Condition category
Pregnancy and Childbirth
Date applied
11/05/2005
Date assigned
21/09/2005
Last edited
25/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Linda Kimber

ORCID ID

Contact details

Horton Maternity Hospital
Oxford Road
Banbury
Oxford
OX16 9AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project Reference Number 04/Q1606/70

Study information

Scientific title

Acronym

ALPS

Study hypothesis

Does regular use of an established massage, breathing and visualization programme, from 36 weeks until birth, reduce maternal pain perception and
pharmacological analgesia in labour, compared to the effects of standard antenatal preparation and placebo?

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Labour Pain Management

Intervention

Intervention: Massage group
The model is practised as follows: women attend a class at 35-37 weeks gestation with their chosen birth companion where the programme is introduced by the midwife/therapist. The importance of breathing awareness is emphasised and massage techniques are taught, synchronising them with breathing and visualisation. They are asked to practise this programme, with the help of a video, for at least 3 evenings a week, for about 30-45 minutes, until 39 weeks and then a combination of techniques every evening, until hospital admission for labour/induction. During labour in hospital, the intervention is supported by a self-selected group of midwives, who have successfully completed an accredited massage course and attended one information session on the needs and expectations of women in the placebo arm of the trial.

Placebo: Breathing/Visualisation
It is possible that the addition of an extra antenatal class specifically devoted to coping with pain in labour will improve outcomes for women in the Massage group regardless of the use of massage. Therefore, this "placebo" group will be included as a second comparision to test whether additional social support in the massage group accounts for any observed difference. Couples receive an additional antenatal class devoted to coping with labour, which offers breathing techniques and visualisation, without the use of massage. They are asked to practise this programme, for at least 3 evenings a week, for about 30-45 minutes, until 39 weeks and then a combination of techniques every evening until hospital admission for labour/induction. During labour in hospital, the intervention is supported by a self-selected group of midwives, who have successfully completed an accredited massage course and attended one information session on the needs and expectations of women in the placebo arm of the trial.

Control: Usual care
The women and companions in this group will be asked to attend the usual antenatal preparation classes that are currently available at the trial site. At present there are 4 two-hour classes.

Blinding to such visibly different options will not be possible. However, information offered to women will focus on the use of complementary strategies for coping with pain, rather than focusing only on the use of massage and will not emphasise, or imply superiority of, one form of care over another. Instead current lack of knowledge about what helps women to cope with labour will be emphasised. The use of a Placebo group guards against the potentially confounding factor of additional information, social support and other non-pharmacological strategies for pain management.
A self-selected group of trained midwives will care for women in all three arms of the trial. This has been done to ensure that:
1. All participants are cared for by professionals who have achieved the same level of knowledge and competence
2. Midwives are adequately trained to undertake the intervention in a safe and effective manner, as and when necessary during labour
3. Midwives are adequately informed to support couples in the placebo group

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure will be self-reported labour pain. The visual analogue scale (VAS), a simple, widely used measure validated for use to assess overall labour pain, within 48 hours of birth will be given to all participating women to complete before transfer from labour care. The scale will be given to women during the second hour following birth when hormonal interactions that begin immediately following birth initiate maternal-infant contact and pain from perineal trauma is usually absent. This is ethically and physiologically preferable to use during labour, or to use of the more complex and time-consuming Magill Pain Questionnaire, that is also validated for such research.

Secondary outcome measures

Other methods of pain relief, obstetric interventions, birth outcomes, cord blood levels of stress hormones and women's satisfaction and sense of control.

Overall trial start date

01/12/2004

Overall trial end date

30/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible women will include all pregnant women booked for care in the study period except for listed exclusions.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

90

Participant exclusion criteria

1. Multiple pregnancy
2. Planned caesarean section
3. Medical problems that would preclude the use of massage techniques
4. Women who have previously used the massage programme
5. Women who have a strong preference for a particular form of pain relief
6. Women who do not speak fluent English
7. Women not intending to have a birth companion

Recruitment start date

01/12/2004

Recruitment end date

30/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Horton Maternity Hospital
Oxford
OX16 9AL
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Research & Development Department
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DZ
United Kingdom

Sponsor type

Research council

Website

http://www.oxfordradcliffe.nhs.uk/

Funders

Funder type

Research council

Funder name

Oxfordshire Health Services Research Committee (UK) (Application for Research Grant Reference - CM001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18304848

Publication citations

  1. Results

    Kimber L, McNabb M, Mc Court C, Haines A, Brocklehurst P, Massage or music for pain relief in labour: a pilot randomised placebo controlled trial., Eur J Pain, 2008, 12, 8, 961-969, doi: 10.1016/j.ejpain.2008.01.004.

Additional files

Editorial Notes