Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000314628
Ethics application status
Approved
Date submitted
14/03/2023
Date registered
23/03/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
23/03/2023
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Body Posture During a Skin Cancer Check on Recall of Sun Protection Information, Motivation to Adhere and Adherence to recommendations.
Scientific title
The Effect of Body Posture During a Skin Check Consultation on Recall of Sun Protection Information, Motivation to Adhere and Adherence to recommendations in UV Skin Damage Patients.
Secondary ID [1] 309187 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
UV skin damage 329321 0
Actinic keratosis 329322 0
Skin cancer 329323 0
Cognitive function 329327 0
Condition category
Condition code
Cancer 326266 326266 0 0
Non melanoma skin cancer
Cancer 326267 326267 0 0
Malignant melanoma
Skin 326268 326268 0 0
Dermatological conditions
Mental Health 326271 326271 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted at a single center, The University of Auckland Clinical Research Centre at the Grafton campus. It will involve a one-off in-person session which will take approximately 40 minutes and will be conducted one-on-one by a consultant dermatologist.

Participants will be randomized to either an upright condition (intervention) or a reclined condition (active control). The upright posture will be manipulated discreetly by the consultant dermatologist who will ask participants to sit in a chair (upright condition) in the exam room. The chair will have an upright back to encourage an upright seated posture. The dermatologist will also inform the participant that he would like them to sit up straight during the consultation so that he can properly assess their skin. He will ask them to correct their posture if needed. The same chair will be used for all participants in the intervention group and the dermatologist will stand in the same position to reduce differences in head angle.


Intervention code [1] 325634 0
Behaviour
Comparator / control treatment
In the reclined condition, the reclined posture will be manipulated discreetly by the consultant dermatologist who will ask the participant to lie in the bed for the skin check. The bed will be reclined at a 45-degree angle and a pillow will be placed behind the patient’s back. This is designed to simulate what could happen in a clinical context if a patient is being spoken to will in a hospital bed. The participant will lay in the bed in this reclined position for the skin check and while being given health information.

Control group
Active

Outcomes
Primary outcome [1] 334144 0
Recall of sun protection information is the primary outcome. Participants will be asked to free recall everything they can remember form the consultation about how to practice good sun protection behavior. This will be measured using a coding system designed from the health information scripts. This coding system has been used in past research and derived from Sanderberg et al. (2012).
Timepoint [1] 334144 0
Immediately after the consultation and at four weeks post consultation.
Secondary outcome [1] 419465 0
Self-reported sun protection behaviour. The items questionnaire were developed by the researchers based on the New Zealand sun protection guidelines (Cancer Society New Zealand, 2022). This measure is like the measure used by Manne et al. (2021) but assesses sun protection behaviour over the past week rather than asking generally what participants do on a sunny day.
Timepoint [1] 419465 0
Baseline and at four weeks post consultation.
Secondary outcome [2] 419466 0
Motivation to engage in sun protection behaviours will be assessed using self-report items developed by the researchers based on New Zealand sun safe guidelines (Cancer Society New Zealand, 2022).
Timepoint [2] 419466 0
Immediately after consultation
Secondary outcome [3] 419467 0
Alertness will be measured using a single linear non-numeric visual analogue scale asking subjects to rate how alert they feel from not alert to alert. This item comes from the Bond-Lader VAS (Mood Rating Scale) and is a commonly used method for measuring alertness (Bond & Lader, 1974).
Timepoint [3] 419467 0
Baseline and immediately after the consultation
Secondary outcome [4] 419468 0
Blood pressure will be measured as an indicator of autonomic nervous system activity and cardiovascular function. Blood pressure will be measured using a blood pressure cuff at two time points.
Timepoint [4] 419468 0
Baseline and immediately after the consultation.
Secondary outcome [5] 419469 0
Perceived risk of skin cancer will be measured using two items on a five-point Likert scale (very unlikely to very likely). This measure is adapted from Schüz and Eid (2013) to fit the adult sample for the current study as their study was conducted in adolescents.
Timepoint [5] 419469 0
Baseline and immediately after the consultation.
Secondary outcome [6] 419470 0
State anxiety. To measure this, a short form of the State-Trait Anxiety inventory will be used (Marteau & Bekker, 1992).
Timepoint [6] 419470 0
Baseline and immediately after the consultation
Secondary outcome [7] 419772 0
Sleepiness will be measured using a single linear non-numeric visual analogue scale asking subjects to rate how sleepy they feel from not sleepy to sleepy. This item comes from the Bond-Lader VAS (Mood Rating Scale) and is a commonly used method for measuring alertness (Bond & Lader, 1974).
Timepoint [7] 419772 0
Baseline and immediately after the consultation
Secondary outcome [8] 419774 0
Heart rate will be measured as an indicator of autonomic nervous system activity and cardiovascular function. Heart rate will be measured using a blood pressure cuff at two time points.
Timepoint [8] 419774 0
Baseline and Immediately after the consultation

Eligibility
Key inclusion criteria
(1) Participants are able to understand, read and write/type in English
(2) Participants are aged 18 to 55 years
(3) Have some level of UV related skin damage.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have impaired vision or hearing that makes it difficult to independently use the computer to fill out questionnaires or hear the dermatologist and resercher.

