|
Welcome
|
|
21 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Self-Hypnosis for Intrapartum Pain management (SHIP) trial |
| ISRCTN | ISRCTN27575146 |
| ClinicalTrials.gov identifier | |
| Public title | Self-Hypnosis for Intrapartum Pain management (SHIP) trial |
| Scientific title | Self-Hypnosis for Intrapartum Pain management (SHIP): a single organisation, two-site pragmatic exploratory non-blinded randomised controlled trial with blinded analysis based on intention to treat, and contextualised by interviews, focus groups, logs, and questionnaires |
| Acronym | SHIP Trial |
| Serial number at source | PB-PG-0808-16234 |
| Study hypothesis | There will be no difference in rates of epidural usage in labour for maternal request between women randomised to an antenatal group self-hypnosis programme and those randomised to usual care. |
| Lay summary | |
| Ethics approval |
1. NHS IRAS Ethics Committee System approved
2. University of Central Lancashire Faculty of Health Ethics Committee approved |
| Study design | Multicentre pragmatic exploratory non-blinded randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Intrapartum maternity care |
| Participants - inclusion criteria |
All nulliparous women who:
1. Have a singleton, viable, cephalic pregnancy 2. Are planning a vaginal birth in hospital 3. Have no current history of being under treatment for psychiatric disorders or of hypertensive disorders 4. Speak and read English 5. Consent to take part 6. Who are available to attend the intervention sessions 7. Aged between 18 and 45 years |
| Participants - exclusion criteria | Does not meet the inclusion criteria |
| Anticipated start date | 01/08/2010 |
| Anticipated end date | 31/07/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 800 |
| Interventions |
Intervention group:
1. Each group hypnosis programme will be provided by one of 4 midwives with appropriate training 2. They will not be present during the labour and birth of study participants 3. The programmes will be provided in addition to usual care 4. Each programme will be delivered on one of the two Trust sites, with evening or weekend options, to groups of 5 - 10 women and their planned birth companions (a total maximum of 20 people) in 2 sessions separated by 3 weeks (32 weeks gestation, 35 weeks gestation 5. Each session will last 90 minutes 6. Four sets of hypnosis programmes will be run every 4 weeks with evening and weekend options 7. The hypnosis scripts will be adapted from those tested in the current Australian Hatch Trial 8. The sessions will include self-hypnosis induction techniques, exercises relating to confidence, coping and strength in labour, suggestions for time distortion, a labour rehearsal involving recurrent fractionation and staircase imagery, and pain control and dissociation techniques. Participants will also be asked to listen to a CD of reinforcement exercises at least once a day until their baby is born Control group: 'Usual care' will consist of attendance at any antenatal classes usually offered to nulliparous women, and standard clinical care Women in both groups will be free to request any additional pain relief they require during labour, and this will be emphasised in the information leaflets. |
| Primary outcome measure(s) | Rates of epidural usage in labour for maternal request |
| Secondary outcome measure(s) |
1. Mode of birth and other maternal labour outcomes
2. Neonatal wellbeing 3. Participants preferences relating to hypnosis 4. Anxiety and fear about labour 5. Recall of labour pain 6. Ability to manage labour 7. Satisfaction with self during labour 8. Clinical and psychological morbidity and well-being 9. Economic cost-benefit analysis 10. Experiences of women, their birth companions, and their caregivers 11. Follow up will continue to 6 weeks postnatal |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-16234) |
| Trial website | |
| Publications | |
| Contact name | Prof Soo Downe |
| Address |
Room 116
Brook Building ReaCH Group School of Health University of Central Lancashire |
| City/town | Preston |
| Zip/Postcode | PR1 2HE |
| Country | United Kingdom |
| Tel | +44 (0)1772 893815 |
| sdowne@uclan.ac.uk | |
| Sponsor | East Lancashire Hospitals NHS Trust (UK) |
| Address |
Research and Development Office
Level 3, Royal Blackburn Hospital Haslingden Road |
| City/town | Blackburn |
| Zip/Postcode | BB2 3HH |
| Country | United Kingdom |
| Linda.Gregson@elht.nhs.uk | |
| Sponsor website: | http://www.elht.nhs.uk/ |
| Date applied | 29/01/2011 |
| Last edited | 25/03/2011 |
| Date ISRCTN assigned | 25/03/2011 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|