Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section

Acute Pain Clinical Trial

Official title:

Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970029
• Other study ID #: 0014-23-CMC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2023
• Source: University of Haifa
• Contact: Vered Cohen, BA
• Phone: 972-525213440
• Email: golanv35[@]walla.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Behavioral:
• Communication style
The verbal communication between the nurse and the patient at the time of analgesic administration

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Self-Consciousness Scale (SCS-R)	Assessment of direction of attention. Three variables are calculated (private and public attention and social anxiety)	Once, at baseline
Other	The Short suggestibility scale (SSS)	Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility	Once, at baseline
Primary	Change in pain intensity on the 0-10 pain scale	Change in pain intensity one hour following administration of analgesics	one hour