Influence of the Communication Between the Nursing Staff and the Patient on the Analgesic Treatment Effectiveness After Surgery

NCT06258239 | Unknown

• 1 other identifier: 0128-22-ZIV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pain is a normal response to tissue injury or disease and has an important biological function. It is adaptive and promotes recuperation by restricting behaviors that might incur further tissue trauma. In the case of post-operative acute pain, the cause and time of the physical injury are known, and because the condition is self-limiting it requires only short-term care. However, if acute pain responses cannot be adequately suppressed, cardiac, pulmonary and neuroendocrine functions may be compromised, and the immune system suppressed. Inadequate management of post-operative acute pain is a major burden for healthcare services and can contribute to medical complications including inflammation of the respiratory tract, damage to the oxygen supply to the heart muscle, deep vein thrombosis, delayed healing as well as the development of chronic pain, more difficult to treat. In addition, suboptimal management of pain after surgery may impair sleep and have negative psychological effects, such as anxiety, fear and lack of sleep. Proper treatment of pain reduces morbidity, damages, treatment costs, improves the patient's quality of life and his chances of a full recovery. It is therefore essential that all patients undergoing surgery should receive adequate pain management. Despite years of advances in pain management, the mainstay of postoperative pain therapy in many settings is still opioids. Morphine is the most commonly used opioid to treat moderate to severe pain after surgery in the recovery unit. The growing concern about the significant side effects, addictions and costs of opioids as a drug treatment has led to an urgent need to identify other agents and approaches to postoperative pain management that are effective, safe and cheap. The main purpose of this study is to examine whether the type of communication between the nursing staff and the patient will affect the results of pain relief treatment in the postoperative recovery department. As a secondary objective, we will examine whether personality traits will predict the effectiveness of the treatment.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  A 0-10 VAS scale ranging "no pain" to "worst imaginable pain"

  1 day (At five time points, every 10 minutes)

• Opioids consumption

  Number of doses of opioids requested

  1 day (Up to 4 time points, every 10 minutes)

Study Arms (2)

Enhanced communication

OTHER

In the enhanced communication study arm the nurse will say to the patient: "I will now give you a combination of two drugs that will greatly ease your pain. One of the two drugs is morphine, which is a drug from the opioid family, which is the strongest drug family for pain relief that medicine has to offer. This drug is very effective against severe pain after surgery. In addition, the second drug is called XEFO. This drug is from the family of non-steroidal anti-inflammatory drugs. We know that the combination of these two drugs is particularly successful in reducing the kind of pain that you experience. According to my experience, you will feel significant pain relief very soon. I will come to you every 10 minutes to assess if you are still in pain. As long as you are suffering from pain, I will continue to give you additional doses of the treatment. We are allowed to give up to 4 doses of treatment. As the treatment is very strong, not everyone needs all 4 doses".

Other: Communication between nursing staff and participants

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.

Other: Communication between nursing staff and participants

Interventions

Communication between nursing staff and participants OTHER

The analgesic treatment that will be given are part of clinical routine - the participants will get the same exact treatment regardless if they entered the study and to which study arm they entered. The effect that we are interested to capture is the potential added value of communication between the nursing staff and participants while administrating analgesics.

Enhanced communication; Normal communication

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be considered eligible to participate to this study, patients have to be able to provide signed and dated written informed consent and to be compliant with the schedule of protocol assessments. Both gender aged 18 till 80, with creatinine levels under 1.4 and undergoing one of following surgery under general anesthesia will be eligible for this study: Gallbladder surgery, hemorrhoid surgery, hernia surgery, nasal septum correction surgery, endoscopic surgery of the sinuses.

You may not qualify if:

• Patients with creatinine levels above 1.4, weighing less than 50 kg and patients with mental retardation and cognitive impairment will not be enrolled in this study.

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Ziv Medical Center

Safed, 1330311, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Roi Treister, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roi Treister, PhD

CONTACT

0533839935; rtreister@univ.haifa.ac.il

Limor Issa, MA

CONTACT

0506227827; lemor3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Nursing staff who will administer the treatment will not be blinded, given that they will receive instructions regarding text to be communicated with participants while administrating the treatment. The participants and the outcomes assessors will not know which study arm they entered (both will be blinded).
• Purpose: HEALTH SERVICES RESEARCH
• 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: February 6, 2024
• First Posted: February 14, 2024
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 14, 2024

Record last verified: 2023-03

Locations

IL (1)