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Trial registered on ANZCTR


Registration number
ACTRN12623000585628
Ethics application status
Approved
Date submitted
15/05/2023
Date registered
29/05/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
29/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of cryotherapy on the discomfort of sterile water injections
Scientific title
Does the use of cryotherapy reduce the injection discomfort associated with sterile water injections used to manage back pain in women during labour and birth
Secondary ID [1] 309192 0
None
Universal Trial Number (UTN)
Trial acronym
CryoS trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour pain 329335 0
Condition category
Condition code
Reproductive Health and Childbirth 326277 326277 0 0
Childbirth and postnatal care
Anaesthesiology 327001 327001 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in labour and receiving four intradermal injections of 0.1 - 0.3 millilitres of sterile water for management of back pain in labour assessed by visual analogue scale equal to or greater than 6 will receive either the application of a vapocoolant spray applied to the injections sites. The vapocoolant spray PainEase® is manufactured by Gebauer. PainEase® spray and contains 1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane which are non-flammable and. unlike ethyl chloride. are not absorbed through the skin and therefore safe to use in pregnancy. The cooling effect occurs through the rapid evaporation. The injection points will be sprayed with PainEase® spray at a distance of 8 cms from skin for a period of five to eight seconds immediately prior to administering the injections. The intervention will be delivered by two midwives working concurrently. Participants in the second intervention group will receive the application of a chemical cold pack to the injection area for 10 minutes prior to the administration of the water injections. Compliance with the administering protocol for both interventions will be recorded on the case report form.
Intervention code [1] 325637 0
Treatment: Devices
Comparator / control treatment
Women in labour and receiving four intradermal injections of 0.1 - 0.3 millilitres of sterile water for management of back pain in labour assessed by visual analogue scale equal to or greater than 6 will not receive any cryotherapy intervention prior to the administration of the water injections (standard care)
Control group
Active

