Acute Pain
Conditions
Brief summary
Effective management of postoperative pain is a priority for women undergoing cesarean delivery. Despite availability of modern analgesics, postoperative pain management remains a challenge. One opportunity to enhance the analgesic effect of the pharmacological treatments given to people suffering from pain (and not just pain) is through increasing the expectations for pain relief following treatment. Although much knowledge has been accumulated about the significant effect of expectations on pain, virtually all evidence are based on experimental studies carried out in laboratory settings, and there is a need to investigate how this knowledge could translated into improved clinical care. The aim of the current study is to examine whether the communication style between the nursing staff and the patient during analgesic administration will affect the results of pain relief treatment in the mother-newborn ward after cesarean section. As another goal, the study will examine whether relevant patient's characteristics will predict the effectiveness of the treatment.
Detailed description
The study will be carried out in the maternity ward at Carmel Hospital. The study population will include patients who are about to undergo an elective caesarean section under spinal anesthesia. The recruitment will be done pre-surgery. Following consent, participants will receive an explanation about how to assess pain and will fill out the research questionnaires. Communication is the independent variable in this study , which has 2 levels - the increased communication arm and the normal communication arm. Each arm will include 40 patients that will be randomly divided between the arms. The dependent variable is the treatment efficacy, based on the changes in the intensity of the patient's pain one hour after the administration of analgesic. The Self-Consciousness Scale (SCS-R) and the Short suggestibility scale (SSS) will be used to assess relevant personality traits.
Interventions
BEHAVIORALCommunication style
The verbal communication between the nurse and the patient at the time of analgesic administration
Sponsors
University of Haifa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
At the time of analgesic request the nurse will open an envelop in which the participant assignment will be described. While the nurse (the communicator) is not blinded, the participants are blinded. The pain intensity reports will be recoded by the participants via a secured link, hence the participants are also the outcome assessor.
Intervention model description
Parallel design - subjects are allocated into one of two study arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Be able to provide signed and dated written informed consent and to be compliant with the schedule of protocol assessments. * Females aged 18 till 50 * Undergoing cesarean section
Exclusion criteria
\* Mental retardation and cognitive impairment study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity on the 0-10 pain scale | one hour | Change in pain intensity one hour following administration of analgesics |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Self-Consciousness Scale (SCS-R) | Once, at baseline | Assessment of direction of attention. Three variables are calculated (private and public attention and social anxiety) |
| The Short suggestibility scale (SSS) | Once, at baseline | Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility |
Countries
Israel
Contacts
Primary ContactVered Cohen, BA
Outcome results
None listed