Clinical trial NCT06609772: The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors
Official title: The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Chronic Postoperative Pain Development
timeFrame: 120 days
measure: Chronic Postoperative Pain Development
timeFrame: 120 days
measure: Quality of Life
timeFrame: 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Liver Transplant Institute
state: Battalgazi
Study officials:
References: