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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]

None

Universal Trial Number (UTN)

Trial acronym

CryoS trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Labour pain

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Anaesthesiology

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]

Treatment: Devices

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

The mean difference in Visual Analogue Scale (VAS) scores of injection pain of water injections compared to control

Timepoint [1]

At time of injections

Secondary outcome [1]

The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control

Timepoint [1]

at 30 minutes post injection

Secondary outcome [2]

The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control

Timepoint [2]

At 60 minutes post injection

Secondary outcome [3]

The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control

Timepoint [3]

At 90 minutes post injection

Secondary outcome [4]

The mean difference in Visual Analogue Scale (VAS) scores of back pain following water injections compared to control

Timepoint [4]

At 120 minutes post injection

Secondary outcome [5]

Number of women reporting an at least 30% reduction in self reported VAS scores of back pain

Timepoint [5]

At 30 minutes post injection

Secondary outcome [6]

Number of women reporting an at least 30% reduction in self reported VAS scores of back pain

Timepoint [6]

At 60 minutes post injection

Secondary outcome [7]

Number of women reporting an at least 30% reduction in self reported VAS scores of back pain

Timepoint [7]

At 90 minutes post injection

Secondary outcome [8]

Number of women reporting an at least 30% reduction in self reported VAS scores of back pain

Timepoint [8]

At 120 minutes post injection

Secondary outcome [9]

Number of women reporting an at least 50% reduction in self reported VAS scores of back pain

Timepoint [9]

At 30 minutes post injection

Secondary outcome [10]

Number of women reporting an at least 50% reduction in self reported VAS scores of back pain

Timepoint [10]

At 60 minutes post injection

Secondary outcome [11]

Number of women reporting an at least 50% reduction in self reported VAS scores of back pain

Timepoint [11]

At 90 minutes post injection

Secondary outcome [12]

Number of women reporting an at least 50% reduction in self reported VAS scores of back pain

Timepoint [12]

At 120 minutes post injection

Secondary outcome [13]

Mean difference in skin temperature between intervention and control groups measured by infrared surface thermometer

Timepoint [13]

prior to application of either vapocoolant or cold pack

Secondary outcome [14]

Mean difference in skin temperature between intervention and control groups measured by infrared surface thermometer

Timepoint [14]

Immediately following injections

Secondary outcome [15]

Other pharmacological use prior to and after randomisation (opiods, nitrous oxide inhalation, epidurals) assessed through data linkage to perinatal records

Timepoint [15]

At birth of infant

Secondary outcome [16]

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]

At time of birth

Secondary outcome [17]

Duration of active first stage labour from 4cm to 10cm cervical dilation assessed through data linkage to perinatal records

Timepoint [17]

At time of birth

Secondary outcome [18]

Duration of second stage labour from 10cm to birth of infant assessed through data linkage to perinatal records

Timepoint [18]

At birth of infant

Secondary outcome [19]

Duration of labour from birth of infant to birth of placenta assessed through data linkage to perinatal records

Timepoint [19]

At birth

Secondary outcome [20]

Proportion of women experiencing an unassisted vaginal birth assessed through data linkage to perinatal records

Timepoint [20]

At birth

Secondary outcome [21]

Proportion of women experiencing an assisted vaginal birth assessed through data linkage to perinatal records

Timepoint [21]

At birth

Secondary outcome [22]

Proportion of women experiencing caesarean section birth assessed through data linkage to perinatal records

Timepoint [22]

At birth

Secondary outcome [23]

Proportion of women experiencing an augmentation of labour assessed through data linkage to perinatal records

Timepoint [23]

At birth

Secondary outcome [24]

Estimated blood loss at birth in milliltres assessed through data linkage to perinatal records

Timepoint [24]

At birth

Secondary outcome [25]

Neonatal Apgar score

Timepoint [25]

One minute post birth

Secondary outcome [26]

Neonatal Apgar score

Timepoint [26]

Five minutes post birth

Secondary outcome [27]

Proportion of infants experiencing resuscitation (Intermittent positive pressure ventilation, CPR, medications) assessed through data linkage to perinatal records

Timepoint [27]

At birth

Secondary outcome [28]

Proportion of infants experiencing any Intensive Care Nursery (ICN) or Special Care Nursery (SCN) admission assessed through data linkage to perinatal records

Timepoint [28]

At infant discharge

Secondary outcome [29]

Length of stay in hospital (hours) assessed through data linkage to perinatal records

Timepoint [29]

At discharge from hospital

Secondary outcome [30]

Proportion of women fully breastfeeding at discharge assessed through data linkage to perinatal records

Timepoint [30]

At discharge from hospital

Secondary outcome [31]

Maternal satisfaction as measured by a postnatal survey designed specifically for the study

Timepoint [31]

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]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Mater Mother's Hospital - South Brisbane

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4029 - Herston

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment postcode(s) [3]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

St Lucia, Queensland 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Human Research Ethics Committee

Ethics committee address [1]

Level 14 Block 7 
Royal Brisbane and Women's Hospital
Herston
Queensland
4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/04/2023

Approval date [1]

22/06/2023

Ethics approval number [1]

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

Dr Nigel Lee

Address

Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

Contact person for public queries

Name

Nigel Lee

Address

Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

Contact person for scientific queries

Name

Nigel Lee

Address

Level 3 Chamberlain Building
School of Nursing, Midwifery and Social Work
University of Queensland
St Lucia,
Queensland 4072

Country

Australia

Phone

+61 0427231390

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19233	Study protocol	Secure access from the University of Queensland Data repository upon approval by the Chief Investigator Dr Nigel Lee [email protected]		[email protected]

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

Trial Review

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