Alternative Labour Pain Strategies Study
| ISRCTN | ISRCTN43151584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43151584 |
| Secondary identifying numbers | Project Reference Number 04/Q1606/70 |
- Submission date
- 11/05/2005
- Registration date
- 21/09/2005
- Last edited
- 25/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Linda Kimber
Scientific
Scientific
Horton Maternity Hospital
Oxford Road
Banbury
Oxford
OX16 9AL
United Kingdom
Study information
| Study design | Randomised placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ALPS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2004 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 90 |
| Key inclusion criteria | Eligible women will include all pregnant women booked for care in the study period except for listed exclusions. |
| Key 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 |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Horton Maternity Hospital
Oxford
OX16 9AL
United Kingdom
OX16 9AL
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Research council
Research council
Research & Development Department
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DZ
United Kingdom
| Website | http://www.oxfordradcliffe.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Research council
Oxfordshire Health Services Research Committee (UK) (Application for Research Grant Reference - CM001)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No |
