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

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Communication style
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Enhanced communication

Normal communication

Arm Description

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".

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.

Outcomes

Primary Outcome Measures

Change in pain intensity on the 0-10 pain scale
Change in pain intensity one hour following administration of analgesics

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
July 23, 2023
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT05970029
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel design - subjects are allocated into one of two study arms
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced communication
Arm Type
Experimental
Arm Description
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".
Arm Title
Normal communication
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Communication style
Intervention Description
The verbal communication between the nurse and the patient at the time of analgesic administration
Primary Outcome Measure Information:
Title
Change in pain intensity on the 0-10 pain scale
Description
Change in pain intensity one hour following administration of analgesics
Time Frame
one hour
Other Pre-specified Outcome Measures:
Title
The Self-Consciousness Scale (SCS-R)
Description
Assessment of direction of attention. Three variables are calculated (private and public attention and social anxiety)
Time Frame
Once, at baseline
Title
The Short suggestibility scale (SSS)
Description
Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility
Time Frame
Once, at baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only woman undergoing cesarian section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vered Cohen, BA
Phone
972-525213440
Email
golanv35@walla.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vered Cohen, BA
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vered Cohen
Phone
+972525213440
Email
veredcohen1@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A link to the data location will be published in the article summarizing the results

Learn more about this trial

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

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