Quality of LifeNCT06609772
The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors
A study testing Individualised Pain Education in people with Quality of Life and Living-donor Liver Transplantation, run by Nazlican Bagci at 1 site in Turkey (Türkiye).
Trial summary
Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life, Living-donor Liver Transplantation, Chronic Post Operative Pain
- What is being tested?
- Individualised Pain Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2024to Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No condition that prevents communication
- Having the ability to read and write
- No major complications in the early postoperative period
- No previous abdominal surgery
- No additional disease that may cause chronic pain
Who cannot join
- Having any condition that prevents communication
- Lack of reading and writing skills
- Having a major complication in the early postoperative period
- Having had abdominal surgery before
- Having an additional disease that may cause chronic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University Liver Transplant Institute
Malatya, Battalgazi, 44000
Sezai Yılmaz, Prof. Dr., +904223773000 ext. +905530340198, Mail.nazlicanbagci@gmail.com
Nazlıcan Bağcı, MsC
About this study
Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. Chronic postoperative pain, as a major complication of surgery, increases the use of analgesics, restricts activities of daily living, reduces quality of life and creates a serious economic burden. Prolonged pain in the preoperative period and poorly treated postoperative acute pain may trigger the development of chronic pain. Chronic postoperative pain is an important and current problem in living liver transplant donors as in many patient groups.
Chronic pain due to severe postoperative acute pain is reported as an expected outcome after open surgical resection in living liver transplant donors. The reason for this is thought to be inadequate perioperative pain management. Inadequate perioperative pain management may lead to sub-optimal pain management, delayed recovery, unexpected readmissions, decreased patient satisfaction, prolonged duration of opioid analgesia with potential for narcotic abuse, and clinical, psychological and socioeconomic consequences that may possibly lead to chronic postoperative pain. Chronic postoperative pain is a common but overlooked complication of surgery that can cause functional limitation, psychological distress and poor quality of life in patients and its management is very important for nurses. An important aim of nursing care is to help liver living donors regain their health and quality of life. Providing management of acute postoperative pain, preventing the development of chronic postoperative pain and improving quality of life in patients undergoing surgical procedures are important issues for nurses. At the same time, chronic postoperative pain management, as a very current issue, requires nurses to plan and implement more effective interventions. With appropriate pain interventions in the preoperative and early postoperative period, the patient should be educated and counselled about self-management strategies, return to normal functionality and the possibility of developing chronic pain after surgery. Adequate perioperative education about the surgery and expected outcomes may alleviate stress, reduce the severity of acute pain and help prevent chronic postoperative pain.
Read more
It is thought that individualised pain education will be effective on chronic postoperative pain development and quality of life of patients. When the literature was reviewed, no study on individualised pain education for liver living donors was found. At the same time, no study was found in the literature in which chronic postoperative pain and quality of life were examined together in liver living donors. The fact that the subject will be investigated for the first time adds originality to the study.
With this study, the effect of individualised pain education on prevention or reduction of chronic postoperative pain and improvement of quality of life will be determined. Thus, the data obtained can be evaluated holistically and can form the basis for new and large-scale studies in the related field. At the same time, in this prospective study, the rates and characteristics of chronic postoperative pain development in liver living donors at the 3rd month after transplantation will be evaluated. Thus, this study will contribute to the limited literature on this subject.
Research Hypotheses:
H0a: Individualized pain education applied to living liver donors is not effective on the development of chronic postoperative pain.
H1a: Individualized pain education applied to living liver donors is effective on the development of chronic postoperative pain.
H0b: Individualized pain education applied to living liver donors is not effective on the quality of life of patients.
H1b: Individualized pain education applied to living liver donors is effective on the quality of life of patients.
Read the detailed description
Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. As a common condition, it affects approximately 5% to 85% of all surgical patients. Chronic postoperative pain, as a major complication of surgery, increases the use of analgesics, restricts activities of daily living, reduces quality of life and creates a serious economic burden. It also causes negative consequences such as anxiety, depression, sleep disorders and opioid use disorders. Prolonged pain in the preoperative period and poorly treated postoperative acute pain may trigger the development of chronic pain. It has also been reported that factors such as young age, female gender, high body mass index, smoking, fear, anxiety, and duration of surgery may be associated with chronic postoperative pain. Chronic postoperative pain is an important and current problem in living liver transplant donors as in many patient groups. Although limited data are available, some studies report that donors experience chronic pain beyond the expected normal recovery period.
