Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
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Purpose
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.
| Condition |
|---|
|
Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain |
- Pain in relation to breastfeeding [ Time Frame: 6 weeks post-delivery ] [ Designated as safety issue: No ]
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.
- To determine the effects of suggestion and mood on pain [ Time Frame: 6wks ] [ Designated as safety issue: No ]
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 determine the effects of suggestion (placebo vs. nocebo) on the pain experience.
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.
- To understand patients' preference for duration versus intensity of pain [ Time Frame: 48 h ] [ Designated as safety issue: No ]We will also determine pain preferences as relating to pain intensity and duration by another questionnaire we have developed.
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Nocebo
Told breastfeeding may worsen pain
|
|
No treatment
Told nothing
|
|
Placebo
Told will improve pain
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
30 patients posy cesarean delivery. 100 patients post vaginal delivery.
Inclusion Criteria:
- Age 18 - 40 yrs
- ASA 1 or 2
- Singleton gestation
- Greater or equal to 37 weeks gestation
- Vaginal delivery
- Scheduled cesarean delivery with a Pfannenstiel incision
Exclusion Criteria:
- Chronic pain
- Patients prescribed regular analgesia medication ante-natally
- Substance abuse
- Classical cesarean incision
- Emergency cesarean delivery
- Patients not planning to breastfeed
- Psychiatric or cognitive disorder, including anxiety or depression
- Physicians, labor and delivery nurses, midwives
Contacts and Locations| Contact: Brendan Carvalho | (650) 861-8607 | bcarvalho@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Brendan Carvalho 650-861-8607 bcarvalho@stanford.edu | |
| Contact: Gillian Hilton ghilton@stanford.edu | |
| Principal Investigator: Brendan Carvalho | |
| Principal Investigator: | Brendan Carvalho | Stanford University |
More Information
No publications provided
| Responsible Party: | Brendan Carvalho, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01417260 History of Changes |
| Other Study ID Numbers: | SU-08092011-8247, IRB 22053 |
| Study First Received: | August 11, 2011 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013