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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNazlican Bagci

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

No condition that prevents communication

Having the ability to read and write

No major complications in the early postoperative period

No previous abdominal surgery

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individualised Pain Education

    Other intervention

    Individualised Pain Education

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Individualized pain education groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
120 days
2

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).

Time frame
120 days
3

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).

Time frame
120 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nazlican Bagci

Lead sponsor

Inonu University

Sponsor institution