Structured Education and Multidisciplinary Team

Not Applicable

Completed

• Conditions: Pain; Anxiety; Activities of Daily Living
• Interventions: Other: Education Group

• Registration Number: NCT04850586
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

It is well-known that pre-operative education has a positive effect on patient recovery. This study was conducted to evaluate the impact of structured education given by a multidisciplinary team (surgeon, anesthesiologist, and nurse) on pain, anxiety, and activities of daily living in patients undergoing laparoscopic cholecystectomy.

Detailed Description

In this randomized controlled study was conducted with 60 patients undergoing elective laparoscopic cholecystectomy in a training and research hospital in Turkey between March and August 2019. The participants were divided into two equal groups. Verbal structured education and written documents were given to the training group before surgery by a multidisciplinary team. The control group had the routine education. Data were collected using a Patient Information Form, the State Anxiety Inventory, a visual analog scale, and the Barthel Index for Activities of Daily Living.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-08-29
• Study Completion: 2019-11-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Last Update Submitted: 2021-04-18
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• undergoing an elective laparoscopic cholecystectomy
• no loss of sensation related to vision and hearing
• opening to communication and cooperation
• no cancer diagnosis
• no chronic pain-related treatment
• no psychological disease diagnosis
• agreeing to participate in the study

Exclusion Criteria

• undergoing emergency surgery
• hospitalized in the intensive care unit
• average score below 62 by Barthel Index

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Group	Education Group	The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.

Primary Outcome Measures

Name	Time	Method
The difference in pain scores measured by Visual Analog Scale between the two groups	The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.	This scale is a unidimensional, valid and reliable scale in the measurement of acute pain intensity. This scale, which is comprised horizontally or vertically, consists of a 10 cm scale, at one end there is "no pain", at the other end there is "worst imaginable pain," with which the patient scores their pain. As the score on the scale increases, the severity of pain intensity increases.

Secondary Outcome Measures

Name	Time	Method
The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups	The independence levels of the patients in both groups were evaluated using the Barthel Daily Living Activities Index on the 10th-day follow-up appointment.	This index consists of 10 items (feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers (e.g. bed to chair and back), mobility on level surfaces (e.g. stairs), and questions the physical competence of the individual. Each item (unable, needs help, independent) is scored between 0-15 and 0-20 indicates total dependency; 21-61 indicates severe dependency, 62-90 indicates moderate dependency, 91-99 indicates slight dependency, and 100 indicates independence.
The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups	Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).	The STAI measures two types of anxiety, state anxiety and trait anxiety. State Anxiety Inventory (STAI-I) is a sensitive tool for evaluating sudden changes in emotional reactions. It requires the individual to describe how they feel at a particular moment and under certain conditions and to respond by considering their feelings about the situation they are in. The scale consists of 20 items and the responses range from 1 to 4. The total score of the scale range from 20 to 80. High scores from the scale indicate high levels of anxiety and low scores indicate low levels of anxiety.

Trial Locations

Locations (1)

Saglık Bilimleri Universitesi; 🇹🇷 Istanbul, Turkey