Chronic pain due to severe postoperative acute pain is reported as an expected outcome after open surgical resection in living liver transplant donors. The reason for this is thought to be inadequate perioperative pain management. Inadequate perioperative pain management may lead to sub-optimal pain management, delayed recovery, unexpected readmissions, decreased patient satisfaction, prolonged duration of opioid analgesia with potential for narcotic abuse, and clinical, psychological and socioeconomic consequences that may possibly lead to chronic postoperative pain. Chronic postoperative pain is a common but overlooked complication of surgery that can cause functional limitation, psychological distress and poor quality of life in patients and its management is very important for nurses. An important aim of nursing care is to help liver living donors regain their health and quality of life. Providing management of acute postoperative pain, preventing the development of chronic postoperative pain and improving quality of life in patients undergoing surgical procedures are important issues for nurses. At the same time, chronic postoperative pain management, as a very current issue, requires nurses to plan and implement more effective interventions. With appropriate pain interventions in the preoperative and early postoperative period, the patient should be educated and counselled about self-management strategies, return to normal functionality and the possibility of developing chronic pain after surgery. Adequate perioperative education about the surgery and expected outcomes may alleviate stress, reduce the severity of acute pain and help prevent chronic postoperative pain.
- Conditions
- Quality of Life, Living-donor Liver Transplantation, Chronic Post Operative Pain, Pain Management
- Being tested
- Individualised Pain Education
- Keywords
- Living Liver Donors, Chronic Postoperative Pain, Individualised Pain Education, Quality of Life
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised Pain EducationOther
Individualised Pain Education
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | After obtaining the necessary legal and ethical permissions for data collection, the research will commence. During this stage of the study, participants who agree to take part in the research will be asked to fill out the informed consent form. To obtain the pre-test data for the research, all forms will be filled out. The patients will be called by the researcher on the 15th, 45th and 75th days to perform interim measurements (Interim measurement-1, Interim measurement-2, Interim measurement-3). On the 90th and 120th days, the patients will be called again by the researcher and the final tests will be applied. |
| Individualized pain education group | Experimental | During this stage of the study, participants who agree to take part in the research will be asked to fill out the informed consent form. The individualized pain education program is planned to be applied to all patients on the 6th postoperative day. To obtain the pre-test data for the research, all forms will be filled out. Individual education will be given to the patients in the experimental group in their own rooms and all questions asked by the patient will be answered after the education. The education booklet will be given to the patients after the individual education program. The patients in the experimental group will be informed that they will be called via video call for the 30th and 60th day reminder education. The patients will be called by the researcher on the 15th, 45th and 75th days to perform interim measurements. On the 90th and 120th days, the patients will be called again by the researcher and the final tests will be applied. Receives: Other: Individualised Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Postoperative Pain Development
Whether Chronic Postoperative Pain develops or not will be evaluated using the numeric rating scale (NRS). In NRS, the patient is asked to give a numerical score for their pain between 0 and 10 or 0 and 100. On the scale, 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain. NRS is an easy and understandable method.
Measured: 120 days
Chronic Postoperative Pain Development
In the presence of Chronic Postoperative Pain, the pain will be assessed using the McGill-Melzack Pain Questionnaire (MASF). With the scale; the location of the pain in the first part, the characteristics of the pain in the second part, the variables that reduce and increase the pain in the third part and the severity of the pain in the fourth part. The total score is calculated in the scale (0-112).
Measured: 120 days
Quality of Life
It Quality of Life will be assessed using the EuroQol 5-Dimensional 3-Level (EQ-5D-3L) General Quality of Life Scale.
The EQ-5D consists of a thermometer-like visual analog scale (EQ-VAS) anchored by 0 (worst health) and 100 (best health) to assess health status at the time of assessment and a 5-item descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three levels of responses reflecting no, moderate, and extreme problems. The response pattern in these 5 items can be converted into a single index score, anchored between zero (for death) and 1 (perfect health).
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start19 Jul 2024
- Primary completion15 Apr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Power analysis was performed to calculate the sample size of this study. According to the calculation made using the G\*power 3.1 program; the sample size was determined as 110 (55 experimental, 55 control) with an effect size of 0.22, a margin of error of 0.05, a confidence level of 0.95, and a universe representation power of 0.95. Considering the possible losses that may occur for any reason, it was planned to include 120 individuals (60 experimental, 60 control) who are living liver donors in the study. In this study, the randomization method will be used in assigning the participants to the control and experimental groups. Thus, it was aimed to protect the randomization in case of data loss. Computer-assisted randomization will be used for randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazlican Bagci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazlican Bagci, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609772
- Sponsor's protocol ID
- 2024/6148
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is a doctoral thesis study. The research is expected to be completed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors
- ClinicalTrials.gov ID
- NCT06609772
- Acronym / sponsor ID
- 2024/6148
- Conditions
- Quality of Life, Living-donor Liver Transplantation, Chronic Post Operative Pain, Pain Management
- Keywords
- Living Liver Donors, Chronic Postoperative Pain, Individualised Pain Education, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nazlican BagciUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Sep 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.
Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. Chronic postoperative pain, as a major complication of surgery, increases the use of analgesics, restricts activities of daily living, reduces quality of life and creates a serious economic burden. Prolonged pain in the preoperative period and poorly treated postoperative acute pain may trigger the development of chronic pain. Chronic postoperative pain is an important and current problem in living liver transplant donors as in many patient groups.
Chronic pain due to severe postoperative acute pain is reported as an expected outcome after open surgical resection in living liver transplant donors. The reason for this is thought to be inadequate perioperative pain management. Inadequate perioperative pain management may lead to sub-optimal pain management, delayed recovery, unexpected readmissions, decreased patient satisfaction, prolonged duration of opioid analgesia with potential for narcotic abuse, and clinical, psychological and socioeconomic consequences that may possibly lead to chronic postoperative pain. Chronic postoperative pain is a common but overlooked complication of surgery that can cause functional limitation, psychological distress and poor quality of life in patients and its management is very important for nurses. An important aim of nursing care is to help liver living donors regain their health and quality of life. Providing management of acute postoperative pain, preventing the development of chronic postoperative pain and improving quality of life in patients undergoing surgical procedures are important issues for nurses. At the same time, chronic postoperative pain management, as a very current issue, requires nurses to plan and implement more effective interventions. With appropriate pain interventions in the preoperative and early postoperative period, the patient should be educated and counselled about self-management strategies, return to normal functionality and the possibility of developing chronic pain after surgery. Adequate perioperative education about the surgery and expected outcomes may alleviate stress, reduce the severity of acute pain and help prevent chronic postoperative pain.
It is thought that individualised pain education will be effective on chronic postoperative pain development and quality of life of patients. When the literature was reviewed, no study on individualised pain education for liver living donors was found. At the same time, no study was found in the literature in which chronic postoperative pain and quality of life were examined together in liver living donors. The fact that the subject will be investigated for the first time adds originality to the study.
With this study, the effect of individualised pain education on prevention or reduction of chronic postoperative pain and improvement of quality of life will be determined. Thus, the data obtained can be evaluated holistically and can form the basis for new and large-scale studies in the related field. At the same time, in this prospective study, the rates and characteristics of chronic postoperative pain development in liver living donors at the 3rd month after transplantation will be evaluated. Thus, this study will contribute to the limited literature on this subject.
Research Hypotheses:
H0a: Individualized pain education applied to living liver donors is not effective on the development of chronic postoperative pain.
H1a: Individualized pain education applied to living liver donors is effective on the development of chronic postoperative pain.
H0b: Individualized pain education applied to living liver donors is not effective on the quality of life of patients.
H1b: Individualized pain education applied to living liver donors is effective on the quality of life of patients.
Detailed description
Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. As a common condition, it affects approximately 5% to 85% of all surgical patients. Chronic postoperative pain, as a major complication of surgery, increases the use of analgesics, restricts activities of daily living, reduces quality of life and creates a serious economic burden. It also causes negative consequences such as anxiety, depression, sleep disorders and opioid use disorders. Prolonged pain in the preoperative period and poorly treated postoperative acute pain may trigger the development of chronic pain. It has also been reported that factors such as young age, female gender, high body mass index, smoking, fear, anxiety, and duration of surgery may be associated with chronic postoperative pain. Chronic postoperative pain is an important and current problem in living liver transplant donors as in many patient groups. Although limited data are available, some studies report that donors experience chronic pain beyond the expected normal recovery period.
