The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors

NCT ID: NCT06609772

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2025-06-30

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.

Conditions

Quality of Life; Living-donor Liver Transplantation; Chronic Post Operative Pain; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Individualized pain education group

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.

Group Type: EXPERIMENTAL

Individualised Pain Education

Intervention Type: OTHER

Individualised Pain Education

Interventions

Individualised Pain Education

Individualised Pain Education

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nazlican Bagci

OTHER

Sponsor Role: lead

Responsible Party

Nazlican Bagci

PhD student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Inonu University Liver Transplant Institute

Malatya, Battalgazi, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nazlıcan BAĞCI, MsC

Role: CONTACT

38212703001@ogr.inonu.edu.tr

+90-553-034-01-98 ext. +905530340198

Runida DOĞAN, PhD

Role: CONTACT

runida.dogan@inonu.edu.tr

+905057780690

Facility Contacts

Sezai Yılmaz, Prof. Dr.

Role: primary

Mail.nazlicanbagci@gmail.com

+904223773000 ext. +905530340198

Nazlıcan Bağcı, MsC

Role: backup

Runida Doğan, PhD

Role: backup

Other Identifiers

2024/6148

Identifier Type: -

Identifier Source: org_study_id