We are performing an observational prospective study of women undergoing planned caesarean section. Women are recruited from antenatal clinics at the John Radcliffe Hospital, part of the Oxford University Hospital (OUH) Trust, Oxford. All women, aged 18-45, with the ability to provide informed consent and meeting the study inclusion criteria are invited to join the study.
Patients are excluded who:
- have pre-pregnancy painful conditions;
- have epilepsy or other neurological conditions;
- have had surgery during pregnancy;
- are from vulnerable groups;
- have a poor understanding of English;
- have no access to a telephone
Patient screening, recruitment and consent
Women who meet the eligibility criteria and are seen at the time of their routine antenatal appointment are invited to take part in the study by their obstetric consultant/midwife or a member of the research team. Women are given a participant information pack to take home with a reply slip to return if interested in taking part in the study. If the woman expresses an interest in the study and gives permission, we will contact her by telephone 24 hours or more after she has been given the information pack. This follow-up phone call checks that she has had a chance to read the information sheets and we can answer questions if she is still interested, or exclude her from further contact if she does not wish to take part in the study. This enables us to arrange for the research team to attend the pre-assessment clinic appointment (PAC) and obtain consent for study inclusion. Once consented, a medical screening form is completed and the patient is given a pre-operative questionnaire to fill in at home and return on the day of surgery.
A comprehensive list of the data collected is as follows:
Quality of life
Psychology and illness attitudes
Centre for Epidemiological Studies – Depression (CES-D)2
State-Trait Anxiety Index (STAI)3
State anxiety - how you feel right now
Trait anxiety - how you feel generally
Locus of Control (IPC)5
Reward and punishment (BIS-BAS)6
Illness attitudes and behaviours (IAS)7
Brief Pain Inventory –short form (BPI-SF)8
McGill - short form (MPQ-SF)9
Pain catastrophizing scale (PCS)10
Neuropathic pain questionnaire (painDETECT PD-Q)11
Expectations of pain after surgery
Previous pain experience
Pittsburgh Sleep Quality Index (PSQI)12
Munich Chronotype Questionnaire (MTCQ)13
Further questions include:
Previous obstetric history
Physical/verbal abuse history
Attitudes towards CS
Day of surgery
Patients are given a questionnaire to ask about their sleep quality and quantity the night before the operation. Blood is taken pre-operatively for hormone levels (cortisol, oestradiol, progesterone, testosterone) and analysis for genetic polymorphisms.
The medical practitioners complete forms detailing the surgical and anaesthetic techniques at the time of surgery. Patients are also asked how much pain and discomfort they have experienced during the operation.
Acute post-operative pain
Information on pain and analgesia requirements is acquired post-operatively in person on the ward at 6 hours and day 2, and then by telephone on days 7 and 30. Women are asked questions about their pain from standardized questionnaires that include pain scores and location, analgesic consumption as well as sleep quality and disturbance.
Long–term follow up
Women are sent postal questionnaires at 4 and 12 months post-operatively. They are completed at home, and returned in a pre-paid envelope. The long-term follow up features a sub-set of the questions from the pre-operative questionnaire. Additionally patients are asked about sensory dysfunction, acceptance of their chronic pain14 (where relevant), acute post-operative pain recall, sexual dysfunction and any other painful experiences since the operation. Patients are asked about their attitudes to being a mother15.
Data collection and analysis
The primary study outcome is to assess the incidence of pain at one year post-operatively and its impact on quality of life. Secondary objectives are to identify the predictive factors leading to the development of persistent post-operative pain after CS. These factors will be evaluated using a multivariate pattern analysis approach.
- Kaegi, L. Medical Outcomes Trust Conference presents dramatic advances in patient-based outcomes assessment and potential applications in accreditation. Jt Comm J Qual Improv 1999. 25(4): 207-18.
- Radloff, L.S., The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1977. 1: p. 385-401.
- Spielberger CD., et al. Manual for the State-Trait Anxiety Inventory. 1983, Palo Alto (CA): Consulting Psychologists Press.
- Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol 1994. 67(6): 1063-78.
- Loas, G., et al., Operationalization of the "locus of control" concept: translation and first validation study of the Levenson control scale (IPC: the internal powerful others and chance scale). Annales medico-psychologiques, 1994. 152(7): p. 466-9.
- Carver, C.S. and T.L. White, Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: The BIS/BAS scales. Journal of Personality and Social Psychology, 1994. 67: p. 319-333.
- Dammen, T., S. Friis, and O. Ekeberg, The Illness Attitude Scales in chest pain patients: a study of psychometric properties. Journal of psychosomatic research, 1999. 46(4): p. 335-42.
- Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 1983. 17: 197-210.
- Melzack R. The McGill pain questionnaire: from description to measurement. Anesthesiology 2005. 103: 199-202.
- Osman A et al. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med 1997. 20: 589-605.
- Freynhagen R et al. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin 2006. 22: 1911-20.
- Buysse, D.J., et al., The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research, 1989. 28(2): p. 193-213.
- Roenneberg, T., et al., Epidemiology of the human circadian clock. Sleep medicine reviews, 2007. 11(6): p. 429-38.
- McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain, 2004. 107: 159-66.
- Matthey, S., Assessing the experience of motherhood: the Being a Mother Scale (BaM-13). Journal of affective disorders, 2011. 128(1-2): p. 142-52.