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

NCT05970029 | Unknown

• 1 other identifier: 0014-23-CMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity on the 0-10 pain scale

  Change in pain intensity one hour following administration of analgesics

  one hour

Other Outcomes (2)

• The Self-Consciousness Scale (SCS-R)

  Once, at baseline

• The Short suggestibility scale (SSS)

  Once, at baseline

Study Arms (2)

Enhanced communication

EXPERIMENTAL

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".

Behavioral: Communication style

Normal communication

OTHER

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.

Behavioral: Communication style

Interventions

Communication style BEHAVIORAL

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

Enhanced communication; Normal communication

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only woman undergoing cesarian section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \* Mental retardation and cognitive impairment
• study.

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vered Cohen, BA

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered Cohen, BA

CONTACT

972-525213440; golanv35@walla.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel design - subjects are allocated into one of two study arms

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: August 1, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)