Clinical trial NCT05970029: Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section
Official title: Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design - subjects are allocated into one of two study arms
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity on the 0-10 pain scale
timeFrame: one hour
Secondary outcomes:
Other outcomes:
measure: The Self-Consciousness Scale (SCS-R)
timeFrame: Once, at baseline
measure: The Short suggestibility scale (SSS)
timeFrame: Once, at baseline
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Vered Cohen, BA
role: PRINCIPAL_INVESTIGATOR
References: