Post-operative PainNCT06258239
Influence of the Communication Between the Nursing Staff and the Patient on the Analgesic Treatment Effectiveness After Surgery
A study testing Communication between nursing staff and participants in people with Post-operative Pain, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Communication between nursing staff and participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 1330311
Limor Issa, MA, 0506227827, lemor3@gmail.com
About this study
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.
Read more
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.
Read the detailed description
We will assess whether the communication style between the nursing staff and the patient will affect the effectiveness of the analgesic treatment after surgery. Communication is the independent variable in this study. Two approaches with be used in this study - increased communication and normal communication styles: Increased communication and normal (or standard). In the increased communication study arm the nurse will say to the patient (before administration of first bolus): "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 (NSAIDS). 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 (the nurse) 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". In the normal communication study arm the communication between the nurse and patients will be as usual in clinical practice - i.e. - no instructions are given to the nurses regarding on how to communicate with patients.
All participants in the study, regardless of the study conditions to which they will be placed, will receive exactly the same pain management protocol as it is accepted in the clinical field. The patient's participation in the study will not have any influence on the treatment he will receive. Only patients who reported pain of 7 or more and who can receive the research treatment (blood oxygen level 92% or higher, heart rate over 50) will be included in the data analysis. Since the data analysis will include only cases in which a pain of 7 or more was reported, we will only detail the treatment protocol of these cases. According to the pain relief protocol (Appendix 1) implemented in the recovery department, the patients will receive both opioids and additional treatment, according to the following guidelines: administration of morphine by impulse (I.V), in doses of 3 mg up to a total of 4 doses (12 mg) on demand at 10 minute intervals, and at the same time with each dose additional treatment is given. As long as the patient reports pain higher than 3, we will continue to give impulse doses (up to 4 doses).
In addition to each dose of morphine, a second treatment will be administered according to the following protocol: the patient suffering from pain will usually receive a first dose of morphine and at the same time will receive IV Xefo, which is a drug from the Non-steroidal anti-inflammatory drugs (NSAID) family. At the second pain assessment (about 10 minutes later), if the patient is still suffering from pain, he will receive a second dose of morphine and at the same time IV Optalgin (on the condition that the patient did not receive this drug in the operating room). At the third pain assessment, if the patient is still suffering from pain, he will receive a third dose of morphine and at the same time IV Paracetamol. Finally, at the fourth pain assessment, if the patient reports that he is still suffering from pain, he will receive a fourth dose of morphine alone (without any additional treatment).
The assessment of treatment effectiveness will be based on two key variables: the intensity of the patient's pain and the number of doses of opioids. The nursing staff member will contact the patient at five time points, once every 10 minutes in order to assess his pain. Pain evaluation will be carried out by a verbal scale (NRS, numerical rating scale 0-10). The number of doses of opioids the patient received (ranging from 1 to 4), which represent a total of four different doses (3, 6, 9 or 12 ml), will be noted. We will assess the personality traits and expectation of pain by asking: how severe do you expect your pain to be after surgery on a scale from 0-10? Self-awareness will be assessed using the Self-Consciousness Scale (SCS-R). Empathy of the therapist will be assessed with two questionnaires: Consultation And Relational Empathy measure (CARE) and the Toronto Empathy Questionnaire (TEQ). The general tendency of a person to respond to the suggestions of others will be assessed by the Short Suggestibility Scale questionnaire (SSS) and optimism will be assessed by Life Orientation Test questionnaire (LOT-R). All questionnaires are in both Hebrew and Arabic languages. In addition, we will use physiological indicators that are collected in the clinical routine in the department including: blood pressure, pulse, saturation (blood oxygen level), respiratory rate, body temperature, level of alertness, pain assessment, documentation of painkillers administration, skin integrity assessment, surgical wound assessment.
