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

Sponsor
University of Haifa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05970029
Collaborator
(none)
80
1
2
9
8.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Communication style
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel design - subjects are allocated into one of two study armsParallel design - subjects are allocated into one of two study arms
Masking:
Double (Participant, 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.
Primary Purpose:
Other
Official Title:
Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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".

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

Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in pain intensity on the 0-10 pain scale [one hour]

    Change in pain intensity one hour following administration of analgesics

Other Outcome Measures

  1. 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)

  2. The Short suggestibility scale (SSS) [Once, at baseline]

    Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carmel Medical Center Haifa Israel

Sponsors and Collaborators

  • University of Haifa

Investigators

  • Principal Investigator: Vered Cohen, BA, Carmel Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Haifa
ClinicalTrials.gov Identifier:
NCT05970029
Other Study ID Numbers:
  • 0014-23-CMC
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023