Outcomes
Primary outcome [1] 334149 0
The mean difference in Visual Analogue Scale (VAS) scores of injection pain of water injections compared to control
Timepoint [1] 334149 0
At time of injections
Secondary outcome [1] 419480 0
The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control
Timepoint [1] 419480 0
at 30 minutes post injection
Secondary outcome [2] 419481 0
The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control
Timepoint [2] 419481 0
At 60 minutes post injection
Secondary outcome [3] 419482 0
The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control
Timepoint [3] 419482 0
At 90 minutes post injection
Secondary outcome [4] 419483 0
The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control
Timepoint [4] 419483 0
At 120 minutes post injection
Secondary outcome [5] 419485 0
Number of women reporting an at least 30% reduction in self reported VAS scores of back pain
Timepoint [5] 419485 0
At 30 minutes post injection
Secondary outcome [6] 419486 0
Number of women reporting an at least 30% reduction in self reported VAS scores of back pain
Timepoint [6] 419486 0
At 60 minutes post injection
Secondary outcome [7] 419487 0
Number of women reporting an at least 30% reduction in self reported VAS scores of back pain
Timepoint [7] 419487 0
At 90 minutes post injection
Secondary outcome [8] 419488 0
Number of women reporting an at least 30% reduction in self reported VAS scores of back pain
Timepoint [8] 419488 0
At 120 minutes post injection
Secondary outcome [9] 419489 0
Number of women reporting an at least 50% reduction in self reported VAS scores of back pain
Timepoint [9] 419489 0
At 30 minutes post injection
Secondary outcome [10] 419490 0
Number of women reporting an at least 50% reduction in self reported VAS scores of back pain
Timepoint [10] 419490 0
At 60 minutes post injection
Secondary outcome [11] 419491 0
Number of women reporting an at least 50% reduction in self reported VAS scores of back pain
Timepoint [11] 419491 0
At 90 minutes post injection
Secondary outcome [12] 419492 0
Number of women reporting an at least 50% reduction in self reported VAS scores of back pain
Timepoint [12] 419492 0
At 120 minutes post injection
Secondary outcome [13] 419493 0
Mean difference in skin temperature between intervention and control groups measured by infrared surface thermometer
Timepoint [13] 419493 0
prior to application of either vapocoolant or cold pack
Secondary outcome [14] 419494 0
Mean difference in skin temperature between intervention and control groups measured by infrared surface thermometer
Timepoint [14] 419494 0
Immediately following injections
Secondary outcome [15] 419495 0
Other pharmacological use prior to and after randomisation (opiods, nitrous oxide inhalation, epidurals) assessed through data linkage to perinatal records
Timepoint [15] 419495 0
At birth of infant
Secondary outcome [16] 419496 0
Non-pharmacological analgesia use prior to and after randomisation (water immersion, shower, mobility, massage, birthball, hypnobirthing) assessed through data linkage to perinatal records
Timepoint [16] 419496 0
At time of birth
Secondary outcome [17] 419497 0
Duration of active first stage labour from 4cm to 10cm cervical dilation assessed through data linkage to perinatal records
Timepoint [17] 419497 0
At time of birth
Secondary outcome [18] 419498 0
Duration of second stage labour from 10cm to birth of infant assessed through data linkage to perinatal records
Timepoint [18] 419498 0
At birth of infant
Secondary outcome [19] 419499 0
Duration of labour from birth of infant to birth of placenta assessed through data linkage to perinatal records
Timepoint [19] 419499 0
At birth
Secondary outcome [20] 419500 0
Proportion of women experiencing an unassisted vaginal birth assessed through data linkage to perinatal records
Timepoint [20] 419500 0
At birth
Secondary outcome [21] 419501 0
Proportion of women experiencing an assisted vaginal birth assessed through data linkage to perinatal records
Timepoint [21] 419501 0
At birth
Secondary outcome [22] 419502 0
Proportion of women experiencing caesarean section birth assessed through data linkage to perinatal records
Timepoint [22] 419502 0
At birth
Secondary outcome [23] 419503 0
Proportion of women experiencing an augmentation of labour assessed through data linkage to perinatal records
Timepoint [23] 419503 0
At birth
Secondary outcome [24] 419504 0
Estimated blood loss at birth in milliltres assessed through data linkage to perinatal records
Timepoint [24] 419504 0
At birth
Secondary outcome [25] 419505 0
Neonatal Apgar score
Timepoint [25] 419505 0
One minute post birth
Secondary outcome [26] 419506 0
Neonatal Apgar score
Timepoint [26] 419506 0
Five minutes post birth
Secondary outcome [27] 419507 0
Proportion of infants experiencing resuscitation (Intermittent positive pressure ventilation, CPR, medications) assessed through data linkage to perinatal records
Timepoint [27] 419507 0
At birth
Secondary outcome [28] 419508 0
Proportion of infants experiencing any Intensive Care Nursery (ICN) or Special Care Nursery (SCN) admission assessed through data linkage to perinatal records
Timepoint [28] 419508 0
At infant discharge
Secondary outcome [29] 419509 0
Length of stay in hospital (hours) assessed through data linkage to perinatal records
Timepoint [29] 419509 0
At discharge from hospital
Secondary outcome [30] 419510 0
Proportion of women fully breastfeeding at discharge assessed through data linkage to perinatal records
Timepoint [30] 419510 0
At discharge from hospital
Secondary outcome [31] 419511 0
Maternal satisfaction as measured by a postnatal survey designed specifically for the study
Timepoint [31] 419511 0
In the first two weeks following birth

Eligibility
Key inclusion criteria
In labour (spontaneous or induced)
Are equal to or greater than 16 years of age
Have a term singleton pregnancy (between 37 and 42 weeks gestation)
Have a fetus in a cephalic (head down) presentation
Experience back pain assessed by visual analogue scale VAS as equal to or greater than 6
Are able to provide informed consent
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple pregnancy
Malpresentation (breech, transverse, shoulder)
Have a serious medical condition at onset of labour (e.g. severe hypertension, diabetes requiring insulin infusion
Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