- Conditions
- Post-operative Pain
- Being tested
- Communication between nursing staff and participants
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication between nursing staff and participantsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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. Receives: Other: Communication between nursing staff and participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
A 0-10 VAS scale ranging "no pain" to "worst imaginable pain"
Measured: 1 day (At five time points, every 10 minutes)
Opioids consumption
Number of doses of opioids requested
Measured: 1 day (Up to 4 time points, every 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Apr 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design - subjects are allocated into one of two study arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roi Treister, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258239
- Sponsor's protocol ID
- 0128-22-ZIV
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Communication Between the Nursing Staff and the Patient on the Analgesic Treatment Effectiveness After Surgery
- ClinicalTrials.gov ID
- NCT06258239
- Acronym / sponsor ID
- 0128-22-ZIV
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will assess whether the communication style between the nursing staff and the patient will affect the effectiveness of the analgesic treatment after surgery. Communication is the independent variable in this study. Two approaches with be used in this study - increased communication and normal communication styles: Increased communication and normal (or standard). In the increased communication study arm the nurse will say to the patient (before administration of first bolus): "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 (NSAIDS). 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 (the nurse) 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". In the normal communication study arm the communication between the nurse and patients will be as usual in clinical practice - i.e. - no instructions are given to the nurses regarding on how to communicate with patients.
All participants in the study, regardless of the study conditions to which they will be placed, will receive exactly the same pain management protocol as it is accepted in the clinical field. The patient's participation in the study will not have any influence on the treatment he will receive. Only patients who reported pain of 7 or more and who can receive the research treatment (blood oxygen level 92% or higher, heart rate over 50) will be included in the data analysis. Since the data analysis will include only cases in which a pain of 7 or more was reported, we will only detail the treatment protocol of these cases. According to the pain relief protocol (Appendix 1) implemented in the recovery department, the patients will receive both opioids and additional treatment, according to the following guidelines: administration of morphine by impulse (I.V), in doses of 3 mg up to a total of 4 doses (12 mg) on demand at 10 minute intervals, and at the same time with each dose additional treatment is given. As long as the patient reports pain higher than 3, we will continue to give impulse doses (up to 4 doses).
In addition to each dose of morphine, a second treatment will be administered according to the following protocol: the patient suffering from pain will usually receive a first dose of morphine and at the same time will receive IV Xefo, which is a drug from the Non-steroidal anti-inflammatory drugs (NSAID) family. At the second pain assessment (about 10 minutes later), if the patient is still suffering from pain, he will receive a second dose of morphine and at the same time IV Optalgin (on the condition that the patient did not receive this drug in the operating room). At the third pain assessment, if the patient is still suffering from pain, he will receive a third dose of morphine and at the same time IV Paracetamol. Finally, at the fourth pain assessment, if the patient reports that he is still suffering from pain, he will receive a fourth dose of morphine alone (without any additional treatment).
The assessment of treatment effectiveness will be based on two key variables: the intensity of the patient's pain and the number of doses of opioids. The nursing staff member will contact the patient at five time points, once every 10 minutes in order to assess his pain. Pain evaluation will be carried out by a verbal scale (NRS, numerical rating scale 0-10). The number of doses of opioids the patient received (ranging from 1 to 4), which represent a total of four different doses (3, 6, 9 or 12 ml), will be noted. We will assess the personality traits and expectation of pain by asking: how severe do you expect your pain to be after surgery on a scale from 0-10? Self-awareness will be assessed using the Self-Consciousness Scale (SCS-R). Empathy of the therapist will be assessed with two questionnaires: Consultation And Relational Empathy measure (CARE) and the Toronto Empathy Questionnaire (TEQ). The general tendency of a person to respond to the suggestions of others will be assessed by the Short Suggestibility Scale questionnaire (SSS) and optimism will be assessed by Life Orientation Test questionnaire (LOT-R). All questionnaires are in both Hebrew and Arabic languages. In addition, we will use physiological indicators that are collected in the clinical routine in the department including: blood pressure, pulse, saturation (blood oxygen level), respiratory rate, body temperature, level of alertness, pain assessment, documentation of painkillers administration, skin integrity assessment, surgical wound assessment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel design - subjects are allocated into one of two study arms
| Arm | Type | Receives |
|---|---|---|
| Enhanced communication | Other | Other: Communication between nursing staff and participantsIn 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". |
| Normal communication | Other | Other: Communication between nursing staff and participantsIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication between nursing staff and participantsThe 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. | Other | Enhanced communication, Normal communication |
Primary outcome
Pain intensity
Time frame: 1 day (At five time points, every 10 minutes)
A 0-10 VAS scale ranging "no pain" to "worst imaginable pain"
Opioids consumption
Time frame: 1 day (Up to 4 time points, every 10 minutes)
Number of doses of opioids requested
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roi Treister, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication between nursing staff and participants in people with Post-operative Pain, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roi Treister, PhD (0533839935, rtreister@univ.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 1 day (At five time points, every 10 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.