Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
Condition: Pain
Study type: Observational

Summary: 
      Oxytocin is a hormone that is released in response to distension of the cervix and uterus
      during labor, and after breast feeding as a result of nipple stimulation. In addition to
      oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal
      behavior including bonding, social recognition, anxiolysis, sexual arousal.

      The role of oxytocin in pain modulation has recently been highlighted. Intranasal or
      intrathecal (spinal) administration has been found to impact pain modulation. The
      administration of intravenous oxytocin has not provided effective analgesia because oxytocin
      is unable to pass to your brain. The role of breastfeeding on analgesia is poorly
      investigated, which is why we are carrying out this study.
    

Detailed description: 
      Patients will be recruited by a member of the research team when the patient is admitted to
      labor or delivery and when they are in the post-natal floor.

      Patients will be divided into two groups initially depending on mode of delivery, vaginal vs.
      cesarean. The vaginal delivery group will be randomized into three groups. One group will be
      told that we are investigating the effect of oxytocin on pain intensity, the second group
      will be told that it reduces pain intensity, the third group will be told that it increases
      pain intensity.

      The cesarean group are not going to be randomized, they will be told we are investigating the
      effect of oxytocin on pain intensity.

      Demographic and obstetric will be collected by patient questioning as well as from the
      medical record on Day 1 post delivery. Analgesia data from the medical record will also be
      collected on days 1 and 2 post-delivery.

      The primary outcome measure will be change in pain scores (0=no pain, 10=worse pain
      imaginable) during and after breastfeeding compared to pain before. We will examine both
      vaginal, cramping and surgical pain as appropriate.

      The patients will be given a breastfeeding diary to complete, which will record the average
      pain scores (0-10) before, during and after each breastfeed.

      Secondary outcome measure will include: Depression, PTDS, and other outcome measures.
      Patients will also be asked to complete pain intensity and depression (The Edinburgh
      Depression Scale) and a PTSD questionnaires. We will also determine pain preferences as
      relating to pain intensity and duration by another questionnaire.

      At 6 weeks post-delivery, a member of the research team will call the participant to ask
      questions regarding current pain scores, success of breastfeeding and weight of the baby.

      The study end-point is 6 weeks post-delivery. We will debrief participants who had deception
      at completion of the whole study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients posy cesarean delivery. 100 patients post vaginal delivery.