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using an online randomization tool
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using G*Power 3.1 software (Faul et al., 2009). A power of .80 and alpha level of .05 were used as according to convention for psychology research (Cohen, 1992). A large effect size was found by Michalak et al. (2014) of partial eta squared=.12 in their study of the effect of posture on the recall of emotional memories. Price et al. (2012) found a moderate effect size of partial eta-squared = .25 for the effect of posture on startle eye blink responses which are associated with approach motivation. Based on the literature a medium effect size of f=.25 for a repeated measures ANOVA was selected for the calculation giving a total sample size of N=98. A sample size of 108 (10% more) will be used for the study to account for the possibility of missing data and loss to follow up.

IBM SPSS software will be used to analyze the data. The data will be assessed for normality using Shapiro-Wilk tests and Levene’s Test will be used to assess homogeneity of variance. Data will also be inspected for missing data and outliers which will be dealt with on a case-by-case basis. If the data is not normal steps will be taken to transform it appropriately, using bootstrapping, or non-parametric tests.
Descriptive statistics will be used to assess the characteristics of the sample. To investigate differences between the groups for demographic and baseline variables, chi-square and independent t-tests will be used.
To assess the primary outcome of differences in the recall of health information between groups at the two time points a repeated measures mixed ANOVA will be used. ANCOVA analyses will be conducted to assess difference between groups in changes to physiological and self-report measures from baseline to after the consultation, controlling for baseline values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/03/2023
Actual
24/03/2023
Date of last participant enrolment
Anticipated
18/08/2023
Actual
26/09/2023
Date of last data collection
Anticipated
15/09/2023
Actual
24/10/2023
Sample size
Target
108
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 25319 0
New Zealand
State/province [1] 25319 0
Auckland

Funding & Sponsors
Funding source category [1] 313384 0
University
Name [1] 313384 0
The University of Auckland
Country [1] 313384 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] 315148 0
None
Name [1] 315148 0
Address [1] 315148 0
Country [1] 315148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312600 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 312600 0
Auckland Health Research Ethics Committee
The University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 312600 0
New Zealand
Date submitted for ethics approval [1] 312600 0
23/01/2023
Approval date [1] 312600 0
13/03/2023
Ethics approval number [1] 312600 0
AH25557

Summary
Brief summary
Body posture has been linked to cognitive processes including memory. Upright postures have been associated with improved memory, greater approach motivation, greater alertness, and more positive mood compared to slumped or reclined postures. Patients are often reclined in a hospital bed when given information which may be impacting memory formation and recall.

The current study aims to test whether an upright seated posture can increase recall of diagnosis, treatment and sun protection information compared to a reclined posture in a dermatology patient population. This study will also investigate motivation to do recommended behaviours adherence as well as look at possible mechanisms for the effect of posture on memory by looking at blood pressure, heart rate and self- reported alertness.

It is hypothesized that an upright body posture will be associated with greater recall of diagnosis relevant information and sun protection information immediately after consultation and at four weeks follow up compared to a reclined posture.

It is also hypothesized that that an upright posture will be associated with greater motivation to follow advice about sun protection behaviours and a greater number of sun protection behaviours reported in the four weeks post consultation.

It is hypothesized that upright posture will be associated with greater self-reported alertness, higher heart rate, higher blood pressure during the consultation, and associated with greater increases in perceived risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125246 0
Prof Elizabeth Broadbent
Address 125246 0
Department of Psychological Medicine,
School of Medicine,
Building 507, 22-30 Park Avenue
Grafton, Auckland,
New Zealand 1023
Country 125246 0
New Zealand
Phone 125246 0
+6499236756
Fax 125246 0
Email 125246 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 125247 0
Prof Elizabeth Broadbent
Address 125247 0
Department of Psychological Medicine,
School of Medicine,
Building 507, 22-30 Park Avenue
Grafton, Auckland,
New Zealand 1023
Country 125247 0
New Zealand
Phone 125247 0
+6499236756
Fax 125247 0
Email 125247 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 125248 0
Prof Elizabeth Broadbent
Address 125248 0
Department of Psychological Medicine,
School of Medicine,
Building 507, 22-30 Park Avenue
Grafton, Auckland,
New Zealand 1023
Country 125248 0
New Zealand
Phone 125248 0
+6499236756
Fax 125248 0
Email 125248 0
e.broadbent@auckland.ac.nz

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?

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.