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)
Blinding of allocation to the study intervention will be undertaken using opaque sealed envelopes prepared by persons not associated with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared using a computer-generated list of random numbers in blocks of two to four
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Both the intention-to-treat and per protocol populations will be analysed. Only participants whose recruitment found to be a major breach of protocol will be excluded. Randomisation and stratification should ensure that groups are equal in baseline characteristics. Descriptive statistics will be reported as frequency and percent, mean and standard deviation or median and interquartile range. The primary outcome is VAS score at time of injection. The comparisons of interest are between control and vapocoolant, control and ice pack and vapocoolant and ice pack. The primary outcome will be analysed using a one-way ANOVA and the mean difference and 95% confidence intervals reported for each comparison. All of the VAS scores over time will be modelled using a linear mixed effects with three-levels: measurement of VAS (level 1) nested in individual participants (level 2) within hospitals (level 3). To explore insensitivity of the pain changes to data missing at random, analyses were repeated using multiple imputation. For secondary outcome measures collected at a single time point, categorical data will be analysed using the Pearson chi-squared test or Fisher’s Exact test and continuous data will be analysed with ANOVA or if not normally distributed the Kruskal-Wallis test. Multiple regression maybe explored if there are differences in baseline measures. To account for multiple comparisons a Bonferroni correction will be applied. Given there will be three pairwise comparison a p-value of 0.017 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24280 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 24281 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [3] 24282 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 39822 0
4029 - Herston
Recruitment postcode(s) [2] 39823 0
4101 - South Brisbane
Recruitment postcode(s) [3] 39824 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 313386 0
Government body
Name [1] 313386 0
NHMRC
Country [1] 313386 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Queensland 4072
Country
Australia
Secondary sponsor category [1] 315151 0
None
Name [1] 315151 0
Address [1] 315151 0
Country [1] 315151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312603 0
Metro North Human Research Ethics Committee
Ethics committee address [1] 312603 0
Level 14 Block 7
Royal Brisbane and Women's Hospital
Herston
Queensland
4029
Ethics committee country [1] 312603 0
Australia
Date submitted for ethics approval [1] 312603 0
20/04/2023
Approval date [1] 312603 0
22/06/2023
Ethics approval number [1] 312603 0
HREC/2023/MNHA/95180

Summary
Brief summary
The aim of this trial is to compare the effectiveness of a vapocoolant (rapidly cooling) spray to a chemical ice pack to usual care for reducing the injection pain experienced by labouring women when water injections are used to manage back pain in labour. Participants will be women in labour at term with a single, head down fetus and requesting analgesia for back pain in labour. Labour back pain occurs in approximately one third of all labours and sterile water injections, which is standard care at all participating sites, has been shown in placebo controlled trials conducted by members of our team, to provide significant pain relief. However, the administration pain experienced by women receiving water injections is significant and in known to act as a deterrent to use. We will randomise eligible women who have elected to have water injections for labour back
pain and consent to participate to receive either vapocoolant spray, application of cold packs for 10 minutes prior to injections, or a control group of usual care in which neither the vapocoolant spray or cold packs are used. We expect the study to provide data on the best approach to mitigating the pain of water injections
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125254 0
Dr Nigel Lee
Address 125254 0
Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072
Country 125254 0
Australia
Phone 125254 0
+61 0427231390
Fax 125254 0
Email 125254 0
nigel.lee@uq.edu.au
Contact person for public queries
Name 125255 0
Dr Nigel Lee
Address 125255 0
Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072
Country 125255 0
Australia
Phone 125255 0
+61 0427231390
Fax 125255 0
Email 125255 0
nigel.lee@uq.edu.au
Contact person for scientific queries
Name 125256 0
Dr Nigel Lee
Address 125256 0
Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072
Country 125256 0
Australia
Phone 125256 0
+61 0427231390
Fax 125256 0
Email 125256 0
nigel.lee@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De identified participant data underlying published results only, trial protocol
When will data be available (start and end dates)?
12 months following main results publication, no end date
Available to whom?
Researchers who provide a methodologically sound proposal with ethical approval and upon establishment of a data sharing agreement at the discretion of the Chief Investigator
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Secure access from the University of Queensland Data repository upon approval by the Chief Investigator Dr Nigel Lee nigel.lee@uq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19233Study protocolSecure access from the University of Queensland Data repository upon approval by the Chief Investigator Dr Nigel Lee nigel.lee@uq.edu.au  nigel.lee@uq.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.