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

NCT ID: NCT05970029

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-03-01

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Enhanced communication

In the enhanced communication study arm the nurse will say to the patient: "I will now give you our first line analgesic medication, liquid Dipyrone. It is a very efficient treatment and based on my experience you will very soon feel significant pain relief".

Group Type: EXPERIMENTAL

Communication style

Intervention Type: BEHAVIORAL

The verbal communication between the nurse and the patient at the time of analgesic administration

Normal communication

In the normal communication study arm the communication between the nurse and patients will be as usual in clinical practice - i.e. - no instruction are given to the nurses regarding on how to communicate with patients while administrating the treatment.

Group Type: OTHER

Communication style

Intervention Type: BEHAVIORAL

The verbal communication between the nurse and the patient at the time of analgesic administration

Interventions

Communication style

The verbal communication between the nurse and the patient at the time of analgesic administration

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vered Cohen, BA

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Vered Cohen, BA

Role: CONTACT

golanv35@walla.co.il

972-525213440

Facility Contacts

Vered Cohen

Role: primary

veredcohen1@clalit.org.il

+972525213440

Other Identifiers

0014-23-CMC

Identifier Type: -

Identifier Source: org_study_id