auckland 1023
New Zealand.
Country 112243 0
New Zealand
Phone 112243 0
+64 9 923 6756
Fax 112243 0
Email 112243 0
[email protected]
Contact person for scientific queries
Name 112244 0
Elizabeth Broadbent
Address 112244 0
Department of Psychological Medicine
The University of Auckland, Faculty of Medical and Health Sciences
Building 507
85 Park Road
Grafton
Auckland 1023
New Zealand.
Country 112244 0
New Zealand
Phone 112244 0
+64 9 923 6756
Fax 112244 0
Email 112244 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12359Study protocol    382296-(Uploaded-18-08-2021-13-03-53)-Study-related document.pdf
12360Informed consent form    382296-(Uploaded-30-06-2021-16-38-12)-Study-related document.pdf



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.