Chronic pain due to severe postoperative acute pain is reported as an expected outcome after open surgical resection in living liver transplant donors. The reason for this is thought to be inadequate perioperative pain management. Inadequate perioperative pain management may lead to sub-optimal pain management, delayed recovery, unexpected readmissions, decreased patient satisfaction, prolonged duration of opioid analgesia with potential for narcotic abuse, and clinical, psychological and socioeconomic consequences that may possibly lead to chronic postoperative pain. Chronic postoperative pain is a common but overlooked complication of surgery that can cause functional limitation, psychological distress and poor quality of life in patients and its management is very important for nurses. An important aim of nursing care is to help liver living donors regain their health and quality of life. Providing management of acute postoperative pain, preventing the development of chronic postoperative pain and improving quality of life in patients undergoing surgical procedures are important issues for nurses. At the same time, chronic postoperative pain management, as a very current issue, requires nurses to plan and implement more effective interventions. With appropriate pain interventions in the preoperative and early postoperative period, the patient should be educated and counselled about self-management strategies, return to normal functionality and the possibility of developing chronic pain after surgery. Adequate perioperative education about the surgery and expected outcomes may alleviate stress, reduce the severity of acute pain and help prevent chronic postoperative pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Power analysis was performed to calculate the sample size of this study. According to the calculation made using the G*power 3.1 program; the sample size was determined as 110 (55 experimental, 55 control) with an effect size of 0.22, a margin of error of 0.05, a confidence level of 0.95, and a universe representation power of 0.95. Considering the possible losses that may occur for any reason, it was planned to include 120 individuals (60 experimental, 60 control) who are living liver donors in the study. In this study, the randomization method will be used in assigning the participants to the control and experimental groups. Thus, it was aimed to protect the randomization in case of data loss. Computer-assisted randomization will be used for randomization.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –After obtaining the necessary legal and ethical permissions for data collection, the research will commence. During this stage of the study, participants who agree to take part in the research will be asked to fill out the informed consent form. To obtain the pre-test data for the research, all forms will be filled out. The patients will be called by the researcher on the 15th, 45th and 75th days to perform interim measurements (Interim measurement-1, Interim measurement-2, Interim measurement-3). On the 90th and 120th days, the patients will be called again by the researcher and the final tests will be applied. |
| Individualized pain education group | Experimental | Other: Individualised Pain EducationDuring this stage of the study, participants who agree to take part in the research will be asked to fill out the informed consent form. The individualized pain education program is planned to be applied to all patients on the 6th postoperative day. To obtain the pre-test data for the research, all forms will be filled out. Individual education will be given to the patients in the experimental group in their own rooms and all questions asked by the patient will be answered after the education. The education booklet will be given to the patients after the individual education program. The patients in the experimental group will be informed that they will be called via video call for the 30th and 60th day reminder education. The patients will be called by the researcher on the 15th, 45th and 75th days to perform interim measurements. On the 90th and 120th days, the patients will be called again by the researcher and the final tests will be applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- No condition that prevents communication
- Having the ability to read and write
- No major complications in the early postoperative period
- No previous abdominal surgery
- No additional disease that may cause chronic pain
Key exclusion criteria (5 listed)
- Having any condition that prevents communication
- Lack of reading and writing skills
- Having a major complication in the early postoperative period
- Having had abdominal surgery before
- Having an additional disease that may cause chronic pain
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 |
|---|---|---|
| Individualised Pain EducationIndividualised Pain Education | Other | Individualized pain education group |
Primary outcome
Chronic Postoperative Pain Development
Time frame: 120 days
Whether Chronic Postoperative Pain develops or not will be evaluated using the numeric rating scale (NRS). In NRS, the patient is asked to give a numerical score for their pain between 0 and 10 or 0 and 100. On the scale, 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain. NRS is an easy and understandable method.
Chronic Postoperative Pain Development
Time frame: 120 days
In the presence of Chronic Postoperative Pain, the pain will be assessed using the McGill-Melzack Pain Questionnaire (MASF). With the scale; the location of the pain in the first part, the characteristics of the pain in the second part, the variables that reduce and increase the pain in the third part and the severity of the pain in the fourth part. The total score is calculated in the scale (0-112).
Quality of Life
Time frame: 120 days
It Quality of Life will be assessed using the EuroQol 5-Dimensional 3-Level (EQ-5D-3L) General Quality of Life Scale. The EQ-5D consists of a thermometer-like visual analog scale (EQ-VAS) anchored by 0 (worst health) and 100 (best health) to assess health status at the time of assessment and a 5-item descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has three levels of responses reflecting no, moderate, and extreme problems. The response pattern in these 5 items can be converted into a single index score, anchored between zero (for death) and 1 (perfect health).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No. This research is a doctoral thesis study. The research is expected to be completed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised Pain Education in people with Quality of Life and Living-donor Liver Transplantation, run by Nazlican Bagci at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 24 Sep 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 Turkey (Türkiye). 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 Nazlıcan BAĞCI, MsC (+90-553-034-01-98 ext. +905530340198, 38212703001@ogr.inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Postoperative Pain Development (time frame: 120 days). The study lists 3 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 24 Sep 2024.